# K113322: Conserve Thin Shell

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Feb 3, 2012 after 85 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042530: Conserve Plus HA Acetabular Shells, Wrightmedicaltechnologyinc (2004) Summary page 1.
- K021349: Metal Transcend Articulation System (Larger Sizes), Wrightmedicaltechnologyinc (2002) Summary page 1.

## Indications for use
The CONSERVE® Thin Shells are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusia 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® Thin Shell is intended for cementless hip arthroplasty.

Source page: https://510kreport.com/device/K113322
Methodology: https://510kreport.com/methodology