Shoulder Innovations, Inc. develops next generation shoulder replacement implants, utilizing contract manufacturing partners, and distributes them nationwide for surgeries through a network of employed and contracted sales representatives.
The company is a commercial-stage medical technology company exclusively focused on transforming the shoulder surgical care market. The company offers advanced implant systems for shoulder arthroplasty. These systems are a core element of the company’s ecosys...
Shoulder Innovations, Inc. develops next generation shoulder replacement implants, utilizing contract manufacturing partners, and distributes them nationwide for surgeries through a network of employed and contracted sales representatives.
The company is a commercial-stage medical technology company exclusively focused on transforming the shoulder surgical care market. The company offers advanced implant systems for shoulder arthroplasty. These systems are a core element of the company’s ecosystem, which it designed to improve core components of shoulder surgical care – preoperative planning, implant design and procedural efficiency – to benefit each stakeholder in the care chain. The company’s ecosystem is also consisting of enabling technologies, efficient instrument systems, specialized support and surgeon-to-surgeon collaboration.
The company's initial focus within this broader market is on shoulder arthroplasty. Shoulder arthroplasty is an established surgical procedure involving the reconstruction of the shoulder joint with prosthetic implants through one of two main approaches: aTSA and rTSA. Both approaches can be performed in inpatient hospital settings and in outpatient settings, including ambulatory surgery centers (ASCs). A key competitive advantage of the company has been the emergence of ASCs as a cost-efficient site of care with positive outcomes relative to hospital-based care. The company expects that future growth in the shoulder surgical care market will be significantly driven by ASCs as hospitals face capacity constraints and are more limited in their ability to meet increasing demand.
The company developed its ecosystem with an approach to innovation that prioritizes ease of use, flexibility, predictability of outcomes, and site of care efficiency. The company's ecosystem consists of the following elements:
Advanced Implant Systems: The company’s advanced implants include a diverse range of interchangeable InSet anatomic and reverse total shoulder arthroplasty systems that leverage its novel, InSet Glenoid and InSet humeral stem technologies.
ProVoyance Preoperative Planning Technology: This preoperative planning technology integrates AI and ML to transform planar CT imaging into 3D renderings, allowing surgeons to create bespoke surgical plans considering patient-specific anatomy ahead of surgery.
Efficient Instrument System: The company’s efficient instrument system supports both aTSA and rTSA procedures from start to finish with just two convenient trays, considerably less than the six to nine trays typically required by other offerings.
Specialized Support: The company’s team of dedicated shoulder specialists enables it to deliver a highly tailored experience to surgeons operating in a complex and technically demanding procedure category.
Surgeon-to-Surgeon Collaboration: The company’s CEME team fosters a collaborative network of expert surgeon educators and promotes surgeon-to-surgeon training and peer education.
The company's ecosystem offers notable benefits that differentiate it within the shoulder surgical care market.
The company developed its comprehensive implant portfolio to address the unique needs of patients and surgeons. Its advanced implants are comprised of its aTSA and rTSA systems, which include various, specifically designed components capable of a wide array of system configurations to facilitate different modes of operation (anatomic or reverse) that are optimized for patient-specific needs. The company’s InSet Glenoid technology serves as the foundation for its advanced implant systems and includes a novel InSet design that aims to reduce mechanical stress at the bone-implant interface, improve fixation mechanics, enhance stability, and reduce micromotion. The company’s implant systems leverage consistent surgical techniques and the same efficient, two-tray instrumentation system. In addition to its advanced implant systems, the company offers a preoperative surgical planning technology: ProVoyance.
ProVoyance integrates AI and ML to transform planar CT imaging into 3D renderings of patient-specific anatomy ahead of surgery, and is cleared by the U.S. Food and Drug Administration (the FDA) for preoperative shoulder planning. ProVoyance received 510(k) clearance in 2021 and is classified by the FDA as a Class II device. ProVoyance is listed on the FDA’s AI/ML-enabled medical devices list, which is a resource maintained, published, and periodically updated by the FDA to identify AI/ML-enabled devices that have been authorized for marketing in the United States through any of the standard paths to market for medical devices, although it is not intended to be a comprehensive list of all such devices that incorporate AI/ML. For example, for the three months ended March 31, 2025, the company estimates an implied utilization rate for its ProVoyance technology of approximately 90%, based on 1,303 surgical plans created using ProVoyance technology and 1,443 implant systems sold during such period. This implied utilization rate is based on real-world data from the company’s customers during such period, as ProVoyance technology tracks and reports each surgical plan that the company’s customers create, and the actual number of implant systems sold during the respective period.
