# K984154: Apf Porous Coated Line Extension

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 11, 1999 after 84 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K941847 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852585: Porous Apf/Modular Femoral Component, Biomet, Inc. (1985) Summary page 2.
- K921225: Integral Total Hip System, Biomet, Inc. (1994) Summary page 2.
- K971824: Reach Femoral Hip Component, Biomet, Inc. (1997) Summary page 2.
- K964650: TCP-Coated Porocoat Aml Femoral Hip Prosthesis, Depuy, Inc. (1997) Summary page 2.
- K941942: Solution Hip, Depuy, Inc. (1994) Summary page 2.

## Indications for use
Biomet’s APF Porous Coated Line Extension Prosthesis is intended for use in reconstruction of the hip joint due to damage caused by trauma or degenerative disease and in cases where a previous hip replacement component has failed. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnosis. The device is a single use implant.

Source page: https://510kreport.com/device/K984154
Methodology: https://510kreport.com/methodology