# K964650: TCP-Coated Porocoat Aml Femoral Hip Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Jun 19, 1997 after 211 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 K941847 (1994). 2 ancestors in all.
311 later devices descend from it; 2 cite it directly.
0 of 313 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 1.
- K941847: 5/8 Porocoat Aml Hip  Porocoat Porous Coating, Depuy, Inc. (1994) Summary page 1.

## Most influential descendants
- K980711: Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating (1998), 309 descendants of its own
- K030733: Mayo Conservative Hip Prosthesis, Model 8026 Series (2003), 296 descendants of its own
- K040191: Bicontact Hip Stem and Femoral Head (2004), 267 descendants of its own
- K001277: Triflange Acetabular Cup System (2000), 213 descendants of its own
- K031495: Pinnacle Duofix HA Acetabular Cup Prosthesis (2003), 207 descendants of its own

## Indications for use
The TCP-coated Porocoat® AML® Femoral Hip Prosthesis, with an appropriate Co-Cr-Mo alloy metal femoral ball, is intended to be used as the femoral component in total hip replacement. This femoral hip prosthesis is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating. This prosthesis may be used where x-ray evidence of sufficient sound bone to seat the femoral component exists. The prosthesis may be used for total hip replacement 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. 5. Certain cases of ankylosis.

Source page: https://510kreport.com/device/K964650
Methodology: https://510kreport.com/methodology