The company has developed a proprietary two-tray instrument system designed to enable interoperability between its aTSA and rTSA systems and a range of humeral stem options. To best support its surgeon customers, the company has built its commercial organization around their unique needs. The company’s commercial organization consists of a dedicated commercial leadership team that drives its internal commercial efforts with an exclusive focus on shoulder care, a CEME team that enhances surgeon engagement and training, and a network of independent distributors. These three key components of the company’s commercial organization work in tandem to form a commercial flywheel that is designed to build and reinforce relationships with surgeons and other stakeholders in the shoulder surgical care market, accelerate adoption, and enhance long-term retention.
The company leverages its team’s decades of experience developing and launching novel shoulder surgical care technologies to identify the unmet needs of patients and surgeons and develop solutions to address those unmet needs. With respect to its advanced implant systems, the company commenced development efforts with its InSet Glenoid in 2009 and received 510(k) clearance in 2011. It commercially launched an initial aTSA system with its InSet Glenoid in 2016. Since this initial launch in 2016, the company has successfully launched a wide range of new technologies to enhance its ecosystem and provide surgeons with the tools and support needed to deliver quality outcomes for patients requiring shoulder surgical care. For example, the company commenced development efforts for its InSet PLUS Augmented Glenoid in 2019 and received 510(k) clearance in 2020. It commenced development efforts for its rTSA system in 2019 and received 510(k) clearance in 2021. The company commenced development efforts for its short stem, stemless, and I-Series humeral stem system options for its aTSA and rTSA systems in 2017, 2019, and 2021, respectively, and received its primary 510(k) clearances in 2018 and 2022, with an additional 510(k) clearance in 2024 for use of its primary I-Series humeral stem for use with anatomic fractures. Each of these devices is classified by the FDA as a Class II device. The company has a robust pipeline of new technologies in various stages of development and evaluation, including the anticipated expansion of its humeral stem line, indication expansions into fracture and revision, and implants tailored for metal-sensitive patients. For example, the company commenced development of InSet 70, InSet 135, and InSet 185 stems to expand its I-Series humeral stem line in 2024, and it anticipates pursuing FDA clearance of these stems, as needed, over the next twelve months. The company is also evaluating expansion into adjacent areas in shoulder surgical care, which may include sports medicine and shoulder trauma markets.
The company has contributed to numerous publications that is evidence and strengthen its position as a leader in shoulder surgical care. A retrospective long-term follow-up analysis of patients who received the company’s InSet Glenoid was published in the Journal of Shoulder and Elbow Surgery in 2019, which demonstrated a 72-point improvement in the mean ASES outcome score, statistically significant improvements in pain scores and range of motion, with no surgical complications, no cases of glenoid loosening, and no revision surgeries performed at a mean follow-up time of 8.7 years. The company is committed to continued investment in obtaining further clinical evidence with the support of surgeons who are recognized as thought leaders in shoulder surgical care.
Growth Strategies
The key elements of the company’s growth strategy are to increase awareness of its purpose-built, innovative shoulder surgical care ecosystem to continue taking share across care settings; expand its commercial flywheel of shoulder specialists, surgeon-to-surgeon collaboration, and network of independent distributors; increase its addressable market through its commitment to continuous innovation and advancing shoulder surgical care; continue building and driving marketing of its technology solutions; and pursue expansion in international markets.
Solutions
Approach to Innovation
The company is building Shoulder Innovations with the goal of addressing some of the most pressing challenges to patient outcomes in shoulder surgical care: poor biomechanical fit, suboptimal kinematics, difficult replacement and conversion procedures (aTSA to rTSA or stemless to stem), imprecise implant positioning, inefficient and burdensome workflow designs, and limitations of a generalist approach. Its innovation-first mentality centers on the patient, realizing that each stakeholder in the care chain is motivated by and benefits from focused and improved patient care. The company seeks to improve core components of shoulder surgical care — preoperative planning, implant design, and procedural efficiency — in an effort to benefit each stakeholder in the care chain.
