# K053588: Profemur  LX Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 13, 2006 after 21 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
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 no predicate by number.

## Indications for use
The PROFEMUR® LX Hip Stem 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 rheumlatoid arthritis; n. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

Source page: https://510kreport.com/device/K053588
Methodology: https://510kreport.com/methodology