# K001991: Titan Porocoat Hip Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Aug 25, 2000 after 57 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: 4 generations back to K935452 (1994). 13 ancestors in all.
188 later devices descend from it; 10 cite it directly.
0 of 202 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974331: Uni-Rom Total Hip System Femoral Stem, Johnson & Johnson Professionals, Inc. (1998) Summary page 1.
- K934457: Stability Hip Stem with Porocoat, Depuy, Inc. (1994) Summary page 1.
- K953694: Depuy Vision Aml Hip Prothesis, Depuy, Inc. (1996) Summary page 1.

## Most influential descendants
- K042992: Corail Amt Hip Prosthesis (2005), 168 descendants of its own
- K082525: Corin Metafix Femoral Stem (2010), 71 descendants of its own
- K120362: Metafix Femoral Stem for Hemi-Arthroplasty (2012), 61 descendants of its own
- K070554: Depuy Corail Amt Dysplasia Hip Prosthesis (2007), 49 descendants of its own
- K123991: Depuy Corail Amt Hip Prosthesis (2013), 48 descendants of its own

## Indications for use
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The Titan Porocoat Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.

Source page: https://510kreport.com/device/K001991
Methodology: https://510kreport.com/methodology