AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS

K081707 · Tornier, Inc. · KWS · Jul 17, 2008 · Orthopedic

Device Facts

• Record ID: K081707
• Device Name: AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS
• Applicant: Tornier, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Jul 17, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Aequalis Shoulder System (excluding Acqualis Shoulder Fracture System): Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by: - Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis. - Primary and secondary necrosis of the humeral head - Displaced 4-part upper humeral fracture - Humeral head fracture - Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable - Revision surgery when other treatments or devices have failed. Aequalis Shoulder Fracture System - Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including - humeral head fracture and displaced 3-or 4-part proximal humeral fractures. - Revision surgery when other treatments or devices have failed.

Device Story

Aequalis Shoulder Fracture System and Aequalis Shoulder System are total shoulder prostheses. This modification adds compatibility between existing humeral stems/heads and Affiniti pegged glenoid components (sizes 40-56). The device is a metal/polymer semi-constrained cemented prosthesis used in orthopedic surgery to replace the glenohumeral joint. It functions by providing a mechanical replacement for damaged bone and cartilage, relieving pain and restoring function. The system is implanted by an orthopedic surgeon in a clinical/hospital setting. The output is a physical joint replacement; clinical decision-making is based on patient pathology and fracture severity. Benefits include pain relief and improved joint mobility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Shoulder joint metal/polymer semi-constrained cemented prosthesis. Components include humeral stems, humeral heads, and pegged glenoid components (sizes 40-56).

Indications for Use

Indicated for patients requiring prosthetic shoulder replacement due to severe pain or disability from degenerative pathologies (arthrosis, rheumatoid arthritis, post-traumatic arthrosis), primary/secondary necrosis of the humeral head, humeral head fractures, displaced 3- or 4-part proximal humeral fractures, or revision surgery.

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

• Aequalis Shoulder Fracture System (K994392, K003728, K012212, K032679, K060209)
• Aequalis Shoulder System (K952928, K980244, K012212, K041339, K043077, K060209)
• DVO (now Tornier) Total and Hemi Shoulder System (K060988)

Submission Summary (Full Text)

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081707

p-1/2

# TORNIT

JUL 1 7 2008

# 510(k) Summary

| 510(k) SPONSOR: | Tornier<br>100 Capital Drive, Suite 201,<br>Warsaw, IN 46582 |
|-------------------------------|---------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Jeff Ondrla,<br>Vice President, Product Development<br>[phone]<br>[e-mail] |
| TRADE NAME: | , Aequalis Shoulder Fracture System and Aequalis Shoulder<br>System |
| COMMON NAMES: | Total shoulder prosthesis |
| CLASSIFICATION,<br>and CLASS: | 21 CFR 888.3660 - Shoulder joint metal/polymer semi-<br>constrained cemented prosthesis; Class II |
| PRODUCT CODES: | 87 KWS |

### PREDICATE DEVICES:

Aequalis Shoulder Fracture System: K994392, K003728, K012212, K032679 and K060209

Aequalis Shoulder System: K952928, K980244, K012212, K041339, K043077 and K060209

DVO (now Tornier) Total and Hemi Shoulder System: K060988

#### DEVICE DESCRIPTION:

The labeling for the Aequalis Shoulder Fracture System and Aequalis Shoulder System is being modified to indicate that, when used as total shoulder prostheses, the Aequalis Shoulder Fracture System humeral stems, Aequalis Shoulder System humeral stems and Aequalis humeral heads are compatible with the Affiniti pegged glenoid components in addition to the Aequalis glenoid components that have been previously cleared for use with these systems.

The Affiniti pegged glenoid components are available in sizes 40 - 56.

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# INDICATIONS FOR USE:

Aequalis Shoulder System (excluding Acqualis Shoulder Fracture System):

Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:

81767

- · Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis.
- · Primary and secondary necrosis of the humeral head
- · Displaced 4-part upper humeral fracture
- · Humeral head fracture
- · Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
- · Revision surgery when other treatments or devices have failed.

Aequalis Shoulder Fracture System

- . Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including
- 0 humeral head fracture and displaced 3-or 4-part proximal humeral fractures.
- o Revision surgery when other treatments or devices have failed.

#### BASIS FOR SUBSTANTIAL EQUIVALENCE:

The indications, intended uses, designs, materials and manufacturing methods for the Aequalis Shoulder Fracture System and Aequalis Shoulder System have not changed from those cleared previously in K060209. These systems, with labeling modified to include compatibility with the Affiniti pegged glenoid components, are therefore substantially equivalent to the systems that have been cleared previously.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tornier % Mr. Jeff Ondrla Vice President, Product Development 100 Capital Drive, Suite 201 Warsaw, IN 46582

JUL 1 7 2008

Re: K081707

Trade/Device Name: Aequalis Shoulder Fracture System and Aequalis Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: June 13, 2008 Received: June 17, 2008

Dear Mr. Ondrla:

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.

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. Jeff Ondrla

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Milliman

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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# 081707

#### Indications for Use Statement

510(k) Number (if known): ___

#### Device Name: Aequalis Shoulder Fracture System and Aequalis Shoulder System

Aequalis Shoulder System (excluding Acqualis Shoulder Fracture System):

Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:

- · Degenerative pathologies : arthrosis, rheumatoid arthritis, post-traumatic arthrosis.
- Primary and secondary necrosis of the humeral head a
- Displaced 4-part upper humeral fracture .
- Humeral head fracture .
- · Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
- · Revision surgery when other treatments or devices have failed.

Aequalis Shoulder Fracture System

- Traumatic or pathologic conditions of the shoulder resulting in fracture of the . glenohumeral joint, including
- 0 humeral head fracture and displaced 3-or 4-part proximal humeral fractures.
- Revision surgery when other treatments or devices have failed. ಂ

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Bucheld
Page*1*of*1*

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al. Restorative, and Neurological Devices

510(k) Number K081707