MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM

K043077 · Tornier · KWS · Dec 17, 2004 · Orthopedic

Device Facts

• Record ID: K043077
• Device Name: MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM
• Applicant: Tornier
• Product Code: KWS · Orthopedic
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. i Primary and secondary necrosis of the humeral head - Displaced 4-part upper humera! 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 Fraumatio of painting of joing humeral head fracture and displaced 3-or 4-part proximal humeral fractures. Revision surgery when other treatments or devices have failed.

Device Story

The AEQUALIS Shoulder System and AEQUALIS Shoulder Fracture System are orthopedic prosthetic devices designed for total or hemi-shoulder arthroplasty. These implants replace the humeral head and/or glenoid to restore joint function and relieve pain caused by degenerative disease or trauma. The system consists of modular components implanted by orthopedic surgeons in a clinical/hospital setting. The device functions as a mechanical replacement for the natural joint, providing structural support and articulation. Clinical benefit is achieved through the restoration of shoulder mobility and reduction of pain associated with severe joint pathology or complex fractures. The system is intended for use in patients where conservative treatments or other surgical interventions have failed or are not viable.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Shoulder joint metal/polymer semi-constrained cemented prosthesis. Modular design. Materials include metal and polymer components typical of orthopedic joint replacements. Intended for surgical implantation.

Indications for Use

Indicated for patients requiring prosthetic shoulder replacement due to degenerative pathologies (arthrosis, rheumatoid arthritis, post-traumatic arthrosis), primary/secondary humeral head necrosis, displaced 3- or 4-part proximal humeral fractures, or revision surgery after failed prior treatments.

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)
• AEQUALIS Shoulder Fracture system (K994392, K003728, K032679)
• Modular Shoulder System, Wright Medical Technology Inc (K002683)
• Select Shoulder System, Intermedics Orthopedics (K873679)

Submission Summary (Full Text)

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DEC 17 2004

# Implants Chirurgi

# Summary of Safety and Effectiveness information Premarket notification 510(k) - AEQUALIS Shoulder

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

| 1) Device name | |
|----------------------|----------------------------------------------------------------------|
| Trade name: | AEQUALIS Shoulder Fracture System |
| | AEQUALIS Shoulder System |
| Common name: | Total-Shoulder System and Hemi-Shoulder System |
| Classification name: | Shoulder joint metal/polymer semi-constrained cemented<br>prosthesis |

# 2) Submitter

Tornier S.A. B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier - France

# 3) Company contact

Tornier S.A. Mrs Mireille Lémery Regulatory affairs & Quality Engineer ZIRST - 161, rue Lavoisier 38330 Montbonnot - France Tel: [phone] Fax: [phone] e-mail : [e-mail]

4) Classification Device class: Class II Classification panel: Orthonedic Product code: KWS \$ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

# 5) Equivalent / Predicate device

For the AEQUALIS Shoulder Fracture System: AEQUALIS Shoulder system, TORNIER SA, K952928, K041339 AEQUALIS Shoulder Fracture system, TORNIER SA, K994392, K003728, K032679 Modular Shoulder System, Wright Medical Technology Inc, K002683 Select Shoulder System, Intermedics Orthopedics, K873679

Image /page/0/Picture/12 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and appears to be composed of two overlapping 'T' shapes, creating a unique design. The hexagon provides a clear border around the letter, making it stand out. The logo is simple, clean, and likely represents a company or brand with a name starting with the letter 'T'.

TORNIER S.A 161, rue Lavoisier 38330 MONTBONNOT FRANCE

Tél. : [phone] Fax : [phone]

S.A. au capital de 1 800 000 F SIRET : 070 501 275 000 13 R.C.S. : B 070 501 275 CODE APE : 331 B

Page 1/ page 2

SIEGE SOCIAL : B.P. 11 - rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an emblem featuring a stylized eagle with three lines extending from its head, representing health, services, and people.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

Ms. Lemery Mireille Regulatory Affairs & Quality Engineer Tornier S.A. 161 rue Lavoisier 38330 Montbonnot France

Re: K043077

Trade/Device Name: Aequalis Shoulder Fracture system, Aequalis Shoulder System Regulation Name: 21 CFR 888.3660 Shoulder join metal/polymer semi-constrained cemented prosthesis

Regulatory Class: II Product Code: KWS Dated: November 4, 2004 Received: November 16, 2004

Dear Ms. Lemery:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regions) the Medical Device Amendments, or to conninered prof to may 20, 2017 11:57 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 r ou may, dict berey, marks 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 If your device 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 r hat FDA has made a determination that your device complies with other requirements of the Act that I Driver Interes 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 Orth 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. Kathy A. Racosky

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/dsma/dsmamain.html

Sincerely vours,

Sincerely yours,

Mark N. Millerson

Celia M. Witten, Ph.D., M.D. Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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043.77-

Premarket Notification 510(k) AEOUALIS Shoulder Fracture System AEQUALIS Shoulder System

# Indications statement

# 510(k) Number (if known):

Device Name: Aequalis Shoulder Fracture System Aequalis Shoulder System

# 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. i Primary and secondary necrosis of the humeral head
- Displaced 4-part upper humera! 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 Fraumatio of painting of joing 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) 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)

(Division Sign-Off)

Division of General Restorative,

and Neurological Devices

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| 510(k) Number | K043077 |
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