AEQUALIS RESURFACING HEAD

K062661 · Tornier · HSD · Dec 22, 2006 · Orthopedic

Device Facts

• Record ID: K062661
• Device Name: AEQUALIS RESURFACING HEAD
• Applicant: Tornier
• Product Code: HSD · Orthopedic
• Decision Date: Dec 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aequalis Resurfacing Head is indicated as a total or hemi shoulder joint replacement where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. The replacement of the joint with this device is indicated to relieve severe pain or significant disability caused by: -Degenerative pathologies: osteoarthritis, rheumatoid arthritis, post-traumatic arthritis. Primary and secondary necrosis of the humeral head. -Humeral head fracture. The Aequalis Resurfacing Head is intended for uncemented use only.

Device Story

Humeral head resurfacing prosthesis; designed for conservative joint replacement; preserves bone stock; facilitates potential future revision or arthrodesis. Device implanted by orthopedic surgeons in clinical settings. Provides mechanical replacement for damaged humeral head surfaces; allows for conservation or replacement of natural glenoid elements based on patient pathology. Uncemented fixation; utilizes biological bone-contacting coatings to promote integration. Benefits include reduced bone/cartilage removal compared to total joint implants and simplified surgical technique.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cobalt-Chromium alloy (ISO 5832-4). Bone-contacting surfaces coated with titanium plasma spray (ASTM F1580) and hydroxylapatite (ASTM F1185). Uncemented fixation. Metallic humeral resurfacing prosthesis.

Indications for Use

Indicated for patients requiring total or hemi shoulder joint replacement with sufficient humeral bone stock and intact/reconstructable rotator cuff. Used to relieve pain/disability from osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, primary/secondary necrosis, or humeral head fracture.

Regulatory Classification

Identification

A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.

Predicate Devices

• Aequalis Shoulder System (K952928, K012212, K041339, K043077, K060209)
• Aequalis Shoulder Fracture System (K994392, K032679, K043077, K060209)
• Copeland MB/HA Resurfacing Humeral Head (K010827)
• Global CAP resurfacing Replacement Shoulder (K033516)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "TORNIER" in a bold, serif font. To the right of the word is a hexagonal shape containing a stylized letter "T". The letter "T" inside the hexagon is also in a bold font and has a unique design.

Kob2661

DEC 2 2 2006

## Summary of Safety and Effectiveness information 510(k) Premarket Notification - Aequalis Resurfacing Head

Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92

1) Device name Aequalis Resurfacing Head Trade name: Humeral Resurfacing Common name: 888.3690 Shoulder joint, humeral (hemi-shoulder), metallic uncemented prosthesis Classification name:

2) Submitter Tornier B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier - France

## 3) Company contact Tornier

Mrs Mireille Lémery Regulatory affairs Manager 161. rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex - France Tel: [phone] Fax: [phone] e-mail : mireille [e-mail]

4) Classification Class II Device class: Classification panel: Orthopedic Product code: HSD

5) Equivalent / Predicate device

Aequalis Shoulder System, Tornier, K952928, K012212, K041339, K043077, K060209 Aequalis Shoulder Fracture System, Tornier, K994392, K032679, K043077, K060209 Copeland MB/HA Resurfacing Humeral Head, Biomet, Inc, K010827 Global CAP resurfacing Replacement Shoulder, DePuy Orthopaedics, Inc, K033516

## 6) Device description

The Aequalis Resurfacing Head is a humeral head resurfacing device. It requires less bone and cartilage removal, which makes it much more conservative than total joint implants. Revision or arthrodesis can be undertaken easily because the bone stock has been maintained with no loss of length. The main advantages of humeral head resurfacing are preservation of bone and the relatively simple surgical technique.

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TORNIER SAS 161 rue Lavoisier. Montbonnot. 38334 SAINT-ISMIER Cedex. France Tél. : [phone] Fax : [phone] www.tornier.com SAS au capital de 288 000 €. SIRET 070 501 275 000 13. R.C.S. Grenoble 070 501 275. Code APE 331 B al : chemin Doyen Gosse. 38330 Saint-Ismier. Fra

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Image /page/1/Picture/0 description: The image shows the word "TORNIER" in all capital letters, followed by a logo. The logo is a hexagon with a stylized letter "T" inside. The letter "T" is also enclosed in a smaller hexagon within the larger one.

With the Aequalis Resurfacing Head the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury.

### 7) Materials

The resurfacing head is manufactured from Cobalt-Chromium alloy according to ISO 5832-4. The bone contacting surfaces are coated with titanium plasma spray according to ASTM F1580 and hydroxylapatite according to ASTM F1185.

#### 8) Indications

The Aequalis Resurfacing Head is indicated as a total or hemi shoulder joint replacement where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable.

The replacement of the joint with this device is indicated to relieve severe pain or significant disability caused by:

- Degenerative pathologies: osteoarthritis, theumatoid arthritis, post-traumatic arthritis. Primary and । secondary necrosis of the humeral head.
- Humeral head fracture.

The Aequalis Resurfacing Head is intended for uncemented use only.

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TORNIER SAS

161 rue Lavoisier. Montbonnot. 38334 SAINT-ISMIER Cedex. France Tél. : [phone] Fax : [phone] www.tornier.com au capital de 288 000 €. SIRET 070 501 275 000 13. R.C.S. Grenoble 070 501 275. Code APE 331 B social : chemin Doven Gosse. 38330 Saint-Ismier. Fran

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TORNIER S.A.S % Ms. Mireille Lemery Regulatory Affairs Manager 161 Rue Lavoisier Montbonnot 38334 Saint - Ismier Cedex France

DEC 2 2 2006

Re: K062661

Trade/Device Name: Aequalis Resurfacing Head Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi shoulder), metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: November 30, 2006 Received: December 04, 2006

Dear Ms. Lemery:

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 - Ms. Mireille Lemery

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/industry/support/index.html.

Sincerely yours,

Barbara Buchud

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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# Indications for Use

510(k) Number (if known): K (b 222 (

Device Name: Aequalis Resurfacing Head

Indications For Use:

The Aequalis Resurfacing Head is indicated as a total or hemi shoulder joint replacement where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable.

The replacement of the joint with this device is indicated to relieve severe pain or significant disability caused by:

- -Degenerative pathologies: osteoarthritis, rheumatoid arthritis, post-traumatic arthritis. Primary and secondary necrosis of the humeral head.
Humeral head fracture. 1

The Aequalis Resurfacing Head is intended for uncemented use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

## AND/OR

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

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

llare
CORH, Office of Device Evaluation (ODE)
Division Sign-Off
Moy

Division of General, Restorative, and Neurological Devices

510(k) Number K060261

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Tornier

Section 4