Key Elements of Ecosystem
The company’s ecosystem consists of the following key elements:
Advanced Implant Systems: The company’s advanced implants include a diverse range of interchangeable InSet aTSA and rTSA systems that leverage its novel, InSet Glenoid and InSet humeral stem technologies.
ProVoyance Preoperative Planning Technology: This preoperative planning technology integrates AI and ML to transform planar CT imaging into 3D renderings, allowing surgeons to create bespoke surgical plans considering patient-specific anatomy ahead of surgery.
Efficient Instrument System: The company’s efficient instrument system supports both aTSA and rTSA procedures from start to finish with just two convenient trays.
Specialized Support: The company’s team of dedicated shoulder specialists enable it to deliver a highly tailored experience to surgeons operating in a complex and technically demanding procedure category.
Surgeon-to-Surgeon Collaboration: The company’s CEME team fosters a collaborative network of expert surgeon educators and promotes surgeon-to-surgeon training and peer education.
Implants Systems
The company developed a comprehensive implant portfolio to address the unique needs of patients and surgeons. Its advanced implants consists of its aTSA and rTSA systems, which include various, specifically designed components capable of a wide array of system configurations to facilitate different modes of operation (anatomic or reverse) that are optimized for patient-specific needs. These systems leverage consistent surgical techniques and the same efficient, two-tray instrumentation system. The design of the company’s advanced implant systems helps to facilitate shoulder surgical care with significant operational flexibility and reduced equipment and operating room footprint requirements.
InSet aTSA System
The company’s aTSA configuration consists of two main components, a glenoid scapular implant and a humeral fixation device, or stem. Each of these components was developed with a view to the overall implant system in an effort to provide maximum benefits to patients and flexibility for surgeons. A retrospective long-term follow-up analysis of patients who underwent aTSA procedures with the company’s InSet Glenoid was published in the Journal of Shoulder and Elbow Surgery in 2019, which demonstrated a 72-point improvement in the mean ASES outcome score, statistically significant improvements in pain scores and range of motion, with no surgical complications, no cases of glenoid loosening, and no revision surgeries performed at a mean follow-up time of 8.7 years.
InSet Glenoid
Unlike traditional glenoid implants that utilize an onlay design, the company’s InSet Glenoid technology features a design that positions the implant within a pocket of sclerotic or cortical bone and aims to reduce mechanical stress at the bone-implant interface, improve fixation mechanics, enhance stability, and reduce micromotion, all of which are key contributors to glenoid loosening. This design also enables a less invasive surgical approach that reduces surgical steps and difficulty of tissue exposure. The company’s InSet Glenoid implants were developed with a patented complex articular surface that contributes to the reduction of the rocking horse motion. The InSet Glenoid design also enables a significantly reduced central fixation peg to provide further surgical flexibility.
The InSet PLUS Augmented Glenoid was designed to treat advanced shoulder conditions in patients with severe bone loss. The design of the InSet PLUS Augmented Glenoid corrects defects on the articular surface (in contrast to the fixation side of the implant) with five or ten-degree options. This method allows surgeons to easily adjust the implant’s position for optimal patient fit and stability through this dialable and articular side augmentation.
Supported by a growing body of peer-reviewed studies and approximately nine years of published data, the company’s InSet Glenoid technology has demonstrated effectiveness across a variety of clinical indications, including cases involving advanced arthritis and severe bone loss. In addition to preserving bone in patients, the company’s InSet Glenoid technology has been shown to facilitate quick recovery times, decreased pain, and improved range of motion for patients after surgery.
The company commenced development efforts with its InSet Glenoid in 2009 and received 510(k) clearance in 2011. It commercially launched an initial aTSA system with its InSet Glenoid in 2016. The company commenced development efforts for its InSet PLUS Augmented Glenoid in 2019 and received 510(k) clearance in 2020. Each of these devices is classified by the FDA as a Class II device.
