EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY

K082702 · Exactech, Inc. · PHX · Oct 10, 2008 · Orthopedic

Device Facts

• Record ID: K082702
• Device Name: EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY
• Applicant: Exactech, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Oct 10, 2008
• Decision: SESE
• Submission Type: Special
• 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 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 Exactech® Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Tray is a modular orthopedic implant component. It functions as a line extension to the existing Equinoxe® Reverse Shoulder System. The device is a humeral adapter tray designed to mate with previously cleared primary press-fit, primary cemented, and cemented revision/long humeral stems. Its primary purpose is to provide an additional 15mm of offset to assist in tensioning the deltoid muscle and improving joint stability during shoulder arthroplasty. The device is intended for use by orthopedic surgeons in a clinical/surgical setting. By adjusting the humeral offset, the surgeon can better restore shoulder biomechanics, potentially reducing pain and improving functional outcomes for patients with severe rotator cuff deficiency.

Clinical Evidence

Bench testing only. Engineering studies were performed to validate the dimensional modification and ensure substantial equivalence to the predicate device.

Technological Characteristics

The device is a metal/polymer semi-constrained cemented shoulder prosthesis. It is a modular humeral adapter tray component designed to increase humeral offset by 15mm. It utilizes the same materials, manufacturing processes, and sterilization methods as the predicate Equinoxe® Reverse Shoulder System.

Indications for Use

Indicated for skeletally mature individuals with degenerative glenohumeral joint disease and irreparable rotator cuff deficiency, 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

• Equinoxe® Reverse Shoulder System (K063569)

Submission Summary (Full Text)

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

November 2, 2016

Exactech, Incorporated Shing Jen Tai, PhD Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653

Re: K082702

Trade/Device Name: Exactech® Equinoxe® Reverse Shoulder System +15 mm Humeral Adapter Tray Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, KWT Dated: September 12, 2008 Received: September 16, 2008

Dear Dr. Tai:

This letter corrects our substantially equivalent letter of October 10, 2008.

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. Ilsting 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

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Page 2 - Shing Jen Tai, PhD

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

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 [phone] or [phone] 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 [phone] or [phone] 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® Reverse Shoulder System +15mm Humeral Adapter Tray Special 510(k) - Indications for Use

#### Indications for Use Statement

510(k) Number:

KO82702

Device Name: Exactech® Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Tray

#### 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 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)

(Division Division of Gene 31, Restorative, and Neurological Devices

-Section
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Koranaa

# Exactech® Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Tra Special 510(k) - 510(k) Summary of Safety and Effectiveness

# OCT 1 0 2008

#### 510(k) Summary of Safety and Effectiveness

Exactech® Inc. Sponsor: 2320 N.W. 66" Court Gainesville, FL 32653

> Phone: [phone] Fax: [phone]

FDA Establishment Number 1038671

Shing Jen Tai, PhD Contact: Regulatory Affairs Specialist

Date: September 12, 2008

#### Trade or Proprietary or Model Name(s):

Exactech® Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Tray

### 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)

# Information on devices to which Substantial equivalence is claimed:

| 510(k)<br>Number | Trade or Proprietary or Model Name | Manufacturer |
|------------------|------------------------------------|----------------|
| K063569 | Equinoxe® Reverse Shoulder System | Exactech, Inc. |

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Exactech® Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Special 510(k) - 510(k) Summary of Safety and Effectiveness

### dications for Use:

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

### evice Description:

he proposed Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Tray is a nodification to the existing Equinoxe® Reverse Shoulder System humeral adapter tray devices eviously cleared in K063569. The +15mm humeral adapter tray mates with previously cleared Equinoxe primary press-fit, primary cemented, and cemented revision/long humeral stems (042021) and the Equinoxe reverse shoulder components (K063569). The rationale for the evice line extension is to offer an additional size of offset to tension the deltoid and provide tability.

e predicate and proposed devices have the same intended use and basic fundamental scientific hnology and share the following similarities:

- he same indications for use
- the same design features
- incorporate the same materials
- the same shelf life
- are packaged and sterilized using the same materials and processes.

only modification to the predicate device consists of a proposed dimensional change to crease the thickness of the humeral adapter tray to provide a +15mm offset.

## ostantial Equivalence Conclusion:

esults of engineering studies referenced in this 510(k) submission demonstrate that the ixactech® Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Tray is substantially quivalent to the cleared predicate devices.