# K971824: Reach Femoral Hip Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 4, 1997 after 202 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921225 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P820024: Prosthesis, Hip, Hemi-Femoral, Metal, Depuy, Inc.. FDA lists this PMA only through its supplements; the earliest we hold is P820024/S001 (Mar 16, 1984). Summary page 2.
- K933942: Solution Bowed Femoral Hip Protsthesis, Depuy, Inc. (1994) Summary page 2.
- K941942: Solution Hip, Depuy, Inc. (1994) Summary page 2.
- K953703: Depuy Vision Solution Hip Prosthesis, Depuy, Inc. (1996) Summary page 2.
- K921225: Integral Total Hip System, Biomet, Inc. (1994). Our OCR of the scanned summary read K921255, FDA’s number for Philips BV26 Mobile C-Arm Stand (Philips Medical Systems, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “integral® Total Hip System”.

## Most influential descendants
- K984154: Apf Porous Coated Line Extension (1999), 0 descendants of its own

## Indications for use
The Reach Femoral Component is intended for use in reconstruction of the hip joint due to damage caused by trauma or degenerative disease and in cases where previous hip replacement component 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. Use with a Biomet Ceramic Modular Head component or Hetal%ic Modular Head component with appropriate matching Type I Taper.

Source page: https://510kreport.com/device/K971824
Methodology: https://510kreport.com/methodology