ANATOMICA GLENOID COMPONENT

K990136 · Sulzer Orthopedics, Inc. · KWS · Mar 1, 1999 · Orthopedic

Device Facts

• Record ID: K990136
• Device Name: ANATOMICA GLENOID COMPONENT
• Applicant: Sulzer Orthopedics, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Mar 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anatomica Glenoid Component is intended for cemented use in treatment of the following: 1. Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis. 2. Omarthrosis. 3. Rheumatoid arthritis. 4. Revision of shoulder prosthesis. 5. Traumatology: the only cone to be used in traumatological indications is the traumatology cone.

Device Story

Anatomica Glenoid Component is an all-polyethylene shoulder prosthesis; manufactured from ultra-high molecular weight polyethylene. Features bone-saving convex back surface with four threaded anchorage pegs for stability; three peripheral pegs include x-ray markers for radiographic evaluation. Available in three sizes. Intended for cemented implantation in shoulder arthroplasty. Used by orthopedic surgeons in clinical/surgical settings to replace damaged glenoid surfaces. Device provides mechanical articulation surface for shoulder joint; restores joint function; reduces pain associated with arthritis or trauma. Clinical benefit derived from improved joint mobility and stability.

Clinical Evidence

No clinical data provided. Evidence consists of static and dynamic bench testing to verify the device survives physiologic loading.

Technological Characteristics

Material: Ultra-high molecular weight polyethylene. Design: Convex back surface with four threaded anchorage pegs. Features: X-ray markers on three peripheral pegs for radiographic visualization. Sizes: Three available. Fixation: Cemented.

Indications for Use

Indicated for patients requiring shoulder joint replacement due to degenerative, posttraumatic, or rheumatoid arthritis, omarthrosis, or revision of a prior shoulder prosthesis. Traumatology indications require use of the specific traumatology cone.

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

• Sulzer Orthopedics Select Shoulder Curved Back Pegged Glenoid
• Orthomet/3M Modular Neer II Shoulder System
• Zimmer Fenlin Total Shoulder
• Smith & Nephew Richards Cofield Shoulder
• Kirschner/Biomet Atlas Shoulder
• Biomet Bio-Modular Total Shoulder
• Depuy Global Total Shoulder System

Submission Summary (Full Text)

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3/1/99

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Sulzer Orthopedics Anatomica Glenoid Component.

| Manufacturer: | Sulzer Orthopedics Ltd.<br>Grabenstrasse 25<br>CH 6341 Baar, Switzerland |
|-------------------------|-----------------------------------------------------------------------------------------|
| US Designated Agent: | Sulzer Orthopedics Inc.<br>9900 Spectrum Drive<br>Austin, Texas 78717<br>[phone] |
| Date: | January 12, 1998 |
| Contact Person: | Mitchell A. Dhority, RAC<br>Manager, Regulatory Affairs |
| Classification Name: | Shoulder joint metal/polymer semi-constrained cemented prosthesis - 21 CFR 888.3660 |
| Common/Usual Name: | All-Poly Glenoid Component |
| Trade/Proprietary Name: | Sulzer Orthopedics Anatomica Glenoid component |

#### PRODUCT DESCRIPTION

The Anatomica Glenoid component is manufactured from ultra-high molecular weight polyethylene. It features a bone saving convex back surface with four threaded anchorage pegs to ensure stability. The three peripheral anchorage pegs are fitted with x-ray markers to allow for radiographic evaluation. The component is available in three sizes.

### SPECIFIC DIAGNOSTIC INDICATIONS

The Anatomica Glenoid Component is intended for cemented use in treatment of the following:

- 1. Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
- 2. Omarthrosis.
- 3. Rheumatoid arthritis.
- 4. Revision of shoulder prosthesis.
- 5. Traumatology: the only cone to be used in traumatological indications is the traumatology cone.

## SUBSTANTIAL EQUIVALENCE

The Anatomica Glenoid Component is similar to the Sulzer Orthopedics Select Shoulder

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Curved Back Pegged Glenoid, the Orthomet/3M Modular Neer II Shoulder System, the Zimmer Fenlin Total Shoulder, the Smith & Nephew Richards Cofield Shoulder, the Kirschner/Biomet Atlas Shoulder, the Biomet Bio-Modular Total Shoulder, and the Depuy Global Total Shoulder System.

Static and Dynamic Testing indicated that the device would survive physiologic loading.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 1999

Mitchell A. Dhority, RAC Manager, Regulatory Affairs Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

K990136 Re: Anatomica All-Polyethylene Glenoid Component Trade Name: Regulatory Class: III Product Codes: KWS and KWT Dated: January 12, 1999 Received: January 14, 1999

Dear Mr. Dhority:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

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

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Anatomica All-Poly Glenoid Component

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# Indications for Use:

The Anatomica All-Poly Glenoid component is intended use in treatment of the following:

- Advanced wear and tear of the shoulder joint resulting from degenerative, 1. . posttraumatic or rheumatoid arthritis.
- Omarthrosis. 2.
- Rheumatoid arthritis. 3.
- Revision of shoulder prosthesis. 4.
- Traumatology: the only cone to be used in traumatological indications is the 5. traumatology cone.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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(Division Sign-Off Division of General Restorative Devices 510(k) Number

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Over-the Counter Use ____

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