The Equinoxe Shoulder System is indicated for use 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.
The cemented primary humeral stem, long/revision stem, fracture stems and all Equinoxe glenoids are intended for cemented fixation.
The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the discretion the surgeon.
The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
Humeral Heads are intended for use in cemented and press-fit applications.
Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:
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 arthrodesis 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)
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.
The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

Device Description

This submission proposes an increase in the angled surface from 8° to 12°, relative to the 8º posterior augment pegged glenoid devices previously cleared via 510(k) K103419. The proposed Equinoxe UHMWPE 12° Posterior Augment Pegged Glenoids are intended to be used with Equinoxe shoulder system components described in #K042021, #K061454, #K093430, and #K103419.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Exactech® Equinoxe® UHMWPE 12° Posterior Augment Pegged Glenoids™, structured according to your request.

Please note: This device is a physical medical implant, not an AI/Software as a Medical Device (SaMD). Therefore, many of your requested points regarding AI-specific studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance, training set details) are not applicable to this submission. The "study" described is a mechanical test to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical testing per ASTM F2028 - Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation.	Test results and analyses demonstrated substantial equivalence to the predicate device. (Implies performance met or exceeded the predicate and satisfied the standard).

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

Sample Size: Not explicitly stated in the document. Mechanical tests typically involve multiple samples of the actual device component.
Data Provenance: The study was a non-clinical mechanical test, not reliant on patient data.

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

Not Applicable. This is a mechanical test of a physical device, not an evaluation requiring expert interpretation of clinical data or images. The "ground truth" is defined by the objective standards and measurements within the ASTM F2028 test method.

4. Adjudication Method for the Test Set

Not Applicable. As a mechanical test, there is no adjudication of subjective expert opinions. Pass/fail criteria are based on objective measurements against the ASTM standard.

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

No. This is a physical medical device, not an AI/SaMD. MRMC studies are not relevant.

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

No. This is a physical medical device, not an AI/SaMD. Standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

Mechanical Performance Standards: The "ground truth" for this device's performance is adherence to the objective measurements and pass/fail criteria established by the ASTM F2028 standard for glenoid loosening or disassociation.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI/SaMD. There is no "training set."

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

Not Applicable. This is a physical medical device, not an AI/SaMD. There is no "training set" or corresponding ground truth establishment process in this context.

Summary of the Study for this Device:

The study conducted for the Exactech® Equinoxe® UHMWPE 12° Posterior Augment Pegged Glenoids™ was a non-clinical mechanical test performed according to ASTM F2028 - Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation.

The purpose of this study was to demonstrate substantial equivalence to a previously cleared predicate device (Exactech Equinoxe UHMWPE 8 Degree Posterior Augment Pegged Glenoid, K103419). The primary change in the new device was an increase in the angled surface from 8° to 12°.

The acceptance criteria were that the new device's mechanical performance, specifically regarding glenoid loosening or disassociation, would meet the requirements of the ASTM F2028 standard and be comparable to the predicate device. The document explicitly states: "Test result and analyses provided in this 510(k) demonstrate Equinoxe UHMWPE 12° Posterior Augment Pegged Glenoids are substantially equivalent to the cited predicate device." This statement confirms that the device met its acceptance criteria based on the results of the mechanical testing.

Summary

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K111379 (1/3)

Exactech® Equinoxe® UHMWPE 12° Posterior Augment Pegged Glenoids™ Special 510(k) - 510(k) Summary of Safety and Effectiveness

Exactech® Inc. I. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653 Phone: (352) 377-1140 Fax: (352) 378-2617
JUN - 8 2011

FDA Establishment Number 1038671

Contact: Graham Cuthbert Regulatory Affairs Specialist II
May 16, 2011 Date:

II. Proprietary Name:

Exactech Equinoxe UHMWPE 12° Posterior Augment Pegged Glenoids

Common Name:

Glenoid Component

Classification Name:

Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3660, Class II, Product Code: KWS)

Legally Marketed Devices to Which Substantial Equivalence Is Claimed: III.

510(k) Number	Trade or Proprietary or Model Name	Manufacturer
K103419	Exactech Equinoxe UHMWPE 8 Degree PosteriorAugment Pegged Glenoid	Exactech, Inc.

IV. Device Description:

V. Intended Use of the Device

The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemiarthroplasty is determined by the surgeon to be the preferred method of treatment.

