EQUINOXE REVERSE SHOULDER SYSTEM

K063569 · Exactech, Inc. · PHX · Feb 23, 2007 · Orthopedic

Device Facts

• Record ID: K063569
• Device Name: EQUINOXE REVERSE SHOULDER SYSTEM
• Applicant: Exactech, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Feb 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Exactech Equinoxe™ Reverse Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe™ Reverse Shoulder System is also indicated for failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

Device Story

The Equinoxe Reverse Shoulder System is a semi-constrained total shoulder prosthesis designed for joint replacement in patients with irreparable rotator cuff deficiency. The system comprises humeral stems (primary/revision), humeral adapter plates, glenospheres, humeral liners, and screws. It is implanted by orthopedic surgeons in a clinical/hospital setting. The device functions by replacing the glenohumeral joint, shifting the center of rotation to improve stability and range of motion while minimizing inferior impingement and scapular notching. Clinical benefit includes pain relief and restoration of shoulder function. The system is compatible with primary press-fit, primary cemented, and long/revision humeral stems.

Clinical Evidence

No clinical data. Evidence consists of bench testing including dynamic loading studies in polyurethane bone substitutes and cadaveric models, comparative geometric analyses of center of rotation and design parameters, and finite element analysis for fracture resistance.

Technological Characteristics

Semi-constrained reverse shoulder prosthesis. Materials: equivalent to industry standards for permanent implants. Components: humeral stems, adapter plates, glenospheres, humeral liners, screws. Sterilization: equivalent to industry standards. Design features: optimized center of rotation and geometry to maximize range of motion and minimize inferior impingement/scapular notching.

Indications for Use

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

• Depuy Delta III Reverse Shoulder (K021478, K050315, K062116)
• Tornier Reverse Shoulder (K030941, K041873, K050316)
• Zimmer BF Reverse Shoulder (K052906, K060704)
• Zimmer Anatomica Reverse Shoulder (K053274)
• Encore Reverse Shoulder (K041066, K051075, K052086)

Submission Summary (Full Text)

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K063569

# 510(k) Summary

2320 NW 66TH COURT GAINESVILLE, F1 32653

352-377-1140 FAX [phone]

FEB 2 3 2007 Company: Exactech, Inc Date: November 28, 2006 Contact Person: Amnon Talmor, Regulatory Affairs Representative Proprietary Name: Exactech Equinoxe™ Reverse Shoulder System Common Name: Reverse Shoulder Prosthesis Classification Name: Shoulder joint metal/polymer non-constrained cemented prosthesis (21 CFR 888.3650, Class II, Product Code KWT) Prosthesis, Shoulder, Semi-constrained, metal/polymer cemented (21 CFR 888.3660, Class II, Product Code KWS)

# Legally Marketed Devices to Which Substantial Equivalence Is Claimed

- Depuy Delta III Reverse Shoulder (#K021478, #K050315, #K062116) .
- Tornier Reverse Shoulder (#K030941, #K041873, #K050316) .
- Zimmer BF Reverse Shoulder (#K052906, #K060704)
- . Zimmer Anatomica Reverse Shoulder (#K053274)
- . Encore Reverse Shoulder (#K041066, #K051075, #K052086)

## Device Description

The Equinoxe™ Reverse Shoulder System includes a reverse semi-constrained prosthesis for use in total-shoulder joint replacement procedures in cases with an irreparable or nonfunctional totator cuff. The system includes primary and revision humeral stems, various sizes and types of humeral adapter plates, glenospheres, humeral liners, and screws. The reverse shoulder System is designed to function with the Equinoxe primary press-fit, primary cemented, and long/revision humeral stems. All components are supplied sterile.

#### Indications for Use

The Exactech Equinoxe™ Reverse Shoulder System is indicated to relieve pain and restore function in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe™ Reverse Shoulder System is also indicated for failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

# Summary of Technological Characteristics

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

- Intended Use. Equinoxe™ Reverse Shoulder System and predicate devices are intended . for use in total reverse shoulder joint replacement and have similar indications for use statements.
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- Materials. Equinoxe " Reverse Shoulder System and predicate devices are composed of . equivalent materials conforming to recognized industry standards for permanent implants.
- Dimensions. Equinoxe™ Reverse Shoulder System and predicate device components ● are available in equivalent size ranges.
- Sterilization processes. Equinoxe™ Reverse Shoulder System and predicate devices are . sterilized using equivalent sterilization processes conforming to recognized industry standards.
- Performance specifications. Equinoxe™ Reverse Shoulder System and predicate . devices conform to recognized performance standards for total shoulder joint replacement devices.

### Summary of Non-Clinical Performance Data

Mechanical tests, engineering analyses, and simulated surgical (sawbones and cadaver) implantations were conducted to demonstrate the safety and effectiveness of the devices that compose the Equinoxe™ Reverse Shoulder System and support the claim of substantial equivalence to the predicates listed above; a summary of these tests and analyses are as follows:

- A dynamic loading study in which the stability of the Equinoxe Reverse Shoulder was . assessed in a polyurethane bone substitute (TR-2006-052) and in a cadaver (TS-2006-024). The glenoid plate/glenosphere micromotion measurements obtained in this study are compared to that associated with the Depuy Delta III and Encore RSP components when subjected to a similar loading pattern.
- A comparative assessment of the glenosphere center of rotation that demonstrates the . location of the center of rotation is similar for the Equinoxe and Delta III designs. This observation in conjunction with the micromotion test results (TR-2006-052 and TS-2006-024) suggest that the low reported incidence of glenoid loosening associated with the Grammont Reverse Shoulder is applicable to the Equinoxe™ Reverse Shoulder design (TR-2006-053).
- A geomettic analysis of the Grammont Reverse Shoulder Prosthesis-an evaluation of . the relationships between prosthetic design parameters and clinical failure modes (TR-2006-028). This assessment was used to optimize the design parameters associated with the Equinoxe design in order to maximize ROM and minimize inferior impingement.
- A geometric analysis vetification study that demonstrates the Equinoxe Reverse . Shoulder achieves an increase in the amount of motion and a decrease in the amount of inferior impingement (a measure of motion and stability, indicative of scapular notching) while maintaining a similar amount of jump distance (a measure of stability, indicative of the probability of dislocation) relative to the Grammont/Delta III design (TR-2006-029).
- A finite element analysis that demonstrates the geometry of the proposed devices is not � subject to fracture when subjected to a worst-case load (TR-2006-039).

### Substantial Equivalence Conclusion

Results from mechanical tests and engineering analyses provided within this 510(k) demonstrate that the Equinoxe™ Reverse Shoulder System is substantially equivalent to the identified predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Exactech, Inc % Mr. Amnon Talmor Regulatory Affairs Representative 2320 NW 66th Court Gainesville, Florida 32653

FEB 2 3 2007

Re: K063569

Trade/Device Name: Equinoxe Reverse Shoulder System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: KWT Dated: November 27, 2006 Received: November 29, 2006

Dear Mr. Talmor:

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 for are cased in 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Mr. Amnon Talmor

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Corbace Buehup

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K663569

# Exactech®, Inc.

# Indications for Use

510(k) Number (if known):

Device Name: Equinoxe Reverse Shoulder System

## INDICATIONS FOR USE:

The Exactech Equinoxe™ Reverse Shoulder System is indicated to relieve pain and restore function 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 failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

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)

Clarlare Buchnd
(Division Signer)

(Division Sign-Off) Division of General, Restorative, and Neurological General, Resto

**510(k) Number** K063569

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