ADVANTAGE MAPF HIP FEMORAL COMPONENT

K960643 · Biomet, Inc. · KWY · Dec 16, 1996 · Orthopedic

Device Facts

• Record ID: K960643
• Device Name: ADVANTAGE MAPF HIP FEMORAL COMPONENT
• Applicant: Biomet, Inc.
• Product Code: KWY · Orthopedic
• Decision Date: Dec 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Single use, cemented or press-fit hip replacement component for use in patients requiring joint replacement due to trauma, disease or failed previous hip replacement surgery.

Device Story

Advantage MAPF Hip Femoral Component; cobalt alloy (Co-Cr-Mo) femoral stem; straight design; I-beam distal geometry for strength/flexibility; lateral fin for rotational stability; duckbill collar to prevent subsidence. Used in hip replacement surgery; typically for older, low-demand patients; often paired with bipolar or endoprosthetic heads. Articulates with commercially available acetabular components; no joint linkage. Surgeon implants via rasping and seating; straight lateral edge avoids proximal lateral femoral gaps. Benefits include inventory reduction via non-anatomic/non-curved design; 6 size options for patient matching.

Clinical Evidence

No clinical data provided. Safety and effectiveness are based on design equivalence to existing marketed hip replacement components.

Technological Characteristics

Material: Cobalt-chromium-molybdenum (Co-Cr-Mo) alloy. Design: Straight femoral stem, 160mm length, 32mm neck length, 6 sizes. Features: I-beam distal geometry, lateral fin, duckbill collar. Application: Cemented or press-fit. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring hip joint replacement due to trauma, disease, or failed previous hip replacement surgery. Intended for single use; suitable for cemented or press-fit application.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.

Predicate Devices

• Moore Type Stem (Meditac)
• APF Moore-Type Femoral Stem (3M)
• Advantage MAPF Hip System (Kirschner)
• Ranawat/Burstein Hip System (Biomet, Inc)

Submission Summary (Full Text)

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12/10/96 10:15 219 372 1790 BIOMET PURCHSIN 002

# BIOMET

DEC 16 1996
K960643

Corporate Headquarters
Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587

Shipping Address:
Airport Industrial Park
Warsaw, IN 46580

[phone] Office
[phone] FAX

## Summary of Safety and Effectiveness

**Sponsor:** Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw, IN 46581-0578

**Device:** Advantage® MAPF® Hip Femoral Component

**Classification Name:** Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented or Uncemented (KWY)

**Indications for Use:** Single use, cemented or press-fit hip replacement component for use in patients requiring joint replacement due to trauma, disease or failed previous hip replacement surgery.

**Device Description:** The Advantage MAPF Femoral Component is a cobalt alloy (Co-Cr-Mo) femoral stem which is designed to articulate with any commercially available acetabular component. It has no linkage across the joint.

The MAPF devices are straight, as apposed to anatomic or curved in design. This eliminates the need for left and right configurations thus reducing the cost of inventory to the hospital. The I-beam distal geometry increases the strength and flexibility of the device. The lateral edge of the device is straight which enables the surgeon to rasp and seat the prosthesis, without creating a gap in the proximal lateral aspect of the femur. A lateral fin provides rotational stability. The duckbill type collar prevents subsidence.

Available in 6 sizes (diameters) for easier patient matching, all sizes are 160mm in length with a neck length of 32mm. Because this device is usually used in the older, low demand patient, it would most often be used in conjunction with a bipolar or endoprosthetic head.

**Potential Risks:** The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:

| Reaction to the bone cement | Blood vessel damage | Bone fracture |
| --- | --- | --- |
| Deformity of the joint | Soft tissue imbalance | Infection |
| Cardiovascular disorders | Delayed wound healing | Hematoma |
| Fracture of the cement | Metal sensitivity | Dislocation |
| Implant loosening/migration | Fracture of the components | Excessive wear |
| Breakdown of the porous surface | Tissue growth failure | Nerve damage |

**Substantial Equivalence:** In function and overall design, the Advantage MAPF Femoral Components are equivalent to almost all hip components on the market. These stems include:

- Moore Type Stem (Meditac)
- APF Moore-Type Femoral Stem (3M)
- Advantage MAPF Hip System (Kirschner)
- Ranawat/Burstein Hip System (Biomet, Inc)