Exactech Equinoxe Small Reverse Shoulder System

K180632 · Exactech, Inc. · PHX · Jul 25, 2018 · Orthopedic

Device Facts

• Record ID: K180632
• Device Name: Exactech Equinoxe Small Reverse Shoulder System
• Applicant: Exactech, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Jul 25, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Reverse shoulder arthroplasty system; provides small reverse glenoid plates, small reverse glenospheres, screw components, humeral liners, and surgical instrumentation. Modification of existing Equinoxe Reverse Shoulder System via minor geometry changes. Used in orthopedic surgery for total shoulder replacement. Implants replace damaged joint surfaces to restore function in patients with rotator cuff deficiency. Surgeon-operated in clinical/OR setting. Output is physical joint reconstruction; clinical decision-making based on patient anatomy and pathology.

Clinical Evidence

Bench testing only. Testing included Equinoxe Small Glenoid Plate fixation testing and Glenoid Plate/Glenosphere fixation testing per ASTM F2028, and range of motion evaluation per ASTM F1378. Pyrogen testing performed per USP <161>, USP <85>, and ANSI/AAMI ST72.

Technological Characteristics

Reverse shoulder prosthesis; components include small glenoid plates, glenospheres, screws, and humeral liners. Materials identical to predicate devices. Testing performed per ASTM F2028 (fixation) and ASTM F1378 (range of motion). Sterility per USP <161>, USP <85>, and ANSI/AAMI ST72.

Indications for Use

Indicated for skeletally mature individuals with degenerative glenohumeral joint disease and grossly deficient, irreparable rotator cuff, or failed glenohumeral joint replacement with rotator cuff loss and 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

• Equinoxe Reverse Shoulder System (K063569)
• Equinoxe Reverse Shoulder Line Extensions (K110708)
• Equinoxe Reverse Shoulder System 36mm Glenosphere and Humeral Liners (K093275)
• Equinoxe Total Shoulder – Fixed Angle Replicator Plates, Cast Humeral Heads, and Cast Glenosphere (K102951)
• Equinoxe Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate (K131575)

Submission Summary (Full Text)

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July 25, 2018

Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.

Exactech, Inc. Zach Sharrah Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653

# Re: K180632

Trade/Device Name: Exactech® Equinoxe® Small Reverse 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, KWS, KWS, KWT Dated: June 21, 2018 Received: June 25, 2018

## Dear Zach Sharrah:

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 of medical 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.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Peter G. Allen -S 2018.07.25 11:15:28 -04'00'

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

#### K180632

#### Device Name

Exactech® Equinoxe® Small Reverse Shoulder System

Indications for Use (Describe)

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.

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

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# Exactech® Equinoxe® Small Reverse Shoulder System Special 510(k) - 510(k) Summary of Safety and Effectiveness

| Sponsor: | Exactech®, Inc.<br>2320 NW 66th Court<br>Gainesville FL, 32653 |
|-------------------|---------------------------------------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| | FDA Establishment Number 1038671 |
| Contact Person: | Zach Sharrah<br>Regulatory Affairs Specialist<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | March 5, 2018 |
| Proprietary Name: | Exactech® Equinoxe® Small Reverse Shoulder System |
| Common Name: | Reverse Shoulder Arthroplasty |

## Classification Name:

- . Shoulder Prosthesis, Reverse Configuration (21 CFR Section 888.3660, Class II, Product Code PHX
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer cemented (21 ● CFR Section 888.3660, Class II, Product Code KWS
- Prosthesis, Shoulder, Non-Constrained, Metal/Polymer cemented (21 ● CFR Section 888.3650, Class II, Product Code KWT

| | | Legally Marketed Device to Which Substantial Equivalence Is Claimed: | | |
|--|--|----------------------------------------------------------------------|--|--|
| | | | | |
| | | | | |
| | | | | |
| | | | | |

| Name | Manufacturer | 510(k) Number |
|---------------------------------------------------------------------------------------------------|----------------|---------------|
| Equinoxe Reverse Shoulder System | Exactech, Inc. | K063569 |
| Equinoxe Reverse Shoulder Line Extensions | Exactech, Inc. | K110708 |
| Equinoxe Reverse Shoulder System 36mm Glenosphere and Humeral Liners | Exactech, Inc. | K093275 |
| Equinoxe Total Shoulder – Fixed Angle Replicator Plates, Cast Humeral Heads, and Cast Glenosphere | Exactech, Inc. | K102951 |
| Equinoxe Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate | Exactech, Inc. | K131575 |

## Indications for Use:

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.

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# Exactech® Equinoxe® Small Reverse Shoulder System Special 510(k) - 510(k) Summary of Safety and Effectiveness

#### Device Description:

The Exactech Equinoxe Small Reverse Shoulder System is a reverse shoulder system that provides small reverse glenoid plates, small reverse glenospheres, screw components, humeral liners, and surgical instrumentation for use in reverse total shoulder arthroplasty. The modifications proposed by this submission describe minor geometry changes to the predicate Exactech Equinoxe Reverse Shoulder System; these geometry modifications are the entire basis for the proposed Exactech Equinoxe Small Reverse Shoulder System.

Both the proposed and predicate devices share the following similarities:

- The same Indications for Use ●
- . The same intended use
- The same materials
- . The same design features and basic fundamental scientific technology
- The same compression screws. glenosphere locking screw. humeral liners. . humeral adapter trays, and humeral stem compatibility

#### Non-Clinical Testing:

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

- Equinoxe Small Glenoid Plate Fixation Testing in accordance with ASTM F2028 for Reverse Total Shoulder Arthroplasty
- Equinoxe Small Glenoid Plate/ Glenosphere Fixation Testing in accordance . with ASTM F2028 for Reverse Total Shoulder Arthroplasty
- Range of Motion Evaluation of the Equinoxe Small Reverse Shoulder ● Implants in accordance with ASTM F1378

Pyrogen testing was conducted in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72 to ensure the proposed Equinoxe Small Reverse Shoulder components meet 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:

Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Equinoxe Small Reverse Shoulder System devices are substantially equivalent to the cited cleared predicate Equinoxe devices.