# K052915: Profemur XTR Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 27, 2006 after 102 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 4 cite it directly.
0 of 9 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
- K111910: Gladiator Hip Stem (2011), 5 descendants of its own
- K130167: Profemur XM Distal Centralizer (2013), 2 descendants of its own
- K201519: PROFEMUR® GLADIATOR® Cemented Classic Stem (2020), 1 descendant of its own
- K173898: MicroPort Orthopedics Total Hip Systems MR Labeling (2018), 1 descendant of its own
- K240046: Ethylene Oxide Sterilization Supplier Change for MPO Hips (2024), 0 descendants of its own

## Recalls of this device
- Sep 5, 2012 · Class II · Z-0183-2013: There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
- Sep 5, 2012 · Class II · Z-0184-2013: There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
- Sep 5, 2012 · Class II · Z-0185-2013: There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.

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

Source page: https://510kreport.com/device/K052915
Methodology: https://510kreport.com/methodology