EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT

K131575 · Exactech, Inc. · PHX · Jul 3, 2013 · Orthopedic

Device Facts

• Record ID: K131575
• Device Name: EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT
• Applicant: Exactech, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Jul 3, 2013
• Decision: SESE
• Submission Type: Special
• 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 hemiarthroplasty 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 wellfixed/stable, as deemed by the orthopaedic surgeon. Humeral Heads are intended for use in cemented and press-fit applications. 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 (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.

Device Story

The Exactech Equinoxe Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate is a surgical implant used in reverse total shoulder arthroplasty. It functions as a glenoid component to replace the shoulder joint surface in patients with degenerative disease and irreparable rotator cuff deficiency. The device is implanted by an orthopedic surgeon in a clinical/hospital setting. It combines a 10-degree superior augment and an 8-degree posterior augment into a single component, with an increased cage peg length (21.5mm) compared to previous versions. The implant provides a stable base for the reverse shoulder construct, restoring joint mobility and function. It is intended for cemented fixation.

Clinical Evidence

Bench testing only. The submission relies on engineering studies and cyclic abduction loosening testing to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Material: Titanium alloy per ASTM F136. Design: Glenoid baseplate with combined 10-degree superior and 8-degree posterior augment; 21.5mm cage peg length. Sterilization: Gamma radiation (SAL 10^-6). Shelf life: 10 years. Connectivity: None (implantable hardware).

Indications for Use

Indicated for skeletally mature patients with degenerative glenohumeral joint disease, fractures, or failed prior arthroplasty. Specific indications include rheumatoid arthritis, osteoarthritis, osteonecrosis, post-traumatic degenerative problems, congenital abnormalities, humeral head fractures with tuberosity displacement, rotator cuff tear arthropathy, and revision of failed prostheses. Contraindications include cases where arthrodesis or resectional arthroplasty are preferred.

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 (K110708)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or eagle in flight, composed of three overlapping profiles.

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

November 2, 2016

Exactech, Incorporated Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 N.W. 66th Court Gainesville , Florida 32653

Re: K131575

Trade/Device Name: Exactech® Equinoxe® 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 Dated: May 29, 2013 Received: May 31, 2013

Dear Mr. Hughes:

This letter corrects our substantially equivalent letter of July 3, 2013.

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 (reporting of medical

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Page 2 - Mr. Patrick Hughes

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/ReportalProblem/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® Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate Special 510(k) - Indications for Use

K131575 510(k) Number: _

Device Name: Exactech® Equinoxe® Reverse Shoulder System

## INDICATIONS

The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemiarthroplasty 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 g 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 wellfixed/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<br>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<br>head are not acceptable |
| √ | √ | | Revisions of humeral prostheses when other treatments or devices have<br>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<br>glenohumeral degenerative diseases) |
| | √ | | Revision of failed previous reconstructions when distal anchorage is<br>required |
| √ | √ | | To restore mobility from previous procedures (e.g. previous fusion) |
| √ | √ | √ | Rotator cuff tear arthropathy |

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# Exactech® Equinoxe® Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate Special 510(k) - 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.

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.

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)

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JUL 0 3 2013

## Exactech® Equinoxe® Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate Special 510(k) - 510(k) Summary

Exactech. Inc. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653 · ·

> Phone: [phone] [phone] Fax:

FDA Establishment Number 1038671

Patrick Hughes Contact: Senior Regulatory Affairs Specialist

May 28, 2013 Date:

# Trade of Proprietary or Model Name(s):

Exactech® Equinoxe Superior/Posterior Augment Reverse Shoulder Glenoid Baseplates

#### Common Name:

Reverse Total Shoulder Arthroplasty - Glenoid Components

### Classification Name:

Prosthesis, shoulder, semi-constrained, metal/polymer cemented (CFR 888.3660, Shoulder joint metal/polymer semi-constrained cemented prosthesis Class II. Product Code KWS)

### Information on devices to which substantial equivalence is claimed:

| 510(k) Number | Trade of Proprietary Model Name | Manufacturer. |
|---------------|---------------------------------|---------------|
| K110708 | Equinoxe Reverse Shoulder | Exactech, Inc |

#### 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 hemiarthroplasty 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 wellfixed/stable, as deemed by the orthopaedic surgeon.
- Humeral Heads are intended for use in cemented and press-fit applications. .

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## Exactech® Equinoxe® Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate Special 510(k) - 510(k) Summary

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) |
| √ | √ | √ | Rotator cuff tear arthropathy |

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 (hemiarthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral ioint (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 proposed Equinoxe Superior/Posterior Augment Reverse Shoulder Glenoid Baseplates are modifications to augmented Equinoxe reverse shoulder glenoid baseplate devices cleared through premarket notification #K110708.

This submission proposes the following design changes:

- 1) The proposed device combines a 10° superior augment and an 8° posterior augment previously provided as separate options in the scope of the cited predicate devices

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## Exactech® Equinoxe® Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate Special 510(k) - 510(k) Summary

- 2) The cage peg length is increased to 21.5mm as compared to 17mm for the predicate 10° superior augment glenoid baseplate and 15.7mm for the predicate 8º posterior augment glenoid
### Comparison of Technological Characteristics

The predicate and proposed devices have the same intended use and basic fundamental scientific technology. The intended use of the modified device, as described in the labeling, has not changed as a result of the proposed modifications. The modified devices share the following similarities with the predicate devices:

- Indications for use .
- . Design features (including mating geometry and locking mechanism)
- Material (titanium alloy per ASTM F136) .
- 10-year shelf life
- Packaging and sterilization materials and processes (gamma radiation . sterilization to a sterility assurance level of 10°).

The proposed components are not being submitted as the result of a recall or any corrective action related to the Equinoxe product lines.

#### Non-Clinical Performance Data

Table 1 shows non-clinical performance data provided, cited, or referenced in this submission to support a conclusion of substantial equivalence:

## Table 1: Equinoxe Superior/Posterior Augmented Glenoid Testing

| | <br>1 2 4 4 1 1 1 1 1 1 1 Evaluation 1 1 2 1 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 1 2 1 2 1 1 2 1 1 1 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fixation assessment | yelic abduction loosening testing |

### Substantial Equivalence Conclusion:

Comparison analysis and results of engineering studies referenced in this 510(k) submission demonstrate proposed Equinoxe Superior/Posterior Augment Reverse Shoulder Glenoid Baseplates are substantially equivalent to predicate augmented Equinoxe baseplates cleared through premarket notification #K110708.

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