The Equinoxe Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.

Clinical indications for the PRIMARY (P), LONG/REVISION (L/R) and FRACTURE (F) humeral components are as follows:
P, L/R: rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
P, L/R: congenital abnormalities in the skeletally mature
P: primary and secondary necrosis of the humeral head.
P, F: humeral head fracture with displacement of the tuberosities
P, L/R: pathologies where arthodesis or resectional arthroplasty of the humeral head are not acceptable
P, L/R: revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
F: displaced three-part and four-part upper humeral fractures
L/R: spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
L/R: revision of failed previous reconstructions when distal anchorage is required
P, L/R: to restore mobility from previous procedures (e.g. previous fusion)

Device Description

The EQUINOXE® Shoulder System comprises both cemented and press-fit semiconstrained glenohumeral prostheses for use in hemi-shoulder and total-shoulder joint replacement procedures and a cemented semi-constrained glenohumeral fracture prosthesis for use in fractures of the proximal humerus. The system includes various sizes and types of modular humeral stems, humeral heads, glenoids, replicator plates, and screws for use in primary, revision, and fracture applications.

AI/ML Overview

This 510(k) premarket notification for the Exactech Equinoxe® Shoulder System (K042021) does not contain a study that proves the device meets specific quantitative acceptance criteria in the format requested. Instead, it relies on demonstrating substantial equivalence to predicate devices and provides mechanical testing and engineering analyses to confirm safety and effectiveness.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes the performance testing as: "A number of mechanical tests and engineering analyses were conducted to demonstrate the safety and efficacy of the devices... Test reports detail: 1) the design rationale... 2) the methodology used to demonstrate how these devices were determined to be safe and effective; 3) the results from these mechanical tests and engineering analyses, and 4) the interpretations of the data."

However, specific quantitative acceptance criteria with corresponding device performance values (e.g., minimum fatigue strength, maximum wear rate, etc.) and direct "pass/fail" reporting against those criteria are not detailed in this summary. The general statement is that "these reports demonstrate the effectiveness of the design" and that the components "perform as intended."

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

Sample Size: The document mentions "a number of mechanical tests and engineering analyses." It does not specify the sample sizes for these tests (e.g., how many implants were tested for fatigue, wear, etc.).
Data Provenance: The document implies that the testing was conducted internally by Exactech, Inc. (or contracted by them) as part of the submission process. There is no mention of external data, clinical study data, or data from specific countries of origin beyond the company's US location. The data would be considered prospective in the sense that the tests were designed and executed to support this submission.

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

This information is not applicable to the type of data presented. Mechanical tests and engineering analyses do not typically rely on "ground truth" established by human experts in the same way clinical diagnostic studies do. The "truth" in these tests is objective, measurable physical properties and performance under defined mechanical loads.

4. Adjudication Method for the Test Set:

This is not applicable for mechanical testing. Adjudication methods like 2+1 or 3+1 are used for expert review of human-interpreted data (e.g., radiological images).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done or reported. This document is a 510(k) summary for a medical device (shoulder system) that focuses on mechanical performance and substantial equivalence, not on the interpretative performance of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone performance study was not done or reported. This device is a physical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the mechanical tests, the "ground truth" would be the objective measurements obtained from the tests themselves (e.g., load-to-failure, displacement, wear volume) compared against internal design specifications, industry standards, or the performance of predicate devices. There is no "expert consensus," "pathology," or "outcomes data" ground truth referenced for the mechanical/engineering testing in this summary.

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical implant, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

This is not applicable for the reasons stated above.

Summary

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Exactech Equinoxe® Shoulder System

.63

320 NW 4571 COLE

352 377 1140
FAX 352 378 2617

OCT 2 6 2004

K042021

510(k) Summary Pursuant to 21 CFR 807.92

1. Submitted By: Exactech, Inc. 2320 N.W. 66th Court Gainesville, FL 32653 2. Dr. Gary Miller Contact: Executive Vice President of Research and Development Exactech, Inc. 2320 N.W. 66th Court Gainesville, FL 32653 Phone: (352) 377-1140 Fax: (352) 378-2617 Exactech Equinoxe® Shoulder System 3. Product: 21 CFR Section 888.3660
  Product Code 87 KWS Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Cemented

21 CFR Section 888.3690 Product Code 87 HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic, Cemented or Uncemented

Class II

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510(k) Premarket Notimati Exactech Equinoxe® Shoulder System

243

822 11.11 FAX 352 378 2617

Description:

Intended Use:

The cemented primary humeral stem, long/revision stem, fracture stem, and both the pegged and keeled glenoids are intended for cemented fixation only. The press-fit stems are intended for press-fit applications but may be used with bone cement if deemed appropriate by the surgeon. The long/revision stem is advised when the distal bone quality is insufficient to adequately anchor the primary stems (typically as a result of mid-humeral fractures). The fracture stem is advised for 3 & 4 part fractures of the proximal humerus. All components are supplied sterile.

