METAGEN ALL POLY ACETABULAR CUP SYSTEM

K964003 · Metagen, LLC · JDI · Mar 21, 1997 · Orthopedic

Device Facts

• Record ID: K964003
• Device Name: METAGEN ALL POLY ACETABULAR CUP SYSTEM
• Applicant: Metagen, LLC
• Product Code: JDI · Orthopedic
• Decision Date: Mar 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Metagen All Poly Acetabular Cup consists of single use devices, intended for cemented replacement of the acetabular portion of the hip joint in primary and revision total hip arthroplasty.

Device Story

Acetabular component for total hip arthroplasty; single-use; cemented fixation. Device replaces acetabular portion of hip joint. Used by orthopedic surgeons in clinical/OR settings. Provides stable bearing surface for femoral head. Benefits include restoration of hip joint function and mobility.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to legally marketed predicate devices.

Technological Characteristics

Acetabular component for total hip arthroplasty; medical grade biocompatible materials; cemented fixation; single-use.

Indications for Use

Indicated for patients requiring primary or revision total hip arthroplasty for cemented replacement of the acetabular portion of the hip joint.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Orthomet All-Poly Acetabular Cup (Orthomet)
• Charnley/Elite Plus All Poly Cups (DePuy)
• StelKast All Poly Cup (StelKast)

Submission Summary (Full Text)

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MAR 21 1997
K964003

# Summary of Safety and Effectiveness for

## Metagen All Poly Acetabular Cup System

This safety and effectiveness summary for the Metagen All Poly Acetabular Cup System is provided as required per Section 513(I)(3) of the Food, Drug and Cosmetic Act.

1. **Submitter:**
Metagen, LLC
Origen Center
428 Technology Drive East
Menomonie, WI 54751

**Contact Person:**
Wesley Johnson
Telephone: [phone]
Fax: [phone]

**Date Prepared:** October 3, 1996

2. **Tradename:** Metagen All Poly Acetabular Cup System
**Common Name:** Total Hip Prosthesis, Acetabular Component
**Classification Name:** Acetabular Component of Hip Joint, Hip Joint Metal/Polymer, Semi-Constrained Cemented Prosthesis (888.3350)

3. Predicate or legally marketed devices which are substantially equivalent:
- Orthomet All-Poly Acetabular Cup (Orthomet)
- Charnley/Elite Plus All Poly Cups (DePuy)
- StelKast All Poly Cup (StelKast)

4. Description of the device:
The Metagen All Poly Acetabular Cup System is a family of acetabular components designed for use in total hip arthroplasty, that are manufactured using medical grade biocompatible materials. The basic design and materials are the same as those used in the predicate devices.

5. Intended Use:
The Metagen All Poly Acetabular Cup consists of single use devices, intended for cemented replacement of the acetabular portion of the hip joint in primary and revision total hip arthroplasty.

6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:
There are no significant differences between the Metagen All Poly Acetabular Cup and the systems currently being marketed, which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, material and intended use.