# K231526: CORAIL Cemented Femoral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Dec 19, 2023 after 207 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K941847 (1994). 188 ancestors in all.
No later device cites it as a predicate yet.
0 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123991: Depuy Corail Amt Hip Prosthesis, Depuy France S.A.S. (2013) Summary page 5.
- K220216: C-Stem AMT LE Prosthesis, Depuy Ireland UC (2022) Summary page 5.

## Indications for use
The use of CORAIL Cemented Femoral Stems is indicated in Total and Hemi hip replacements. 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. Partial hip 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. Avascular necrosis of the femoral head. 3. Non-union of femoral neck fractures. 4. Certain high subcapital and femoral neck fractures in the elderly. 5. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 6. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty. The DePuy CORAIL Cemented Femoral Stems are indicated only for use with bone cement.

Source page: https://510kreport.com/device/K231526
Methodology: https://510kreport.com/methodology