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:
| 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 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 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

The Equinoxe Laser Cage Glenoids are intended to be used with Exactech Equinoxe Humeral Head components in Total Shoulder Arthroplasty. The Laser Cage Glenoids are composed of an Ultra High Molecular Weight Polyethylene (UHMWPE) body molded onto Ti-6Al-4V peripheral pegs and a central cage. The central cage and peripheral pegs of the implant are additively manufactured using direct metal printing (DMP) technology. The Laser Cage Glenoids are available in four sizes and four augment angle options.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Exactech® Equinoxe® Laser Cage Glenoid, which is a medical device for shoulder arthroplasty. The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

Therefore, many of the requested categories (acceptance criteria, device performance, sample size, ground truth, experts, adjudication, MRMC studies, standalone performance, training set) are not applicable in the context of this 510(k) submission, as it is not a clinical study assessing an AI/ML diagnostic device.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with reported device performance in a clinical or diagnostic sense. The "acceptance criteria" in a 510(k) submission for a device like this are related to demonstrating substantial equivalence, primarily through:

Identical Indications for Use
Identical Biocompatible Materials
Same Design Features
Dimensionally Comparable
Provided sterile for single use only
Conformity to the same recognized performance standards

The "reported device performance" in this context refers to the results of non-clinical (bench) testing to confirm the physical and mechanical properties, as well as sterility.

Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing)

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance (as per Non-Clinical Testing)
Indications for Use match predicate devices	Identical to predicate devices
Materials match predicate devices	Identical biocompatible materials to predicate devices
Design Features match predicate devices	Same design features as predicate devices
Dimensions are comparable to predicate devices	Dimensionally comparable to predicate devices
Sterility meets standards	Provided sterile for single use only
Performance Requirements conform to standards	Conforms to the same recognized performance standards as predicate devices. Specific tests conducted: Porous Structure Characterization, Glenoid Fixation, Peg Shear Resistance, Peg Pull-Off, Peg Bending Fatigue. Bacterial endotoxin testing conducted in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) submission for a medical implant, not a study of an AI/ML diagnostic device with a test set of data. The "test set" in this context refers to the physical devices undergoing bench testing. The sample size for these bench tests is not specified in the summary document, and data provenance in terms of country of origin or retrospective/prospective is not relevant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No "ground truth" as typically defined for diagnostic performance studies was established. The assessments in this submission are based on engineering, material science, and regulatory compliance, not expert clinical interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for a test set of data was performed, as this is not a diagnostic performance study.

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

Not applicable. This submission is for a physical medical implant (shoulder prosthesis), not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm or AI-based device.

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

Not applicable in the conventional sense of diagnostic performance studies. The "ground truth" for this device's substantial equivalence claim relies on established engineering principles, material specifications, and validated manufacturing processes, all demonstrating that the new device is as safe and effective as the predicate devices. For non-clinical testing, the "ground truth" is defined by the recognized performance standards and internal engineering specifications, e.g., a peg must withstand a certain pull-off force.

8. The sample size for the training set

Not applicable. This is not an AI/ML device where a "training set" would be used.

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

Not applicable. No training set was used.

Summary

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March 4, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Exactech, Inc. Kenneth Maxwell Sr. Regulatory Affairs Specialist 2320 NW 66th Ct. Gainesville, Florida 32653

Re: K212356

Trade/Device Name: Exactech® Equinoxe® Laser Cage Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: February 1, 2022 Received: February 2, 2022

Dear Kenneth Maxwell:

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 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

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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 (QS) 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 Lixin Liu. Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)	K212356
Device Name	Exactech® Equinoxe® Laser Cage Glenoid

Indications for Use (Describe)

The Equinoxe Shoulder System is indicated for use individuals with degenerative diseases or fractures of the glenolumeral joint where total or hemi-arthroplasty is determined by the preferred method of treatment.

The cemented primary humeral stem, longrevision 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 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 Reverse Shoulder System is 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 in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures (hemi-athroplasty), 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 proximation with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superil head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Exactech® Equinoxe® Laser Cage Glenoid Traditional 510(k) - 510(k) Summarv

Company	Exactech, Inc.2320 NW 66th CourtGainesville, FL 32653
Contact Person	Kenneth C. Maxwell IISenior Regulatory Affairs SpecialistPhone: (352) 377-1140Fax: (352) 378-2617
Date	4 March 2022
Proprietary Name	Exactech® Equinoxe® Laser Cage Glenoid
Common Name	Shoulder prosthesis, glenoid component
Classification Name	Shoulder joint metal/polymer semi-constrained cementedprosthesis (Class II per 21 CFR §888.3660)
Product Code	KWS
Classification Panel	Orthopedic

DEVICE DESCRIPTION

INDICATIONS FOR USE

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:

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

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Exactech® Equinoxe® Laser Cage Glenoid Traditional 510(k) - 510(k) Summarv

√	√	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 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.

TECHNOLOGICAL CHARACTERISTICS

The rationale for substantial equivalence is based on consideration of the following device use and characteristics:

Indications for Use. The proposed Laser Cage Glenoids and the predicate devices have ● identical indications for use.
Materials. The proposed Laser Cage Glenoids and the predicate devices are composed of identical biocompatible materials.
Design Features. The proposed Laser Cage Glenoids and the predicate devices have ● the same design features.
Dimensions. The proposed Laser Cage Glenoids and the predicate devices are ● dimensionally comparable.
. Sterilization. The proposed Laser Cage Glenoids and the predicate devices are provided sterile for single use only.
Performance Requirements. The proposed Laser Cage Glenoids and the predicate ● devices conform to the same recognized performance standards.

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LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED

Primary Predicate:

510k Number	Trade or Proprietary or Model Name	Manufacturer
K113309	Equinoxe® Cage Glenoid	Exactech, Inc.

Additional Predicates:

510k Number	Trade or Proprietary or Model Name	Manufacturer
K121220	Equinoxe 12° Posterior Augment Pegged Glenoid	Exactech, Inc.
K111379	Equinoxe 16° Posterior Augment Pegged Glenoid	Exactech, Inc.

REFERENCE DEVICE

510k Number	Trade or Proprietary or Model Name	Manufacturer
K192097	Equinoxe® Stemless Humeral Components	Exactech, Inc.

NON-CLINICAL TESTING

The Equinoxe Laser Cage Glenoid has been tested in the following test modes:

· Porous Structure Characterization
· Glenoid Fixation
· Peg Shear Resistance
· Peg Pull-Off
· Peg Bending Fatigue

Bacterial endotoxin testing was conducted in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72 to ensure the proposed Laser Cage Glenoid meets 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

Based on consideration of indications for use, technological characteristics, biocompatibility of the proposed devices, and results of non-clinical testing, it was concluded the Equinoxe Laser Cage Glenoid demonstrates substantially equivalence to the 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.”