# K113019: Profemur XM Wingless Distal Centralizer, Perfecta Distal Centralizer

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Nov 10, 2011 after 30 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: 1 generation back to K911052 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052915: Profemur XTR Hip Stem, Wrightmedicaltechnologyinc (2006) Summary page 1.
- K911052: Nexus (TM) Femoral Hip Stem, Dow Corning Wright (1991) Summary page 1.

## Indications for use
The PMMA Distal Centralizers are intended 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 The PMMA Distal Centralizers are single use components, intended for use as part of a cemented total hip arthroplasty.

Source page: https://510kreport.com/device/K113019
Methodology: https://510kreport.com/methodology