The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

Device Description

The Exactech Equinoxe Small Reverse Shoulder is a subsystem of the Exactech Equinoxe Reverse Shoulder System which provides small reverse glenoid plates, small reverse glenospheres, screw components, humeral liners, and surgical instrumentation for use in reverse total shoulder arthroplasty. The modifications proposed by this submission describe minor geometry changes to the predicate Exactech Equinoxe Small Reverse Shoulder Glenospheres and Humeral Liners. As well as minor geometry modifications, this submission proposes Equinoxe Locking Cap compatibility with the Small Reverse Glenoid Plates and Small Reverse Glenospheres.

AI/ML Overview

This document describes the Exactech Equinoxe Small Reverse Shoulder Glenospheres and Humeral Liners. The submission is a "Special 510(k)", which implies that minor changes have been made to a previously cleared device. Therefore, the "study" described focuses on demonstrating that these minor changes do not alter the substantial equivalence to the predicate device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Maintenance of mechanical and dimensional properties after minor geometry changes.	Engineering analyses (TM-2018-0755, TR-2018-0720, TM-2018-0523) demonstrated that the mechanical and dimensional properties of the modified glenospheres and humeral liners, as well as the compatibility with the Equinoxe Locking Cap, are maintained and within acceptable tolerances. These analyses provided justification for the internal bore modification, tolerance analysis, and undercut geometry update.
Sterility (Pyrogenicity)	Pyrogen testing (in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72) confirmed that the proposed components meet recommended limits for devices labeled as sterile.
Substantial Equivalence to Predicate Device	Based on the engineering analyses, the proposed devices (Small Reverse Glenosphere and Humeral Liner) were deemed substantially equivalent to the cleared predicate Equinoxe Small Reverse Glenosphere and Humeral Liner devices. This equivalence is supported by identical indications for use, intended use, device materials, design features, basic scientific technology, and implant/instrument compatibility.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the traditional sense of a clinical or in-vitro study with a distinct test set of data. The "test set" here refers to the specific design modifications and components that underwent engineering analysis and pyrogen testing.
Data Provenance: The data provenance is internal to Exactech, Inc., as the tests and analyses were conducted by the manufacturer for their device modifications. The information is retrospective in terms of being generated to support the specific 510(k) submission for changes to an existing product. No external or prospective data is mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission relies on engineering analyses and standardized pyrogen testing, not expert consensus on diagnostic images or clinical outcomes. The "ground truth" for the engineering analyses is based on established mechanical principles, material science, and design specifications. For pyrogen testing, the ground truth is defined by the standards (USP <161>, USP <85>, ANSI/AAMI ST72).

4. Adjudication Method for the Test Set

Not applicable. No clinical or expert review adjudication was performed for these engineering and sterility tests. The evaluation is based on meeting pre-defined engineering tolerances and standard test limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This is a submission for a modification to a medical device (implants), not an AI or diagnostic imaging device that would typically involve human readers.

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

Not applicable. This device is a physical implant for shoulder arthroplasty, not an algorithm or software. "Standalone" performance is not a relevant concept here.

7. The Type of Ground Truth Used

The ground truth used in this submission is based on:

Engineering specifications and tolerances: for the mechanical and dimensional properties.
Established industry standards: for pyrogen testing (USP <161>, USP <85>, ANSI/AAMI ST72).

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of device modification submission. Device design and engineering are not typically "trained" in the machine learning sense.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set.

Summary

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October 12, 2018

Exactech, Inc. Zach Sharrah Senior Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653

Re: K182536

Trade/Device Name: Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, KWT, KWT, KWS Dated: September 13, 2018 Received: September 14, 2018

Dear Zach Sharrah:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

VesaVuniqi -S	Digitally signedby Vesa Vuniqi -SDate: 2018.10.1215:21:00 -04'00'
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Mark N. Melkerson For: Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182536

Device Name

Exactech® Equinoxe® Small Reverse Glenospheres and Humeral Liners

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Exactech® Equinoxe® Small Reverse Glenospheres and Humeral Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness

Sponsor:	Exactech®, Inc.2320 NW 66th CourtGainesville FL, 32653
	Phone: (352) 377-1140Fax: (352) 378-2617
	FDA Establishment Number 1038671
Contact Person:	Zach SharrahSenior Regulatory Affairs SpecialistTelephone: (352) 377-1140Fax: (352) 378-2617
Date:	September 13, 2018
Proprietary Name:	Exactech® Equinoxe® Small Reverse Glenospheres andHumeral Liners
Common Name:	Reverse Shoulder Arthroplasty

Classification Name:

Shoulder Prosthesis, Reverse Configuration (21 CFR Section 888.3660, Class II, Product Code PHX
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer cemented (21 CFR ● Section 888.3650, Class II, Product Code KWT
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer cemented (21 ● CFR Section 888.3660, Class II, Product Code KWS

Legally Marketed Device to Which Substantial Equivalence Is Claimed:

Name	Manufacturer	510(k) Number
Equinoxe Small Reverse Shoulder System	Exactech, Inc.	K180632
Equinoxe Reverse Shoulder	Exactech, Inc.	K063569

Indications for Use:

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Exactech® Equinoxe® Small Reverse Glenospheres and Humeral Liners Special 510(k) - 510(k) Summary of Safety and Effectiveness

Device Description:

Both the proposed and predicate devices share the following similarities:

Identical Indications for Use ●
0 Identical intended use
Identical device materials ●
The same design features and basic fundamental scientific technology ●
The same implant and instrument compatibility o

Non-Clinical Testing:

Engineering and tolerance analyses were conducted to evaluate the mechanical and dimensional properties of the Exactech Equinoxe Small Reverse Glenospheres and Equinoxe Locking Cap compatibility:

TM-2018-0755 - Justification for the Equinoxe Small Reverse Shoulder Glenosphere Internal Bore Modification and Standard Locking Cap Compatibility
TR-2018-0720 Equinoxe Small Reverse Shoulder Glenosphere, ● Glenosphere Trial, and Locking Cap Tolerance Analysis
TM-2018-0523 Justification for the Humeral Liner Undercut Geometry ● Tolerance Update

Pyrogen testing was conducted in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72 to ensure the proposed Equinoxe Small Reverse Shoulder components meet recommended limits per FDA's Guidance Document Submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile.

Substantial Equivalence Conclusion:

Results of the engineering analyses referenced in this 510(k) submission demonstrate the proposed Equinoxe Small Reverse Glenosphere and Humeral Liner devices are substantially equivalent to the cited cleared predicate Equinoxe Small Reverse Glenosphere and Humeral Liner devices.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing 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 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”