The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

significant disability in degenerative, rheumatic disease of the glenohumeral joint;
avascular necrosis of the humeral head.

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

The 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.

Device Description

The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads that articulate with a glenoid component. The humeral stems are collarless and manufactured from Titanium Alloy (Ti6-4) with fins to provide rotational stability. The collarless stems allow the humeral head to prevent stem subsidence. The stems have a female Morse-type taper to interface with the modular humeral heads. The proximal body and fins are coated with a rough, porous coating for un-cemented fixation or for use with bone cement.

The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems.

The glenoid components of the Total Shoulder System are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implant is a multi-pegged design intended for cemented fixation only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Shoulder Innovations Total Shoulder System, and specifically a line extension to add "Augmented Glenoids." This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving a device meets specific acceptance criteria based on performance data.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted from this type of regulatory submission. The document relies on non-clinical testing and comparison to predicate devices to demonstrate substantial equivalence, not a clinical study with detailed performance metrics against predefined acceptance criteria.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document in the format of a typical acceptance criteria table with performance results. The document explains that non-clinical testing was performed according to ASTM F2028-17 and cadaver testing, and these tests "demonstrated that the Augmented Glenoids are adequate for their intended use." However, specific numerical acceptance criteria and performance values are not reported.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated for the non-clinical tests. For cadaver testing, a sample size is typically provided, but it's absent here.
Data Provenance: The cadaver testing is generally considered prospective in its data collection for the specific purpose of the study. The location of testing or origin of cadavers is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the document describes non-clinical and cadaveric testing, not a study evaluating human interpretation or diagnosis where expert ground truth would be established.

4. Adjudication method for the test set

This is not applicable for the same reasons as #3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an orthopedic implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is an orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests (ASTM F2028-17 and cadaver testing), the "ground truth" would be the physical measurements and observations from the tests themselves, demonstrating mechanical properties or performance under simulated conditions. This is not "expert consensus, pathology, or outcomes data" in the typical sense for a clinical study.

8. The sample size for the training set

This is not applicable. The document describes a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as #8.

Summary

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November 29, 2019

Shoulder Innovations Inc Don Running VP R&D 13827 Port Sheldon Street HOLLAND, MI 49424

Re: K192365

Trade/Device Name: Shoulder Innovations Total Shoulder System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder Joint Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWT, KWS, MBF, HSD Dated: October 25, 2019 Received: November 1, 2019

Dear Don Running:

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 (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 located 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Michael Owens Acting 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

510(k) Number (if known) K192365

Device Name

Shoulder Innovations Total Shoulder System

Indications for Use (Describe)

The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

significant disability in degenerative, rheumatic disease of the glenohumeral joint; 2. avascular necrosis of the humeral head.

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

The 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.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared:	August 27, 2019
Submitter:	Shoulder Innovations13827 Port Sheldon St.Holland, MI 49424
Contact:	Don RunningVice President – R&DShoulder Innovations(574) 253-1133don@genesisinnovationgroup.com
Proprietary Name:	Shoulder Innovations Total Shoulder System
Common Name:	Shoulder Prosthesis
Classification:	21 CFR Section 888.3650 – Shoulder joint metal/polymer non-constrained cemented prosthesis; Class IIProduct Code: KWT21 CFR Section 888.3660 – Shoulder joint metal/polymersemi-constrained cemented prosthesis; Class IIProduct Code: KWS21 CFR Section 888.3670 – Shoulder jointmetal/polymer/metal nonconstrained or semi-constrainedporous-coated uncemented prosthesis; Class IIProduct Code: MBF21 CFR Section 888.3690 – Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis; Class IIProduct Code: HSD
SubstantiallyEquivalent Devices:	K111596 – Shoulder Innovations Total Shoulder System(glenoid modification)K173824 - Shoulder Innovations Humeral Short Stem System(humeral modification)
Reference Device:	K121220 – Exactech Equinoxe UHMWPE 16° PosteriorAugmented Pegged Glenoids

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Intended Use / Indications:

The Shoulder Innovations Total Shoulder System 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;
1. avascular necrosis of the humeral head.

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

The 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.

The indications for use are unchanged from K173824 for the Total Shoulder System.

Device Description:

The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems.

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Proposed Modification:

The subject of this submission is a line extension to add the Augmented Glenoids to the Shoulder Innovations Total Shoulder System. The Augmented Glenoids are almost identical to the previously cleared glenoid component (K111596) except for an angled articular surface, creating the augmented glenoid. The Augmented Glenoids are available in both 5° and 10° variants. The Augmented Glenoids are manufactured from UHMWPE conforming to ASTM F648, which is the same material as the previously cleared glenoid components, utilizing the same manufacturing processes. The Augmented Glenoids are available in multiple widths.

All Shoulder Innovations Total Shoulder System Augmented Glenoids are compatible with the previously cleared Total Shoulder System humeral components (K102670 and K173824).

Non-Clinical Testing:

The Augmented Glenoids were evaluated to demonstrate substantial equivalence to the predicate devices. Testing was performed in accordance with ASTM F2028-17, Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation. Cadaver testing of the Augmented Glenoids was also performed. The test results demonstrated that the Augmented Glenoids are adequate for their intended use.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the Shoulder Innovations Total Shoulder System Augmented Glenoids to the predicate devices.

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Predicate Device Comparison:

Property or Characteristic	Shoulder InnovationsTotal Shoulder SystemGlenoid Component(K111596)	Shoulder Innovations TotalShoulder System AugmentedGlenoids(Current Submission)
Material	UHMWPE	Same as K111596
Articulating Surface Geometry	Concave with modified radiusof curvature	Same as K111596
Minimum Poly Thickness	3.3 mm	Same as K111596
Perimeter Geometry	Ellipse with sides trimmed atan acute angle	Ellipse with sides trimmedparallel
Angle of articular surface	None	5° or 10°
Provided Sterile	Yes	Same as K111596
Fixation Method	Cemented Only	Same as K111596

Summary of Technologies / Substantial Equivalence:

The Shoulder Innovations Augmented Glenoids are substantially equivalent to the Shoulder Innovations Total Shoulder System glenoid components in regard to indications for use, material and design. The angling of the articular surface of the glenoid to create the Augmented Glenoids does not raise new questions in regard to safety and effectiveness of the device, nor are there new technological issues.

Regulation Number and Section

§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.

(a)
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).(b)
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.”