N22 Offset Humeral Head

K262173 · Shoulder Innovations, Inc. · KWT · Sep 8, 2026 · Orthopedic

Device Facts

• Record ID: K262173
• Device Name: N22 Offset Humeral Head
• Applicant: Shoulder Innovations, Inc.
• Product Code: KWT · Orthopedic
• Decision Date: Sep 8, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3650
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Shoulder Innovation's InSet Total Shoulder System, when used with the InSet Stem, is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following: 1. Significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint. 2. Fractures of the humeral head 3. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 4. Avascular necrosis of the humeral head 5. Revision where other devices or treatments have failed. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. The InSet Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation. N22 Offset Humeral Head made of Titanium is indicated for patients with a suspected sensitivity to the constituents of CoCr alloy that complies with ASTM F75. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Cobalt Alloy humeral head is the recommended component for anatomic shoulder arthroplasty patients without material sensitivity to the constituents of CoCr alloy.

Device Story

N22 Offset Humeral Head is a modular orthopedic implant component for the InSet Total Shoulder System; used in partial or total shoulder arthroplasty. Device replaces damaged humeral head; provides articulating surface for glenoid component or natural glenoid. Operated by orthopedic surgeons in clinical/OR settings. Input is patient anatomy; output is mechanical joint replacement. Titanium alloy construction provides alternative for patients with CoCr sensitivity. Device utilizes Morse-type taper for modular connection to humeral stem. Benefits include restoration of joint function and compatibility with existing InSet system for patients with metal allergies.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical testing including biocompatibility, cleaning, sterilization, shelf-life, axial displacement (taper integrity), material mechanical properties, and range of motion analysis.

Technological Characteristics

Modular humeral head; material: Titanium alloy (Ti-6Al-4V per ASTM F136) with nitrogen ion implantation surface hardening. Connection: Morse-type taper. Dimensions: multiple diameters/heights. Sterilization: not specified. Connectivity: N/A. Software: N/A.

Indications for Use

Indicated for adults (22+) requiring partial or total shoulder arthroplasty due to degenerative, rheumatoid, or traumatic glenohumeral disease, humeral head fractures, proximal humerus fractures, avascular necrosis, or revision. N22 Titanium version specifically indicated for patients with suspected sensitivity to CoCr alloy constituents.

Regulatory Classification

Identification

A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,” (vii) F 1378-97 “Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• Shoulder Innovations Inset Total Shoulder System (K241817)

Reference Devices

• Identity Shoulder System (K213856)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

September 8, 2026

Shoulder Innovations, Inc.
Mark Hanes
Senior Technical Director
1535 Steele Ave. SW
Suite B
Grand Rapids, Michigan 49507

Re: K262173

Trade/Device Name: N22 Offset Humeral Head

Regulation Number: 21 CFR 888.3650

Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis

Regulatory Class: Class II

Product Code: KWT, KWS, HSD

Dated: June 26, 2026

Received: June 26, 2026

Dear Mark Hanes:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K262173 - Mark Hanes

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# FARZANA SHARMIN -S

Farzana Sharmin, PhD

Assistant Director

DHT6A: Division of Joint Arthroplasty Devices

OHT6: Office of Orthopedic Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262173 | ? |
| Please provide the device trade name(s). | | ? |
| N22 Offset Humeral Head | | |
| Please provide your Indications for Use below. | | ? |
| The Shoulder Innovation's InSet Total Shoulder System, when used with the InSet Stem, is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following: | | |
| 1. Significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint. 2. Fractures of the humeral head 3. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 4. Avascular necrosis of the humeral head 5. Revision where other devices or treatments have failed. | | |
| The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. | | |
| The InSet Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation. | | |
| N22 Offset Humeral Head made of Titanium is indicated for patients with a suspected sensitivity to the constituents of CoCr alloy that complies with ASTM F75. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Cobalt Alloy humeral head is the recommended component for anatomic shoulder arthroplasty patients without material sensitivity to the constituents of CoCr alloy. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |

