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 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:

P	L	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 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 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, 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 modifying the Exactech Equinoxe Replicator Plates and Fixed Angled Replicator Plates cleared under 510(k) #K042021 and #K102951. The proposed modifications are as follows:

1. The proposed replicator plates and the fixed angled replicator plates will attach to the humeral head using a morse taper that is half the height of the morse taper of the anatomic replicator plates and fixed angled replicator plates cleared in 510(k) #K042021 and 510(k) #K102951.
  The proposed Exactech Equinoxe Replicator Plates, and Fixed Angled Replicator Plates are intended to be used with the same Equinoxe Shoulder system components described in 510(k). #K042021 and #K102951 as cited predicates.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device: the Exactech® Equinoxe® Shoulder System Short Replicator Plates.

The document discusses the device's equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving the device meets them through clinical studies in the way a new, high-risk device might. This 510(k) is specifically for modifications to an already cleared device, focusing on "short replicator plates." Therefore, the "study" described is a non-clinical performance data assessment to demonstrate substantial equivalence to predicate devices, rather than a clinical trial to establish efficacy or safety for a novel device.

Given this context, I will address your points to the best of my ability based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are not framed as clinical performance metrics (like sensitivity, specificity, etc.) but rather as successful demonstrations of substantial equivalence in non-clinical tests. The "reported device performance" refers to the results of these non-clinical tests.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance
Identical intended use / indications for use	Proposed and predicate devices have identical indications for use.
Identical biocompatible materials conforming to recognized industry standards	Proposed and predicate devices are composed of identical biocompatible materials.
Same key design features; mates with all existing implant and instruments of the Equinoxe shoulder system	Proposed and predicate devices have the same key design features, and mate with all existing implant and instruments of the Equinoxe shoulder system.
Same dimensions and taper geometry; mates with all existing humeral heads (except for shortened taper height)	Proposed and predicate devices have the same dimensions, same taper geometry, and mate with all existing humeral heads; with the exception of the shortened taper height.
Same packaging and sterilization materials and processes	Proposed and predicate devices are packaged and sterilized using the same materials and processes.
Same device shelf life	Proposed and predicate devices have the same shelf life.
Humeral head pull-off strength meets standard (ASTM F2009-00)	Humeral head pull-off to determine taper engagement strength per ASTM F2009-00 was performed, implying it met the standard for substantial equivalence. (Specific numerical result not provided, but conclusion of equivalence implies success).
Humeral head can be impacted on axis (cadaveric validation)	Cadaveric validation confirmed humeral head can be impacted on axis, implying successful demonstration for substantial equivalence. (Specific results not provided, but conclusion of equivalence implies success).

2. Sample Size for the Test Set and Data Provenance

The "test set" in this context refers to the samples used in the non-clinical performance data.

Sample Size: Not explicitly stated. For mechanical tests like "humeral head pull-off," multiple samples would typically be tested, but the exact number is not provided in this summary. For "cadaveric validation," the number of cadavers used is not specified.
Data Provenance: Not explicitly stated, but these are engineering/biocompatibility tests conducted by the manufacturer (Exactech, Inc.) likely in a lab setting. It is not patient data from a specific country, retrospective, or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of submission (510(k) for device modification based on substantial equivalence) does not involve expert review panels to establish "ground truth" in terms of clinical outcomes or diagnoses. The "ground truth" for the non-clinical tests would be the specifications and requirements of the ASTM standard (for mechanical testing) and the functional success of the device in cadaveric validation, evaluated by engineers and biomechanical experts involved in the device's development and testing. No specific number or qualifications of "experts" are noted in this summary with regard to establishing ground truth for testing.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human readers or diagnoses that would require an adjudication method like 2+1 or 3+1. The tests are engineering and biomechanical assessments against established standards.

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

No. An MRMC study is a clinical study designed to evaluate how human readers' performance (e.g., in diagnosis) changes with and without AI assistance across multiple cases. This document describes a 510(k) premarket notification for shoulder system components, focusing on non-clinical data for substantial equivalence, not a clinical study of AI-assisted diagnostic effectiveness.

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

No. This document concerns physical medical devices (shoulder implant components), not algorithms or AI software. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests mentioned is:

Engineering Standards: For the humeral head pull-off test, the "ground truth" is defined by the specific requirements and performance metrics outlined in ASTM F2009-00.
Functional Success: For the cadaveric validation, the "ground truth" is the successful functional demonstration that the humeral head can be impacted on axis, indicating proper mechanical interaction and fit.

8. The Sample Size for the Training Set

Not applicable. This submission does not involve machine learning or AI, so there is no "training set." The focus is on the physical properties and functional aspects of a modified medical implant.

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

Not applicable, as there is no training set for this type of device submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, layered on top of each other. The text is in all caps and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

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

November 2, 2016

Exactech®, Incorporated Mr. Graham L. Cuthbert Regulatory Affairs Specialist II 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K121067

Trade/Device Name: Exactech® Equinoxe® Shoulder System Short Replicator Plates Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWT, KWS, HSD Dated: October 31, 2012 Received: November 6, 2012

Dear Mr. Cuthbert:

This letter corrects our substantially equivalent letter of December 6, 2012.

