# K130167: Profemur XM Distal Centralizer

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Apr 19, 2013 after 86 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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 K052915 (2006). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 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.

## Most influential descendants
- K173898: MicroPort Orthopedics Total Hip Systems MR Labeling (2018), 1 descendant of its own
- K240452: Ceramic Femoral Head (2024), 0 descendants of its own

## 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 acetabuti, and painful hip dlysplasia; 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/K130167
Methodology: https://510kreport.com/methodology