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SHOULDER
INNOVATIONS

K262173 - Page 1 of 3

### 510(k) Summary

| Date Prepared: | June 25, 2026 |
| --- | --- |
| Submitter: | Shoulder Innovations, Inc. 1535 Steele Ave SW, Suite B Grand Rapids, MI 49507 |
| Contact: | Dr. Mark D. Hanes, Ph.D. Sr. Technical Director Shoulder Innovations, Inc. [phone] [e-mail] |
| Proprietary Name: | N22 Offset Humeral Head |
| Common Name: | Shoulder Prosthesis |
| Classification Name: | Shoulder Joint Metal/Polymer Non-Constrained Cemented Prosthesis |
| Regulation Number: | 21 CFR 888.3650 |
| Classification Code: | KWT, KWS, HSD |
| Review Panel: | Orthopedic |
| Predicate Devices: | Primary Predicate K241817 – Shoulder Innovations Inset Total Shoulder System Reference Device K213856 – Identity Shoulder System |

### Device Description:

The subject device is the N22 Offset Humeral Head, a modular humeral head component intended for use with the Shoulder Innovations InSet™ Total Shoulder System (K241817). The N22 Offset Humeral Head is manufactured from titanium alloy (Ti-6Al-4V) per F136 featuring nitrogen ion implantation surface hardening treatment. The device is available in multiple diameters and heights and utilizes the same Morse-type taper connection, geometry, articulation profile, and system compatibility as the cleared cobalt chromium (CoCr) humeral head component of the InSet™ Total Shoulder System. The N22 Offset Humeral Head is intended for use in patients with a known or suspected sensitivity to the constituents of cobalt chromium alloy.

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SHOULDER
INNOVATIONS

K262173 - Page 2 of 3

### Indications for Use:

The Shoulder Innovation's InSet Total Shoulder System, when used with the InSet Stem, is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

1. Significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
2. Fractures of the humeral head
3. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
4. Avascular necrosis of the humeral head
5. Revision where other devices or treatments have failed.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.

The InSet Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.

N22 Offset Humeral Head made of Titanium is indicated for patients with a suspected sensitivity to the constituents of CoCr alloy that complies with ASTM F75. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloys. A Cobalt Alloy humeral head is the recommended component for anatomic shoulder arthroplasty patients without material sensitivity to the constituents of CoCr alloy.

### Substantial Equivalence Discussion

The N22 Offset Humeral Head is substantially equivalent to the humeral head component of the InSet™ Total Shoulder System (K241817) in that both devices have the same intended use, design, geometry, modular Morse taper connection, articulation function, and compatibility with the InSet™ Total Shoulder System. Both devices are intended for use as humeral head components in shoulder arthroplasty procedures.

The primary technological difference is the use of Titanium Alloy (Ti-6Al-4V per ASTM F136) in the subject device compared to cobalt chromium alloy in the predicate device. Similar titanium humeral head technology has been previously cleared for use in shoulder arthroplasty applications. The material characteristics of the subject device were evaluated through appropriate non-clinical testing and biocompatibility assessment. These differences do not alter the intended use or fundamental scientific technology of the device and do not raise new questions about safety or effectiveness.

### Non-Clinical Testing Summary:

The N22 Offset Humeral Head was evaluated to demonstrate substantial equivalence to the predicate device. Non-clinical testing included biocompatibility evaluation, cleaning validation, sterilization validation, shelf-life validation, axial displacement (taper integrity) testing, evaluation of material mechanical properties, and range of motion analysis.

### Clinical Testing Summary:

Clinical testing was not necessary to demonstrate substantial equivalence of the N22 Offset Humeral Head to the predicate device.

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SHOULDER
INNOVATIONS

K262173 - Page 3 of 3

## Overall Conclusion:

The proposed subject device has the same intended use and indications for use as the predicate device. Non-clinical evaluation demonstrated that subject device is substantially equivalent to the legally marketed predicate device. The proposed device has similar technological characteristics to the predicate, and the information provided herein demonstrates that:

- any differences do not raise different questions of safety and effectiveness; and
- proposed device is as safe and effective as the legally marketed predicate device.