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, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Graham L. Cuthbert

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exactech® Equinoxe Shoulder System Short Replicator Plates Special 510(k) - Indications for Use

Indications for Use Statement

510(k) Number:

K 121067

Device Name: Exactech® Equinoxe® Shoulder System Short Replicator Plate

INDICATIONS FOR USE

The cemented primary humeral stem, long/revision 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:

P	L	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 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

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	Special 510(k) – Indications for Use
	Spiral and other fractures of the mid-humerus (in combination with glenohumeraldegenerative diseases)

Revision of failed previous reconstructions when distal anchorage is required

Exactech® Equinoxe® Shoulder System Short Replicator Plates

To restore mobility from previous procedures (e.g. previous fusion)

Prescription Use X and/or (Part 21 CFR 801 Subpart D)

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)

Krishna Asundi for (Division Sign-Off) Division of Orthopedic Devices

2012.12.05 17:26:15 -05'00'

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Exactech® Equinoxe® Shoulder System Replicator Plates DEC 0 6 2012 Special 510(k) - 510(k) Summary of Safety and Effectiveness

510(k) Summary of Safety and Effectiveness

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

FDA Establishment Number 1038671

Contact: Graham L. Cuthbert Regulatory Affairs Specialist II

Date: December 3rd, 2012

Trade or Proprietary or Model Name(s):

Exactech® Equinoxe® Shoulder System Replicator Plate, Short, 1.5mm offset Exactech® Equinoxe® Shoulder System Replicator Plate, Short, 4.5mm offset Exactech® Equinoxe® Shoulder System Fixed Angle Replicator Plate, Short, 0mm offset Exactech® Equinoxe® Shoulder System Fixed Angle Replicator Plate, Short, 1.5mm offset Exactech® Equinoxe® Shoulder System Fixed Angle Replicator Plate, Short, 4.5mm offset

Common Name:

Shoulder Prosthesis

Classification Name:

Shoulder joint metal/polymer non-constrained cemented prosthesis (21 CFR 888.3650, Class II, Product Code KWT)

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

Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. (21 CFR Section 888.3690, Product Code HSD)

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Exactech® Equinoxe Shoulder System Replicator Plates Special 510(k) - 510(k) Summary of Safety and Effectiveness

Information on devices to which Substantial equivalence is claimed:

510(k)	Trade or Proprietary or Model Name	Manufacturer
Number K042021	Equinoxe Shoulder System	Exactech, Inc.
K102951	Equinoxe Fixed Angle Replicator Plates	Exactech, Inc.

Device Description:

This submission proposes modifying the Exactech Equinoxe Replicator Plates and Fixed Angled Replicator Plates cleared under 510(k) #K042021 and #K102951. The proposed modifications are as follows:

1. The proposed replicator plates and the fixed angled replicator plates will attach to the humeral head using a morse taper that is half the height of the morse taper of the anatomic replicator plates and fixed angled replicator plates cleared in 510(k) #K042021 and 510(k) #K102951.
  The proposed Exactech Equinoxe Replicator Plates, and Fixed Angled Replicator Plates are intended to be used with the same Equinoxe Shoulder system components described in 510(k). #K042021 and #K102951 as cited predicates.

Intended Use of the Device:

The cemented primary humeral stem, long/revision 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:

P	L	F	Indications
√	√		Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative

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Special 510(k) - 510(k) Summary of Safety and Effectiveness
problems
√ Congenital abnormalities in the skeletally mature

Exactech® Equinoxe® Shoulder System Replicator Plates

√			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 arenot 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 glenohumeraldegenerative 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 manure individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4pait 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.

Rationale for Substantial Equivalence:

Intended Use / Indications for Use - Proposed and predicate devices have identical indications for use.

Materials - Proposed and predicate devices are composed of identical biocompatible materials conforming to recognized industry standards for permanent implants.

Design Features - Proposed and predicate devices have the same key design features, and mate with all existing implant and instruments of the Equinoxe shoulder system.

Dimensions - The proposed replicator plates and fixed angled replicator plates have the same dimensions, same taper geometry, and mate with all existing humeral heads; with the exception of the shortened taper height.

Packaging and Sterilization - Proposed and predicate devices are packaged and sterilized using the same materials and processes.

Device Shelf Life - Proposed and predicate devices have the same shelf life.

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Exactech® Equinoxe® Shoulder System Replicator Plates Special 510(k) - 510(k) Summary of Safety and Effectiveness

Summary of Non-Clinical Performance Data:

Humeral head pull-off to determine taper engagement strength per ASTM F2009-00 .
Cadaveric validation to confirm humeral head can be impacted on axis. .

Substantial Equivalence Conclusion:

Test and analysis provided in this 510(k) submission demonstrate that the proposed Exactech Equinoxe Shoulder System Replicator Plates and Fixed Angled Replicator Plates are substantially equivalent to the cleared predicate 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.”