The cemented primary humeral stem, long/revision stem, fracture stems and all . Equinoxe glenoids are intended for cemented fixation.

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Exactech® Equinoxe® UHMWPE 12° Posterior Augment Pegged Glenoids™ Special 510(k) - 510(k) Summary of Safety and Effectiveness

The press-fit humeral stems are intended for press-fit applications but may be . used with bone cement at the discretion the surgeon.
The reverse humeral components are intended to be used in cemented applications ● or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
Humeral Heads are intended for use in cemented and press-fit applications. .

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

√	√	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 arthrodesis 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)

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.

The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

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Exactech® Equinoxe® UHMWPE 12° Posterior Augment Pegged Glenoids™ Special 510(k) - 510(k) Summary of Safety and Effectiveness

VI. Rationale for Substantial Equivalence

Intended Use / Indications for Use. The Exactech Equinoxe UHMWPE 12° . Posterior Augment Pegged Glenoids and predicate devices are intended for use in total shoulder joint replacement and have identical indications for use.
Materials. The Exactech Equinoxe UHMWPE 12° Posterior Augment Pegged . Glenoids and predicate devices are composed of identical biocompatible materials conforming to recognized industry standards for permanent implants.
Design Features. The Exactech Equinoxe UHMWPE 12° Posterior Augment . Pegged Glenoids and predicate devices have the same design features, including articulating geometry and fixation.
. Dimensions. The Exactech Equinoxe UHMWPE 12° Posterior Augment Pegged Glenoids and predicate devices have identical geometry for mating with previously cleared humeral stems and humeral heads. The only dimensional difference is an increase in the angled surface from 8° to 12°.
. Packaging and Sterilization. The Exactech Equinoxe UHMWPE 12° Posterior Augment Pegged Glenoids and predicate devices are packaged and sterilized using the same materials and processes.
Device Shelf Life. The Exactech Equinoxe UHMWPE 12° Posterior Augment . Pegged Glenoids and predicate devices have the same shelf life.

Summary of Non-Clinical Performance Data VII.

Mechanical testing per ASTM F2028 - Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation was conducted to demonstrate the safety and effectiveness of the Equinoxe UHMWPE 12° Posterior Augment Pegged Glenoids in support of the claim of substantial equivalence to the predicate device.

Substantial Equivalence Conclusion

Test result and analyses provided in this 510(k) demonstrate Equinoxe UHMWPE 12° Posterior Augment Pegged Glenoids are substantially equivalent to the cited predicate device.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Exactech、Inc. % Mr. Graham Cuthbert Regulatory Affairs Specialist 2320 NW 66" Court Gainesville, Florida 32653

JUN - 8 2011

Re: K111379

Trade/Device Name: Exactech Equinoxe UHMWPE 12° Posterior Augment Pegged Glenoids Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: May 16, 2011 Received: May 17, 2011

Dear Mr. Cuthbert:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 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 803); good manufacturing practice requirements as set

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Page 2 - Mr. Graham Cuthbert

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

F. Rob. Ns. of Robinson
Mark N. Melkerson

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exactech® Equinoxe® UHMWPE 12° Posterior Augment Pegged Glenoids™ Special 510(k) - Indications for Use

KIJ379 510(k) Number:

Device Name: Exactech Equinoxe UHMWPE 12° Posterior Augment Pegged Glenoids

The cemented primary humeral stem, long/revision stem, fracture stems and all Equinoxe · glenoids are intended for cemented fixation.
. The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the discretion the surgeon.
. The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
Humeral Heads are intended for use in cemented and press-fit applications. .

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

√	√		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 arthrodesis or resectional arthroplasty of the humeral head are not acceptable
√	√		Revisions of humeral prostheses when other treatments or devices have failed (where adequatefixation can be achieved)
		√	Displaced three-part and four-part upper humeral fractures
	√		Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerativediseases)
	√		Revision of failed previous reconstructions when distal anchorage is required
√	√		To restore mobility from previous procedures (e.g. previous fusion)

The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient,

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KIII379 (2/2) (IFU)

Exactech® Equinoxe® UHMWPE 12° Posterior Augment Pegged Glenoids™ Special 510(k) - Indications for Use

irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

and/or

Over-The-Counter Use (21 CFR 807 Subpart C)

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

11/11/309 510(k) Number

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.”