# K060358: Profemur TL Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: May 10, 2006 after 86 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.
69 later devices descend from it; 9 cite it directly.
1 of 70 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K072417: Smith & Nephew Mis Hip Stem (2008), 44 descendants of its own
- K080625: Smith & Nephew Mis Hip Stem with Stiktite (2008), 19 descendants of its own
- K103256: Smith & Nephew SMF Hip Stem (2011), 16 descendants of its own
- K083312: Minihip Stem (2010), 15 descendants of its own
- K081124: MDF Revision Hip System (2008), 14 descendants of its own

## Indications for use
The PROFEMUR® TL 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 rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

Source page: https://510kreport.com/device/K060358
Methodology: https://510kreport.com/methodology