AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM

K060209 · Tornier · KWS · Mar 2, 2006 · Orthopedic

Device Facts

• Record ID: K060209
• Device Name: AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM
• Applicant: Tornier
• Product Code: KWS · Orthopedic
• Decision Date: Mar 2, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

AEQUALIS Shoulder Range (except AEQUALIS for Fracture): 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 for Fracture: 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 modular shoulder prostheses for total shoulder replacement or hemi-arthroplasty. System components include humeral stems and glenoid components. Modifications include two additional large glenoid sizes and a hydroxylapatite-coated fracture stem. Devices are implanted by orthopedic surgeons in clinical settings to restore joint function and reduce pain. Modular design allows conversion from primary hemi-arthroplasty to total shoulder replacement. Clinical benefit includes pain relief and restoration of shoulder joint function for patients with degenerative disease or traumatic fractures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Humeral implant: Titanium alloy (ISO 5832-3) or CrCo alloy (ISO 5832-7, 5832-12, 5832-4). Glenoid component: UHMWPE (ISO 5834-2). Hydroxylapatite coating: ASTM F 1185. Modular semi-constrained cemented prosthesis.

Indications for Use

Indicated for patients with severe pain or disability due to degenerative pathologies (arthrosis, rheumatoid arthritis, post-traumatic arthrosis), humeral head necrosis, or traumatic glenohumeral joint fractures (including displaced 3- or 4-part proximal humeral fractures). Also indicated for 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 system (K952928, K041339, K043077)
• AEQUALIS Shoulder Fracture system (K994392, K003728, K032679, K043077)

Submission Summary (Full Text)

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MAR 2 2006

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# Implants Chirurgicaux

K060209

# Summary of Safety and Effectiveness information Special 510(k) Premarket Notification – Aequalis Shoulder Fracture System Aequalis Shoulder System

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

1) Device name Aequalis Shoulder Fracture System & Aequalis Shoulder System Trade name: Common name: Hemi or Total Shoulder Prosthesis Classification name: & 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis

## 2) Submitter

Tornier S.A. 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 : [e-mail]

### 4) Classification

Device class: Class II Classification panel: Orthopedic Product code: KWS

5) Equivalent / Predicate device For the AEQUALIS Shoulder Fracture System: AEQUALIS Shoulder system, TORNIER SA, K952928, K041339, K043077 AEQUALIS Shoulder Fracture system, TORNIER SA, K994392, K003728, K032679, K043077

For the AEQUALIS Shoulder System: AEQUALIS Shoulder system, TORNIER SA, K952928, K041339, K043077

Image /page/0/Picture/14 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and has a unique design, with the top part of the 'T' appearing to be a separate element resting on the vertical line. The hexagon provides a border around the 'T', giving the logo a defined shape.

TORNIER S.A.S. Tél. : [phone], rue Lavoisier - Montbonnot Fax : [phone] 38334 SAINT-ISMIER CEDEX FRANCE

S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B

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SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE

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060209

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#### 6) Device description

The usual goal of total shoulder replacement and hemi-arthroplasty of the shoulder is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease or injury. Thus the Aequalis Shoulder Fracture System is intended for use as a total shoulder replacement system, or as a hemi-shoulder. The modular nature of the system allows for the later conversion of a primary hemiarthrosplasty to a total shoulder replacement.

The present submission corresponds to the following modifications:

- addition of two large glenoid components to the four existing sizes of glenoid both for the Aegualis shoulder Fracture System and the Aequalis shoulder System,
- addition of a model of Fracture Stem covered with hydroxylapatite to the Aequalis shoulder Fracture -System, the new stem is strictly identical to the previously cleared device except for the coating.

#### 7) Materials

The humeral implant is manufactured from titanium alloy (Ti6Al4V) in accordance with ISO standard 5832-3 or in chromium-cobalt alloy (CrCo) according to ISO standard 5832-7, ISO standard 5832-12 or ISO standard 5832-4. The glenoid component is made of ultra high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2.

The hydroxylapatite coating conforms to the ASTM standard F 1185. The coating is performed by BioCoat, Inc. according to their Master File MAF-339.

### 8) Indications

AEQUALIS Shoulder Range (except AEQUALIS for Fracture)

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

- Degenerative pathologies : arthrosis, theumatoid arthritis, post-traumatic arthrosis. Primary and secondary 1 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 for Fracture:

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.

Image /page/1/Picture/21 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is formed by a vertical line with a horizontal bar at the top, and it appears to be enclosed within a shield-like shape. The logo has a textured or slightly rough appearance, possibly indicating it's a scanned image or a design with a hand-drawn aesthetic. The hexagon provides a clear, geometric border for the central design.

Tél. : [phone] TORNIER S.A.S. Fax : [phone], rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE

S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B

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SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2006

Tornier S.A. C/O Mrs. Mireille Lemery Regulatory Affairs Manager 161, Rue Lavoisier- Montbonnot 38334 Saint Ismier Cedex France

Re: K060209

Trade/Device Name: Aequalis Shoulder Fracture System & 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: January 25, 2006 Received: January 31, 2006

Dear Mrs. 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

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Page 2 -- Mrs. Mireille Lemery

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. 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,

Helena Lumer as

Mark N. Melkerson, MS Acting 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):

K060209

Device Name: Aequalis Shoulder Fracture System Aequalis Shoulder System

#### Indications For Use:

#### AEOUALIS Shoulder Range (except AEQUALIS for Fracture):

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 for Fracture:

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.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulut

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

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