OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM

K970394 · Osteonics Corp. · MEH · Apr 22, 1997 · Orthopedic

Device Facts

• Record ID: K970394
• Device Name: OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM
• Applicant: Osteonics Corp.
• Product Code: MEH · Orthopedic
• Decision Date: Apr 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteonics® Normalized AD-HA Acetabular Components are single-use devices. The shells are intended for cementless fixation within the prepared acetabulum. The Osteonics® Normalized AD-HA Acetabular Components are compatible with any appropriately selected Osteonics hip stem/femoral head combination.

Device Story

Acetabular component system for hip arthroplasty; consists of metal shell and polyethylene insert. Shell intended for cementless fixation in prepared acetabulum. Features include peripheral screw holes, dome hole for plugs, and AD-HA coating. Inserts feature scalloped rim to provide clearance for bone screws. Used by orthopedic surgeons in clinical settings. Provides stable prosthetic socket for femoral head; restores hip function; alleviates pain from degenerative or traumatic joint disease.

Clinical Evidence

Bench testing only. Testing conducted to qualify and characterize AD-HA coating per FDA guidance documents: 'Calcium Phosphate (Ca-P) Coating Draft Guidance' (1992) and 'Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement' (1994).

Technological Characteristics

Shell substrate: ASTM F-67 CP Titanium. Coating: AD-HA (arc-deposited CP Ti, plasma-sprayed hydroxylapatite). Insert: Ultra-high molecular weight polyethylene with cobalt chromium alloy locking wire. Design: Hemispherical, tangent radii shell; scalloped rim insert. Fixation: Cementless. Sterilization: Standard methods.

Indications for Use

Indicated for painful, disabling hip joint disease (degenerative, rheumatoid, or post-traumatic arthritis; late-stage avascular necrosis); revision of unsuccessful femoral head replacement, cup arthroplasty, or other procedures; clinical management where arthrodesis or alternative techniques are less likely to succeed; and cases with poor or inadequate bone stock/acetabular deficiencies.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Osteonics® Secur-Fit™-HA PSL® X’tra Acetabular Component System

Submission Summary (Full Text)

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APR 22 1997
K97 0394
Osteonics® Normalized AD-HA Acetabular Component System
510(k) Summary

# 510(k) Premarket Notification
## Summary of Safety and Effectiveness
## for the
## Osteonics® Normalized AD-HA Acetabular Component System

## 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 Sheridan
Regulatory Affairs Specialist |
| Date of Summary Preparation: | January 31, 1997 |

## Device Identification

| Proprietary Name: | Osteonics® Normalized AD-HA
Acetabular Component System |
| --- | --- |
| Common Name: | Artificial Acetabular Component |
| Classification Name and Reference: | Hip Joint Metal/Ceramic/Polymer
Semi-Constrained Cemented or
Non-Porous Uncemented Prosthesis
21 CFR §888.3353 |

## Predicate Device Identification

The Osteonics® Normalized AD-HA Acetabular Components are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA:

- Osteonics® Secur-Fit™-HA PSL® X’tra Acetabular Component System: Osteonics Corporation.

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Osteonics® Normalized AD-HA Acetabular Component System
510(k) Summary

## Device Description

The Osteonics® Normalized AD-HA Acetabular Components are single-use devices. Each Osteonics® Normalized AD-HA Acetabular Component consists of two pieces: an Osteonics® Normalized AD-HA Acetabular Shell and an Osteonics® Omnifit® Scalloped Cup Insert. The metal shell is intended for cementless fixation within the prepared acetabulum.

The Osteonics® Normalized AD-HA Acetabular Shells are characterized by the following features:

- A basic spherical and tangent radii design.
- The predicate interior geometry which allows a mating polyethylene insert size to be used with more than one shell size.
- Peripheral screw holes.
- A dome hole which is compatible with the optional, currently marketed Osteonics® Acetabular Dome Hole Plugs.
- Circumferential normalizations.
- A wide range of sizes.
- One of two screw hole configurations:
- 6 peripheral screw holes and no dome screw holes,
- 6 peripheral screw holes, and 5-7 dome screw holes.
- Osteonics’ AD-HA coating.

The Osteonics® Omnifit® Scalloped Cup Inserts differ from the predicate Osteonics® Omnifit® Cup Inserts in that they feature a scalloped rim. The scalloped rim allows for clearance between bone screws (which may be placed in the peripheral screw holes of the shell) and the insert’s rim.

## Intended Use:

The Osteonics® Normalized AD-HA Acetabular Components are single-use devices. The shells are intended for cementless fixation within the prepared acetabulum. The Osteonics® Normalized AD-HA Acetabular Components are compatible with any appropriately selected Osteonics hip stem/femoral head combination.

## Indications:

The indications for the use of the Osteonics® Normalized AD-HA Acetabular Components, in keeping with those of other legally marketed Osteonics acetabular components, are as follows:

- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

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Osteonics® Normalized AD-HA Acetabular Component System
510(k) Summary

## Statement of Technological Comparison:

The substantial equivalence of the Osteonics® Normalized AD-HA Acetabular Components to the predicate devices identified above—in terms of intended use, materials, and design features—is based on the following.

## Intended Uses:

The Osteonics® Normalized AD-HA Acetabular Components, like the predicate acetabular components cited above, are intended for cementless fixation. The subject devices and the predicate devices share the same indications for use.

## Materials:

The Osteonics® Normalized AD-HA Acetabular Shells and the predicate acetabular shells cited above are manufactured from the same materials. Both devices have a shell substrate machined from ASTM F-67 CP Titanium. Both devices feature Osteonics’ AD-HA coating (arc-deposited CP Ti, beneath plasma-sprayed hydroxylapatite).

The Osteonics® Omnifit® Scalloped Cup Inserts and the predicate Osteonics® Omnifit® Cup Inserts are both manufactured from ultra-high molecular weight polyethylene, and feature a locking wire made from cobalt chromium alloy.

## Design:

The Osteonics® Normalized AD-HA Acetabular Shells differ from the predicate Osteonics Secur-Fit™-HA PSL® X’tra Acetabular Components as follows:

- The subject acetabular shells feature 6 peripheral screw holes; whereas the predicate devices feature from 6 - 8 peripheral screw holes.
- The peripheral screw holes of the subject shell are completely enclosed within the shell rim; whereas the peripheral screw holes of the predicate shell “break out” from the shell rim.
- The outer geometry of the subject devices features a hemispherical, tangent radii design, whereas the outer geometry of the predicate devices features Osteonics’ Dual Radius geometry.

The Osteonics® Omnifit® Scalloped Cup Inserts differ from the predicate Osteonics® Omnifit® Cup Inserts in that they feature a scalloped rim.

None of these design differences raises any new questions of safety or effectiveness.

## Summary

Based on the similarities presented above, the supporting testing reproduced in Appendix C, the pre-clinical data incorporated by reference to prior submissions, and the fact that the Osteonics®

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Osteonics® Normalized AD-HA Acetabular Component System
510(k) Summary

Normalized AD-HA Acetabular Components employ standard sterilization and packaging methods, the substantial equivalence of the Osteonics® Normalized AD-HA Acetabular Components to other legally marketed, class II, acetabular components is demonstrated.

## Performance Data:

A complete battery of tests, in accordance with the following FDA guidelines, was conducted to qualify and characterize the AD-HA coating of the subject devices: FDA’s “Calcium Phosphate (Ca-P) Coating Draft Guidance for Preparation of FDA Submissions for Orthopedic and Dental Endosseous Implants, November 11, 1992” and FDA’s “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, April 28, 1994.”

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