InSet Humeral Stems
The company offers three unique InSet humeral stem system options for its aTSA and rTSA systems—Humeral Stemless, Humeral Short Stem, and I-Series Humeral Stem—each purpose-built to address the specific needs of patients and physicians. The company’s humeral stems feature a proprietary porous coating designed to promote bone ingrowth by allowing bone tissue to grow into the porous structure (osseointegration), which creates a strong natural biological fixation and improves implant stability.
The company commenced development efforts for its short stem, stemless, and I-Series humeral stem system options for its aTSA and rTSA systems in 2017, 2019, and 2021, respectively, and received its primary 510(k) clearances in 2018 and 2022, with an additional 510(k) clearance in 2024 for use of the InSet 95 stem for use with anatomic fractures. Each of these devices is classified by the FDA as a Class II device.
The company’s novel humeral stem solutions are differentiated and designed to be compatible across the full range of its implant systems. Surgery with each humeral stem involves a consistent surgical technique and instruments, which enables seamless interchangeability between its aTSA and rTSA systems. This interchangeability is important in cases where the surgeon makes an intraoperative decision to switch from a stemless to a stemmed implant, or in revision or conversion surgeries where the determination is made to switch to a different implant modality (anatomic or reverse) or alternative humeral stem design.
InSet rTSA System
The company’s rTSA configuration leverages the same humeral fixation platform as its aTSA configuration but utilizes alternative humeral and glenoid articular components designed for the reverse modality. The humeral component is configured to allow attachment of a tray and bearing assembly, designed to articulate with the glenoid sphere (glenosphere). The glenosphere is attached to a baseplate configured to provide reliable fixation to the glenoid on the scapular bone.
The company’s rTSA system was designed to optimize biomechanics and provide patients and physicians with a novel reverse implant solution that functions more like an anatomic implant in terms of improved range of motion. The InSet design of the company’s rTSA system allows for retention of the patient’s native anatomy and aesthetic and helps to achieve desirable, impingement-free range of motion by avoiding arm lengthening, overstuffing, and other common challenges.
Humeral Tray and Bearing Assembly
The company’s humeral tray and bearing assembly are comprised of two components—a titanium humeral tray and a polyethylene bearing—designed for low-profile assembly using its proprietary Twistlock locking mechanism. The Twistlock mechanism improves bearing-to-tray pullout strength, reducing the potential for bearing disassociation, a serious complication in rTSA where the polyethylene liner (socket) separates from the humeral tray (ball).
The company’s humeral tray and bearing assembly feature a unique bowl-shaped design that, together with the low-profile nature of the Twistlock design, allows for inlay biomechanics with an rTSA modality, in which the apex of the glenosphere is positioned on the articular surface. This tray and bearing assembly, a key component of the company’s rTSA system, connects to its humeral stems in the same manner as the company’s InSet humeral head solutions, a key component of its aTSA system. The identical connection mechanism between these key components of the company’s aTSA and rTSA systems is a critical design feature that enables the interchangeability of its systems and the potential for the humeral stem to remain in place during a revision or conversion surgery.
Scapular Reverse Assembly
The scapular assembly for rTSA consists of two main components—a baseplate and a glenosphere—assembled by attaching the baseplate to the scapula using peripheral and central screws, then connecting the glenosphere to the baseplate using the company’s proprietary locking cap technology. The company has developed a wide range of baseplate and glenosphere options, which allows for multiple configurations to support a broad range of patient anatomy. With the use of ProVoyance, the assembly is configured to a patient’s unique needs. This assembly enables a lateralized center of rotation that, together with the company’s humeral assembly, results in a reverse implant that feels and functions more like an anatomic shoulder replacement, with optimized range of motion and joint stability.
The company commenced development efforts for its rTSA system in 2019 and received 510(k) clearance in 2021. The rTSA system is classified by the FDA as a Class II device.
ProVoyance Preoperative Planning Technology
The company offers a highly approachable, easy-to-use preoperative planning technology with an intuitive interface designed to engage surgeons at levels that are industry-leading.
ProVoyance integrates AI and ML to transform planar CT imaging into 3D renderings of patient-specific anatomy ahead of surgery. Its AI and ML algorithms empower surgeons to independently create bespoke surgical plans that can help ensure consistent, effective positioning of the company's implants.
