# K970241: Depuy Proximal Femoral Replacement Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Aug 14, 1997 after 204 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
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) Porocoat Proximal Femoral Third Prosthesis: named in the summary without a submission number
- (no number) Proximal Femur Replacement Stem: named in the summary without a submission number
- (no number) Solution Hip Prosthesis: named in the summary without a submission number
- (no number) 5/8 Porocoat AML Hip Prosthesis: named in the summary without a submission number

## Indications for use
The DePuy Proximal Femoral Replacement Prosthesis is indicated for uncemented or cemented use as the femoral component in total hip arthroplasty for replacing the hip joint in the following indications, as appropriate: 1) a severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis, 2) avascular necrosis of the femoral head, 3) acute traumatic fracture of the femoral head or neck, 4) failed previous surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement, and 5) certain cases of ankylosis.

Source page: https://510kreport.com/device/K970241
Methodology: https://510kreport.com/methodology