# K123991: Depuy Corail Amt Hip Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Depuy France S.A.S.
- Decided: Sep 16, 2013 after 264 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- 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: 13 generations back to K941847 (1994). 173 ancestors in all.
48 later devices descend from it; 11 cite it directly.
0 of 221 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070554: Depuy Corail Amt Dysplasia Hip Prosthesis, DePuy Orthopaedics, Inc. (2007) Summary page 1.
- K042992: Corail Amt Hip Prosthesis, DePuy Orthopaedics, Inc. (2005) Summary page 1.
- K120362: Metafix Femoral Stem for Hemi-Arthroplasty, Corin USA (2012) Summary page 1.
- K113242: Apex Arc Hip Stem, Omni Life Science, Inc. (2012) Summary page 2.
- K111193: Apex Arc Hip Stem, Omni Life Science, Inc. (2011)

## Most influential descendants
- K150862: DePuy Actis Duofox Hip Prosthesis (2015), 38 descendants of its own
- K170339: Summit Hip System (2018), 27 descendants of its own
- K160907: DePuy Actis DuoFix Hip Prosthesis (2016), 26 descendants of its own
- K193398: Summit DuoFix HA Coating (2020), 20 descendants of its own
- K202472: ACTIS Duofix Hip Prosthesis (2020), 15 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 replacement or hip arthroplasty 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, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head. 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty. HA coated stems of the Corail Hip System are indicated for cementless use only.

Source page: https://510kreport.com/device/K123991
Methodology: https://510kreport.com/methodology