# K960643: Advantage Mapf Hip Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 16, 1996 after 306 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Moore Type Stem (Meditec): named in the summary without a submission number
- (no number) APF Moore-Type Femoral Stem (3M): named in the summary without a submission number
- (no number) Advantage MAPF Hip System (Kirschner): named in the summary without a submission number
- (no number) Ranawat/Burstein Hip System (Biomet, Inc): named in the summary without a submission number

## 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.

Source page: https://510kreport.com/device/K960643
Methodology: https://510kreport.com/methodology