ProVoyance received 510(k) clearance from the FDA in 2021 and is classified by the FDA as a Class II device. ProVoyance is listed on the FDA’s AI/ML-enabled medical devices list, which is a resource maintained, published, and periodically updated by the FDA to identify AI/ML-enabled devices that have been authorized for marketing in the United States through any of the standard paths to market for medical devices, although it is not intended to be a comprehensive list of all such devices that incorporate AI/ML. This is highly differentiated from other preoperative planning solutions, where the implant manufacturer or another third party creates a surgical plan that is sent to the surgeon for their consideration.
For the three months ended March 31, 2025, the company estimates an implied utilization rate for its ProVoyance technology of approximately 90%, based on 1,303 surgical plans created using ProVoyance technology and 1,443 implant systems sold during such period. This implied utilization rate is based on real-world data from the company's customers during such period, as ProVoyance technology tracks and reports each surgical plan that the company’s customers create, and the actual number of implant systems sold during the respective period. ProVoyance delivers true full-depth 3D rendering, 2D/3D bone density analysis, and biplanar glenoid deformity correction. ProVoyance provides an enhanced preoperative planning experience for surgeons and allows them to approach procedures with high confidence in their surgical plan.
Efficient Instrument System
The company re-engineered the components and technique for shoulder arthroplasty in order to create its proprietary InSet instrument system. This system was designed to enable interoperability between the company's novel aTSA and rTSA systems and a range of humeral stem options, while minimizing complexity and streamlining workflows.
The instrument system consists of many components that fit within two trays, which have been specifically designed to facilitate the surgical technique used in connection with the company's implant systems. The components of each tray were designed for the company’s implant characteristics and function. For example, the shape of the fixation fins on the humeral components were specifically designed to facilitate a surgical technique that can be used across procedure types and systems, and each instrument was designed with a view to maximize utility and reduce the overall quantity of instruments used in procedures involving the company's systems.
Commercial Approach
The company views itself as specialists serving specialists, having purposefully built its commercial organization around the unique needs of shoulder surgeons. The commercial organization consists of three key components: a dedicated commercial leadership team, a CEME team, and a network of independent distributors. These key components work in tandem to form a commercial flywheel that is designed to build and reinforce relationships with surgeons and other stakeholders in the shoulder surgical care market, accelerate adoption, and enhance long-term retention.
The company estimates that approximately 15,000 surgeons in the United States perform at least one shoulder arthroplasty procedure per year, with approximately 1,800 high-volume surgeons performing the vast majority of procedures. To optimize its commercial strategy, the company has developed proprietary business intelligence tools that enable it to identify and engage with the high-volume surgeons most likely to adopt its solutions. These tools analyze key data points such as surgeon location, procedure mix, and care settings, enabling the company to prioritize outreach and allocate commercial resources efficiently. By understanding where and how these high-volume surgeons practice, the company can tailor its engagement strategies to align with their clinical and operational needs.
Once a surgeon is integrated into the company's ecosystem, it focuses on expanding utilization by increasing the percentage of procedures performed with its solutions. To support targeting and commercial efforts, the company has classified surgeon customers into three categories: prospect surgeons, who perform between one and two shoulder arthroplasty procedures using the company's implant systems per quarter; contender surgeons, who perform between three and eight shoulder arthroplasty procedures using the company's implant systems per quarter; and core surgeons, who perform at least nine shoulder arthroplasty procedures using the company's implant systems per quarter. A key driver of increasing adoption within the existing surgeon base over time (helping prospect surgeons become contender surgeons, and contender surgeons to become core surgeons) is the company’s surgeon-to-surgeon education program facilitated by its CEME team. The company is committed to fostering a collaborative community among shoulder surgeons where expertise is shared, new ideas are exchanged, and best practices are disseminated to enhance clinical outcomes. By facilitating these peer connections, the company strengthens engagement within its ecosystem and reinforces its real-world success.
Product Development and Pipeline
The company leverages its team’s decades of collective experience developing and launching novel shoulder surgical care technologies to identify solutions addressing the unmet needs of patients and surgeons. Since the initial launch of its InSet Glenoid in 2016, the company has successfully commercialized a wide range of new technologies to enhance its ecosystem and provide surgeons with the tools and support needed to deliver quality outcomes for patients requiring shoulder surgical care.
