OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT

K962082 · Osteonics Corp. · KWS · Aug 13, 1996 · Orthopedic

Device Facts

• Record ID: K962082
• Device Name: OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
• Applicant: Osteonics Corp.
• Product Code: KWS · Orthopedic
• Decision Date: Aug 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteonics® All Polyethylene Shoulder Glenoid Components are single-use devices. They are intended for cemented fixation within the prepared glenoid fossa of the shoulder. The Osteonics® All Polyethylene Glenoid Shoulder Components, in conjunction with their mating humeral components, are intended for total shoulder arthroplasty.

Device Story

The Osteonics All Polyethylene Glenoid Shoulder Component is a prosthetic implant for total shoulder arthroplasty. It is designed for cemented fixation into the surgically prepared glenoid fossa. The device features a spherical bearing surface with a larger radius than the mating humeral head to allow for translation, and a keeled fixation post for stability. It includes an embedded cobalt-chromium x-ray marking wire for radiographic visualization. The device is implanted by an orthopedic surgeon in a clinical/hospital setting. By replacing the damaged glenoid surface, the device aims to reduce pain and restore joint function in patients with severe shoulder pathology.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: ASTM F-648 UHMWPE body; ASTM F-90 cobalt-chromium alloy x-ray marking wire. Design: Keeled fixation post; spherical bearing surface geometry for translation. Fixation: Cemented. Sterilization: Not specified.

Indications for Use

Indicated for patients with aseptic necrosis of the humeral head; painful, disabling shoulder joint disease (degenerative, rheumatoid, or post-traumatic arthritis); proximal humeral fracture/dislocation; revision of previous unsuccessful shoulder procedures; or clinical scenarios where arthrodesis or other reconstructive techniques are less likely to achieve satisfactory results.

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

• Osteonics® All Polyethylene Glenoid Shoulder Components (Osteonics Corp.)
• Global™ Total Shoulder Glenoid Component (DePuy Inc.)

Submission Summary (Full Text)

{0}

K962082
AUG 13 1996

# 510(k) Premarket Notification
## Summary of Safety and Effectiveness
### for the
### Osteonics® All Polyethylene Glenoid Shoulder Component

## Submission Information

| Name and Address of the Sponsor
of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677 |
| --- | --- |
| Contact Person: | Terry Jarosz
Regulatory Affairs Specialist |
| Date of Summary Preparation: | May 28, 1996 |

## Device Identification

| Proprietary Name: | Osteonics® All Polyethylene Glenoid
Shoulder Component |
| --- | --- |
| Common Name: | Total Shoulder Glenoid Component |
| Classification Name and Reference: | Shoulder Joint Metal/Polymer
Semi-Constrained Cemented
Prosthesis
21 CFR §888.3660 |

## Predicate Device Identification

The keeled Osteonics® All Polyethylene Glenoid Shoulder Components are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:

- Osteonics® All Polyethylene Glenoid Shoulder Components: Osteonics Corp.
- Global™ Total Shoulder Glenoid Component: DePuy Inc.

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Osteonics® All Polyethylene Glenoid Shoulder Component
510(k) Premarket Notification

## Device Description

The keeled Osteonics® All Polyethylene Glenoid Shoulder Component is intended for cemented fixation within the surgically prepared glenoid fossa of the shoulder.

The Osteonics® All Polyethylene Glenoid Shoulder Component is shaped to conform to the geometry of the glenoid fossa. Its medial surface is curved so that, when placed against the prepared glenoid cavity, the device conforms to the shape of the cavity. This conformity allows less bone removal and may provide the component with added stability.

The spherical radius of the bearing surface Osteonics® All Polyethylene Glenoid Shoulder Component is larger than the spherical radius of the mating humeral head. This is intended to allow translation.

The Osteonics® All Polyethylene Glenoid Shoulder Component comes in a range of sizes. Each component features a pre-assembled, x-ray marking wire on its medial surface. Each component features a keeled fixation post.

The body of the Osteonics® All Polyethylene Glenoid Shoulder Component is manufactured from ASTM F-648 ultra-high molecular weight polyethylene (UHMWPE). The x-ray marking wire is manufactured from ASTM F-90 cobalt chromium alloy.

## Intended Use:

The Osteonics® All Polyethylene Shoulder Glenoid Components are single-use devices. They are intended for cemented fixation within the prepared glenoid fossa of the shoulder.

The Osteonics® All Polyethylene Glenoid Shoulder Components, in conjunction with their mating humeral components, are intended for total shoulder arthroplasty. The indications for use are as follows:

## Indications:

- Aseptic necrosis of the humeral head.
- Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
- Proximal humeral fracture and/or dislocation.
- Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

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Osteonics® All Polyethylene Glenoid Shoulder Component
510(k) Premarket Notification

## Statement of Technological Comparison:

The technological characteristics of the subject Osteonics® All Polyethylene Glenoid Shoulder Components compare to those of the predicate devices as follows:

## Materials:

The subject Osteonics® All Polyethylene Glenoid Shoulder Components, as well as all of the competitive predicate devices cited above, are made from polyethylene.

## Design:

With regard to design, the subject devices are the same as the predicate Osteonics devices, except that the subject devices feature a keeled fixation post, whereas the predicate components feature fixation pegs. However, keeled post designs are common to several other legally marketed glenoid components, including the competitive predicate device identified above.

## Intended Use:

The subject devices share the same intended uses as the predicate Osteonics device identified above.

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