# K051348: Conserve Total Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Aug 19, 2005 after 87 days
- Product code: JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3320
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Metal TRANSCEND® Femoral Heads (Larger Sizes): named in the summary without a submission number

## Recalls of this device
- May 14, 2009 · Not classified · Z-1716-2009: Incorrect packaging, swapped sizes
- May 14, 2009 · Not classified · Z-1715-2009: Incorrect packaging, swapped sizes

## Indications for use
The CONSERVE® Total Femoral Head is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed The CONSERVE® Total Femoral Head is intended for single patient use only.

Source page: https://510kreport.com/device/K051348
Methodology: https://510kreport.com/methodology