# K051995: Profemur Renaissance Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Aug 22, 2005 after 28 days
- Product code: JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 3 cite it directly.
0 of 13 devices 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.

## Most influential descendants
- K072817: Echelon Titanium Hip System (2008), 6 descendants of its own
- K110101: Taper Oxinium Femoral Head (2011), 5 descendants of its own
- K130984: Profemur Renaissance Classic Hip Stem (2013), 4 descendants of its own
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own
- K141235: Profemur Renaissance Classic Long Neck Hip Stems (2014), 3 descendants of its own

## Indications for use
The PROFEMUR® RENAISSANCETI 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 ostcoarthritis, 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/K051995
Methodology: https://510kreport.com/methodology