The company continues to see clinical outcomes in the shoulder surgical care space that are inferior to those seen in more mature orthopedic markets and intends to continue working with its surgeon advisors to further improve clinical outcomes in shoulder surgical care. The company has a robust pipeline of new technologies in various stages of development and evaluation, including the following select projects.
I-Series Expansion and New Indications
The company engineered the I-Series humeral stem line to provide a novel stem option for patients suffering from arthritis and a wide spectrum of proximal humeral bone loss or density. The I-Series humeral stems feature a 2-fin design, specifically engineered for superior rotational control and stability. The company launched its initial I-Series system in 2023, the InSet 95 Humeral Stem, which has been well received by the marketplace. The company is developing additional stems, including InSet 70, InSet 135, and InSet 185 stems to expand its I-Series humeral stem line. Development efforts for these additional InSet 70, InSet 135, and InSet 185 stems commenced in 2024, and the company anticipates pursuing FDA clearance of these stems, as needed, over the next twelve months. These additional clearances, if received from the FDA, will extend the range of available stem sizes and include expanded indications into fracture and revision surgeries.
Technologies for Metal Hypersensitive Patients
Market awareness of the risks and prevalence of metal hypersensitivity has risen in recent years. The company is developing a line of humeral head and glenoid technologies for the approximately 10% to 15% of the general population who test positively for a metal hypersensitivity and may experience persistent pain or other symptoms associated with allergic reactions from metal implants. These development technologies include the Humeral Head and Glenosphere, each constructed from alternative materials that do not incorporate elements that typically represent higher allergic risk for patients who test positively for a metal hypersensitivity. The company anticipates pursuing FDA clearance of these solutions over the next twelve months.
Adjacent Market Expansion
The company is also evaluating expansion into adjacent areas in shoulder surgical care, which may include sports medicine and shoulder trauma markets.
Coverage and Reimbursement
The company sells its systems directly to hospitals, outpatient care centers, and ASCs. These customers, in turn, bill various third-party payors, such as Medicare, Medicaid, and private health insurance plans, for the total healthcare services required to treat the patient. Government agencies, private insurers, and other payors determine whether to provide coverage for a particular procedure and to reimburse hospitals, outpatient care centers, and ASCs at rates based on a prospective payment system. For procedures performed during a hospital inpatient stay, Medicare generally reimburses hospitals a single bundled payment that is based on the patient’s principal diagnosis, up to 24 additional diagnoses, and up to 25 procedures performed during the stay. Cases are classified into Medicare Severity-Diagnosis Related Groups (MS-DRGs), for payment under the Medicare Inpatient Prospective Payment System, for all items and services provided to the patient during a single hospitalization, regardless of whether procedures utilizing the company’s products are performed during such hospitalization. Medicare rates for the same or similar procedures vary due to geographic location, the nature of the facility in which the procedure is performed, and other factors. With respect to procedures performed in a hospital outpatient setting, all items and services paid under the Medicare outpatient prospective payment system are assigned to payment groups called Ambulatory Payment Classifications, which group together items and services that are similar clinically and in terms of resource use. With respect to ASCs, covered procedures are assigned to ASC payment groups, which then determines the amount that Medicare pays for facility services furnished in connection with a covered procedure. Effective January 1, 2024, CMS added total shoulder arthroplasty to the list of covered procedures that can be performed in ASCs, which facilitated reimbursement and further supported the growth of ASCs as a key site of care in the shoulder surgical care market.
Intellectual Property
The company is seeking and maintaining patent protection in the United States and key foreign jurisdictions where it intends to market its products, and plans to do so with respect to any of its future product candidates. The company's patent portfolio includes a combination of patents and pending patent applications solely held by it.