Technological Characteristics and Substantial Equivalence:

The devices that compose the Equinoxe® Shoulder System are manufactured from similar materials and have similar design features as competitive devices that have been demonstrated to be safe and effective for equivalent indications.

Specifically, the Equinoxe® press-fit humeral stems are substantially equivalent to the Tornier Aequalis (K980244), the Zimmer (Sulzer) Anatomica (K003801), the Plus Orthopedic PROMOS (K032126), and the Arthrex (K010124) press-fit humeral stems. The Equinoxe cemented humeral (short & long) stems are substantially equivalent to the Plus Orthopedic PROMOS (K032126), the Depuy Global (K992065), and the Arthrex (K010124) press-fit humeral stems. The Equinoxe fracture humeral stems are substantially equivalent to the Tornier Fracture (K994392, K003728, K032679), and the Depuy Global FX (K011099 & K984541) fracture humeral stems. The modular eccentric humeral heads are substantially equivalent to the Depuy Global (K974044 & K992065), the Stryker Howmedica Osteonics Solar (K001419), the Tornier Aequalis (K012212), and the Zimmer (Sulzer) Anatomica (K990137) eccentric humeral heads. Finally, the Equinoxe cemented pegged and keeled glenoids are substantially equivalent to the Tornier Aequalis (K994393), the Encore Foundation (K960906), the Plus Orthopedic PROMOS (K032126), the Zimmer (Sulzer) Anatomica (K990136), and the Depuy Global (K981487) cemented glenoids.

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510(k) Premarket Notificati

Exactech Equinoxe® Shoulder System

35/15

352-377-1433
FAX 352-378-2631

Performance Testing:

A number of mechanical tests and engineering analyses were conducted to demonstrate the safety and efficacy of the devices that compose the Equinoxe shoulder system. Test reports detail: 1) the design rationale for each of the devices that compose the Equinoxe shoulder system; 2) the methodology used to demonstrate how these devices were determined to be safe and effective; 3) the results from these mechanical tests and engineering analyses, and 4) the interpretations of the data. Collectively, the reports demonstrate the devices that compose the Equinoxe shoulder system perform as intended and are substantially equivalent to the predicate devices referenced in this submission.

Conclusions:

The Exactech Equinoxe® Shoulder System is substantially equivalent to currently marketed devices with similar indications for use. A comparison of design features, implant scope, critical dimensions, and manufacturing materials indicate that the proposed system has similar fundamental scientific technology and the same intended use as the referenced predicate devices. The safety of the proposed system is further demonstrated by the results of numerous mechanical tests and engineering analyses that have been reported in this submission; collectively, these reports demonstrate the effectiveness of the design. For these reasons, we conclude the Equinoxe Shoulder System is safe and effective when used as intended.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines that suggest the wings and body of the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2004

Dr. Gary Miller Executive Vice President of Research and Development Exactech. Inc. 2320 N.W.66" Court Gainesville, Florida 32653

Re: K042021

Trade/Device Name: Exactech Equinoxe® Shoulder System Regulation Number: 21 CFR 888.3660, 21 CFR 888.3690 Regulation Names: Shoulder joint metal/polymer semi-constrained cemented prosthesis; Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Codes: KWS, HSD Dated: July 27, 2004 Received: July 28, 2004

Dear Dr. Miller:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suated in the encreations of the enactment date of the Medical Device Amendments, or 10 conniner of pror to rial 20, 2017 - 11:57
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. The r ou thay, aterey, inises of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 corply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Dr. Gary Miller

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely, yours,

B. Mark-N. Millerson

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification
-------------------------------	--

Exactech Equinoxe® Shoulder System

/z1

2320 NW GRTH COUL SANT SVILL, FL 326

352 371 1140 FAX 352 378-2617

Indications for Use Statement

510(k) Number:

K64202|

Device Name:

Exactech Equinoxe® Shoulder System

Clinical indications for the PRIMARY (P), LONG/REVISION (L/R) and FRACTURE (F) humeral components are as follows:

P	TR	F	Indications
√	√		rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
√	√		congenital abnormalities in the skeletally mature
√			primary and secondary necrosis of the humeral head.
√		√	humeral head fracture with displacement of the tuberosities
√	√		pathologies where arthodesis or resectional arthroplasty of the humeral head are not acceptable
√	√		revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
		√	displaced three-part and four-part upper humeral fractures
	√		spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
	√		revision of failed previous reconstructions when distal anchorage is required
√	√		to restore mobility from previous procedures (e.g. previous fusion)

X Prescription Use (Per CFR 801.109)

Over-the-counter Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K042021

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.”