AEQUALIS SHOULDER FRACTURE SYSTEM

K032679 · Tornier · KWS · Dec 15, 2003 · Orthopedic

Device Facts

• Record ID: K032679
• Device Name: AEQUALIS SHOULDER FRACTURE SYSTEM
• Applicant: Tornier
• Product Code: KWS · Orthopedic
• Decision Date: Dec 15, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

The AEQUALIS Shoulder Fracture System is a modular orthopedic prosthesis designed for total or hemi-shoulder replacement to treat glenohumeral joint fractures. The system allows for primary hemiarthroplasty with the option for later conversion to total shoulder replacement. The modification adds a long stem option to the existing range. The device is implanted by a surgeon in a clinical setting to replace damaged bone, aiming to restore joint function and eliminate pain.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium alloy (6Al-4V-Ti) per ISO 5832-3; Cobalt-Chromium alloy per ISO 5832-7 or ISO 5832-12. Design: Modular shoulder prosthesis with grit-blasted proximal stem. Classification: Class II, 21 CFR 888.3660, Product Code KWS.

Indications for Use

Indicated for patients with traumatic or pathologic conditions of the shoulder resulting in glenohumeral joint fractures, specifically humeral head fractures and displaced 3- or 4-part proximal humeral fractures.

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)
• AEQUALIS Shoulder Fracture system (K994392)
• AEQUALIS Shoulder Fracture system (K003728)
• Modular Shoulder System, Wright Medical Technology Inc (K002683)

Submission Summary (Full Text)

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DEC 1 5 2003

# Implants Chirt

# Summary of Safety and Effectiveness information Special 510(k) - AEQUALIS Shoulder Fracture System K032679

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

1) Device name Trade name: Common name: Classification name:

## AEQUALIS Shoulder Fracture System

Total-Shoulder System and Hemi-Shoulder System 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 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

Class II Device class: Classification panel: Orthopedic KWS Product code: § 888.3660 Shouldcr joint metal/polymer semi-constrained cemented prosthesis.

## 5) Equivalent / Predicate device

AEQUALIS Shoulder system, TORNIER SA (K952928) AEQUALIS Shoulder Fracture system, TORNIER SA (K994392, K003728) Modular Shoulder System, Wright Medical Technology Inc (K002683)

Image /page/0/Picture/16 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is bold and black, with a unique design where the horizontal bar at the top is slightly curved and extends beyond the vertical stem. The hexagon is outlined in black and provides a geometric border for the letter.

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

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

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K032679

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# Implants Chirurgicau

## 6) Device description

6) Device descriptiou I lie usual goal of total shoulder repace nem ae or eliminate pain. The Aequalis Shoulder Fracture System is intended to accomplish these goals. With the Aequalis Shoulder Fracture System, the natural glenoid incelled to accomplish theor goals. The a 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 them-shoulder. The modular nature of the system allows for the later conversion of a primary hemiarthrosplasty to a total shoulder replacement.

The present Device Modification submission consists in the addition of a long stem to each diameter of the previous range.

## 7) Materials

7) Materials
The stem is made of Titanium alloy (6Al-4V-Ti) according to ISO 5832-3. It is grit-blasted on its proximal The send is made of Thankin and of Cobalt-Chromium alloy according to ISO 5832-7 or ISO 5832-12.

### 8) Indications

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.

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Image /page/1/Picture/10 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is composed of thick, bold lines and has a slightly geometric design. The hexagon provides a border around the letter, creating a distinct and recognizable emblem.

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

SIFGE SOCIAL : B.P. 11 - 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 & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEC 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mireille Lémery Regulatory Affairs and Quality Engineer Tornier S.A. ZIRST - 161, rue Lavoisier 38330 Montbonnot FRANCE

Re: K032679 Trade/Device Name: AEQUALIS Shoulder Fracture System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: November 14, 2003 Received: November 17, 2003

Dear Ms. Lémery:

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 Lémery

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 yours.

b. Mark McMillan

'elia 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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510(k) Number (if known): K032679

AEQUALIS Shoulder Fracture System Device name:

## Indication for use:

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.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE II' NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <i>for</i> Mark N. Mellars |
|--|--------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of General, Restorative<br>and Neurological Devices |
| | 510(k) Number: K032679 |

| Prescription use | <div style="display:inline-block; vertical-align:middle;">✓</div> | OR | Over-The-Counter Use ______ |
|------------------|-------------------------------------------------------------------|----|-----------------------------|
|------------------|-------------------------------------------------------------------|----|-----------------------------|

(Per 21 CFR 801.109) (Optional format 1-2-96)