PRIME MODULAR ENDO HEAD

K962646 · Orthopaedic Innovations, Inc. · KWL · Sep 23, 1996 · Orthopedic

Device Facts

• Record ID: K962646
• Device Name: PRIME MODULAR ENDO HEAD
• Applicant: Orthopaedic Innovations, Inc.
• Product Code: KWL · Orthopedic
• Decision Date: Sep 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Prime Modular Endo Heads, with the Prime Cemented Femoral Stems, are intended to replace the femoral head in cases of femoral head and neck fracture, nonunion of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis, rheumatoid arthritis and revision of failed hip fracture treatment.

Device Story

Modular endoprosthetic device; one-piece spherical head with Morse-type taper; attaches to Prime Cemented Calcar Femoral Stems. Used in orthopedic surgery to replace femoral head. Provides modular component selection for surgeons. Benefits patient by restoring hip joint function in cases of fracture, necrosis, or arthritis.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Cobalt-Chrome Alloy (ASTM F-1537). Design: Spherical head with Morse-type taper. Dimensions: 36mm to 70mm diameter in 1mm increments. Sterilization: Presterile.

Indications for Use

Indicated for patients requiring femoral head replacement due to femoral head/neck fracture, nonunion of fractures, aseptic necrosis, osteoarthritis, rheumatoid arthritis, or revision of failed hip fracture treatment.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• Hemi-Head by Orthomet
• Modular Cathcart Endoprosthesis System by DePuy
• Unipolar Head by Smith and Nephew Richards

Submission Summary (Full Text)

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SEP 23 1996
K 962646

# 510(K) Summary of Safety and Effectiveness

**Submitter:** Orthopaedic Innovations, Inc.
825 South 8th Street, Suite 700
Minneapolis, MN 55404
Telephone: [phone]
Contact: Carolyn M. Steele Husten

**Date of Summary:** 07/01/96

**Product:**
- Classification Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis, 21 CFR 888.3390
- Common Name: Modular Endo Head
- Trade/Proprietary Name: Prime Modular Endo Head

**Substantially Equivalent Products**
Hemi-Head by Orthomet
Modular Cathcart Endoprosthesis System by DePuy
Unipolar Head by Smith and Nephew Richards

**Description**
The Prime Modular Endo Heads feature a one piece spherical endo head and a Morse-type taper. This Morse-type taper provides for modular component selection, allowing the head to attach to the Prime Cemented Calcar Femoral Stems. The Prime Modular Endo Heads are provided in diameters from 36mm to 70mm in 1 mm (one millimeter) increments. It is constructed from Cobalt-Chrome Alloy, per ASTM F-1537. Sold Presterile.

**Intended Use:**
The Prime Modular Endo Heads, with the Prime Cemented Femoral Stems, are intended to replace the femoral head in cases of femoral head and neck fracture, nonunion of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis, rheumatoid arthritis and revision of failed hip fracture treatment.

**Comparison to Substantial Equivalent Products:**
All made of the same types of materials, equivalent in function and design.

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