# K042992: Corail Amt Hip Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Feb 11, 2005 after 102 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K935452 (1994). 15 ancestors in all.
168 later devices descend from it; 27 cite it directly.
0 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953111: Corail, Landos, Inc. (1996) Summary page 1.
- K001991: Titan Porocoat Hip Prosthesis, DePuy Orthopaedics, Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K123392: Avenir Muller Stem (2013), 41 descendants of its own

## Recalls of this device
- Jun 21, 2018 · Class II · Z-2521-2018: Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedur

## Indications for use
Total hip arthroplasty is intended to provide increased patieat 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 comnponects. Total hip replacement is indicated in the following conditions: 1. A severely painful sndlor disabled joint from ostcoarthritis, traumatic afritis, rheunatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3 Acute traumatic fracture of the f£nnoral head or neck 4. Failed previous hip surgery including joint rxconstmotion, internal fixation, artfindesis, bcmiarthroplasty, surface xeplacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The non-porous Corail AMT Ilip Stem is indicated for cemnentless use only.

Source page: https://510kreport.com/device/K042992
Methodology: https://510kreport.com/methodology