# K110029: Conserve Bio Foam Shell

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Apr 19, 2011 after 104 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K004043 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021349: Metal Transcend Articulation System (Larger Sizes), Wrightmedicaltechnologyinc (2002) Summary page 1.
- K031963: Conserve Plus Spiked Acetabular Shells and Conserve Total 56MM Femoral Head, Wrightmedicaltechnologyinc (2003) Summary page 1.
- K082924: Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner, Wrightmedicaltechnologyinc (2009) Summary page 1.

## Indications for use
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® BioFoam® shell is intended for cementless hip arthroplasty.

Source page: https://510kreport.com/device/K110029
Methodology: https://510kreport.com/methodology