As of May 16, 2025, the company's owned patent estate contains eleven (11) patent families comprising eleven (11) issued U.S. patents, seven (7) issued foreign patents, eleven (11) pending U.S. non-provisional patent applications, and twenty (20) pending foreign patent applications. The eleven (11) issued U.S. patents are expected to expire between April 2025 and October 2041, after accounting for potentially available patent term adjustments, and assuming payment of appropriate maintenance, renewal, annuity, and other governmental fees. Any patents that may issue from the eleven (11) pending U.S. patent applications are expected to expire between March 2030 and January 2045, without accounting for potentially available patent term adjustments, term-limiting effects of terminal disclaimers, and assuming payment of appropriate maintenance, renewal, annuity, and other governmental fees. The seven (7) issued foreign patents include one or more issued patents in jurisdictions such as Australia, Canada, and Europe (validated in one or more of Germany, France, Switzerland, and the U.K. and/or as having unitary effect), and are expected to expire between February 2026 and April 2039, without accounting for potentially available patent term extensions and assuming payment of appropriate maintenance, renewal, annuity, and other governmental fees. The twenty (20) pending foreign patent applications include one or more pending applications in jurisdictions such as Australia, China, Europe, and Japan, and are expected to expire between April 2038 and March 2044, without accounting for potentially available patent term extensions and assuming payment of appropriate maintenance, renewal, annuity, and other governmental fees. Calculation of the expiration of issued patents is complex, varies by country, and is based upon many factors. Accordingly, the following expiration dates are estimates.
The company's owned U.S. and foreign patents and patent applications generally relate to anatomic total shoulder arthroplasty, reverse total shoulder arthroplasty, and instrumentation systems for anatomic total shoulder arthroplasty and reverse total shoulder arthroplasty. The company's owned issued U.S. and foreign patents are set forth in the table below, which are directed to its relevant technologies, including glenoid implants, humeral implants, reverse shoulder replacement systems, and instrumentation for shoulder replacement.
Software License Agreement with Genesis Software
On October 22, 2020, the company entered into a software license agreement with Genesis Software, which was amended and restated on January 1, 2023, and subsequently amended and restated on June 10, 2025 (as amended and restated, the License Agreement). Pursuant to the License Agreement, Genesis Software granted the company an exclusive, worldwide, transferable, sublicensable, and royalty-bearing license under Genesis Software’s SaaS surgery planning platform software, including all intellectual property rights therein, updates, upgrades, and other modifications thereto, and object code, source code, and other surgery planning software developed or controlled by Genesis Software during the term of the License Agreement (collectively, the Licensed Software), to store, use, copy, make derivative works from, modify, extend, enhance, and improve the Licensed Software in the field of shoulder surgical procedures primarily related to the replacement of the shoulder joint articulation (i.e., anatomic shoulder arthroplasty, reverse shoulder arthroplasty, revision shoulder arthroplasty, and hemi-shoulder arthroplasty) (the Field of Use). The Licensed Software is utilized in connection with ProVoyance. The company granted Genesis Software a limited, non-exclusive, non-transferable license to use data generated by the company through its use of the Licensed Software solely in connection with the customization of an implant or other software products outside the Field of Use. Genesis Software granted the company a limited, non-exclusive, non-transferable license under identified data collected by Genesis Software through its use of the Licensed Software outside of the Field of Use for the company's use within the Field of Use. The company also agreed to compensate Genesis Software for certain development, consulting, and support services related to the Licensed Software that it may request from time to time.
Manufacturing and Supply
For example, Avalign Technologies manufactures and supplies the company’s humeral stems, Micropulse is the company's sole source for Inset Glenoid, Trifecta Medical Group manufactures and supplies the company’s trays, and RMD supplies surgical instruments used during procedures involving the company’s systems. The company also utilizes a single supplier for the significant majority of its sterilization needs.
The company’s third-party manufacturing and supply providers are evaluated, qualified, and approved through its supplier quality program, which includes verification and monitoring procedures to help ensure that its suppliers comply with FDA and ISO standards, as well as the company's own specifications and requirements.
Competition
The company competes with Arthrex, Enovis, Exectech, Johnson & Johnson, Smith & Nephew, Stryker, and Zimmer Biomet. Furthermore, conditions in the company’s market could change rapidly and significantly as a result of technological advancements, partnerships, or acquisitions by competitors. The company has seen and continues to see consolidation among its competitors.
Government Regulation
The company’s products and operations are subject to extensive regulation by the FDA and other federal and state authorities in the United States. The company’s products are subject to regulation as medical devices in the United States under the Federal Food, Drug and Cosmetic Act (FDCA), as implemented and enforced by the FDA.
History
Shoulder Innovations, Inc. was incorporated in 2009.
