Equinoxe® Shoulder System

K243448 · Exactech, Inc. · PHX · Aug 1, 2025 · Orthopedic

Device Facts

• Record ID: K243448
• Device Name: Equinoxe® Shoulder System
• Applicant: Exactech, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Aug 1, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 of 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: [Table of indications omitted for brevity as per instructions to concatenate] 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 Story

Equinoxe Shoulder System is a modular shoulder prosthesis for total or hemi-arthroplasty; includes humeral stems, glenoids, and humeral liners. Subject device introduces Activit-E (highly crosslinked UHMWPE with vitamin E) humeral liners. Device implanted by orthopedic surgeons in clinical settings to restore joint function, mobility, and reduce pain in patients with degenerative joint disease or fractures. Prosthesis replaces damaged glenohumeral joint surfaces; provides structural support and articulation. Surgeon selects components based on patient anatomy and pathology; fixation via cement or press-fit. Benefits include improved joint stability, pain relief, and restored range of motion.

Clinical Evidence

Bench testing only. Testing included humeral liner-tray fatigue and disassembly testing, humeral liner wear testing, particle analysis per ASTM F1877-05:2010, biocompatibility per ISO 10993-1:2018, and bacterial endotoxin testing per USP <161>, USP <85>, and ANSI/AAMI ST72.

Technological Characteristics

Modular shoulder prosthesis components. Subject humeral liners constructed of Activit-E (highly crosslinked UHMWPE with vitamin E). Design features and geometry identical to predicate. Provided sterile for single use. Conforms to recognized performance standards for shoulder replacement devices.

Indications for Use

Indicated for skeletally mature patients with glenohumeral degenerative disease or fractures requiring total or hemi-arthroplasty. Specific indications include rheumatoid arthritis, osteoarthritis, osteonecrosis, post-traumatic degeneration, congenital abnormalities, humeral head fracture with tuberosity displacement, and failed previous reconstructions. Reverse configuration indicated for patients with grossly deficient, irreparable rotator cuff or failed prior replacement with superior humeral head migration.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays (K223833)

Reference Devices

• Vantage® Total Ankle System (K232002)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

August 1, 2025

Exactech Inc.
Liz Howell
Principal Regulatory Specialist
2320 NW 66th Court
Gainesville, Florida 32653

Re: K243448
Trade/Device Name: Equinoxe® Shoulder System
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, PAO
Dated: June 17, 2025
Received: June 17, 2025

Dear Liz Howell:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

U.S. Food &amp; Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K243448 - Liz Howell
Page 2

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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K243448 - Liz Howell
Page 3

Sincerely,

**Joseph P. Russell**
-S

Digitally signed by Joseph P. Russell
Date: 2025.08.01 08:54:18 -04'00'

for: Farzana Sharmin, PhD
Assistant Director
DHT6A: Division of Joint Arthroplasty Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
510(k) Number (if known)
K243448
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement on last page.
Device Name
Equinoxe® Shoulder System
Indications for Use (Describe)

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 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.

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

FORM FDA 3881 (6/20)
Page 1 of 2
PSC Publishing Services [phone]

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FORM FDA 3881 (6/20)

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K234448 - Page 1 of 4

# Equinoxe® Shoulder System
## 510(k) Summary

## Applicant:
Exactech®, Inc.
2320 NW 66th Court
Gainesville FL, 32653
Phone: [phone]
Fax: [phone]

## Applicant Contact:
Liz Howell
Senior Manager, Regulatory Affairs
Telephone: [phone]
Fax: [phone]

## Date:
July 31, 2025

## Device Trade Name:
Equinoxe® Shoulder System

## Common Name:
Shoulder Prosthesis, Reverse Configuration

## Classification Name:
Shoulder joint metal/polymer semi-constrained cemented prosthesis
Shoulder joint metal/polymer non-constrained cemented prosthesis

## Regulation Number:
888.3660, 888.3650

## Product Code:
PHX, KWS, KWT, PAO

## Legally Marketed Predicate Devices:
| Predicate Number | Predicate Trade Name | Product Code |
| --- | --- | --- |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | PHX |

## Reference Devices:
| Reference Number | Reference Trade Name | Product Code |
| --- | --- | --- |
| K232002 | Vantage® Total Ankle System | HSN |

## Device Description Summary
The proposed Equinoxe Activit-E Reverse Humeral Liners are humeral liners intended to be used in reverse total shoulder arthroplasty (rTSA) as a part of the Equinoxe® Shoulder System. The proposed devices are constructed of highly crosslinked UHMWPE containing vitamin E referred to as Activit-E. There are no

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K234448 - Page 2 of 4

# Equinoxe® Shoulder System 510(k) Summary

proposed geometric or compatibility changes as compared to the predicate humeral liner devices cleared in K223833.

# Intended Use/Indications for Use

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 of 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

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K234448 - Page 3 of 4

# Equinoxe® Shoulder System
## 510(k) Summary

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 (hemiarthroplasty), 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.

## Indications for Use Comparison

The subject and the predicate devices have the same indications for use.

## Technological Comparison

The proposed and predicate devices have the same intended use and basic fundamental scientific technology. The technological difference between the predicate and proposed devices is the material. The proposed devices are constructed of highly crosslinked UHMWPE containing vitamin E referred to as Activit-E, whereas the predicate devices are constructed of conventional UHMWPE. There are no proposed geometric or compatibility changes as compared to the predicate humeral liner devices. The rationale for substantial equivalence of the proposed to the predicate cleared devices is based on consideration of the following aspects of the devices:

- The proposed and predicate devices are composed of similar biocompatible materials.
- The proposed and predicate devices have the same design features.
- The proposed and predicate devices are provided sterile for single use only.
- The proposed and predicate devices conform to recognized performance standards for shoulder replacement devices.

## Non-Clinical and/or Clinical Tests Summary &amp; Conclusions

The following non-clinical testing and engineering analyses were performed to demonstrate that the Equinoxe® Shoulder System performs as intended and is substantially equivalent to the identified predicate devices:

- Humeral Liner-Tray fatigue testing
- Humeral Liner-Tray disassembly testing
- Humeral Liner Mode I wear testing
- Post-wear testing particle analysis per ASTM F1877-05:2010

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K234448 - Page 4 of 4

# Equinoxe® Shoulder System 510(k) Summary

- Biocompatibility per ISO 10993-1:2018
- Bacterial endotoxins per USP &lt;161&gt;, USP &lt;85&gt; and ANSI/AAMI ST72

The differences in material do not change the intended use, safety, or performance requirements of the proposed devices, nor do they adversely affect their safety or effectiveness. This conclusion is based on consideration of the preclinical testing and analysis including humeral liner-tray fatigue and disassembly testing, humeral liner wear testing and particle analysis, and biocompatibility assessment completed to establish substantial equivalence of the proposed devices to the predicate devices.