# K081090: Profemur LX 5/8 Coated Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: May 15, 2008 after 29 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.
20 later devices descend from it; 3 cite it directly.
1 of 21 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
- K100866: Profemur Hip System Modular Necks (2010), 14 descendants of its own
- K112080: Preserve Hip Stem (2011), 8 descendants of its own
- K111910: Gladiator Hip Stem (2011), 5 descendants of its own
- K150302: PROFEMUR Preserve Classic Stem (2015), 4 descendants of its own
- K112150: Profemur Gladiator HA Hip Stem (2011), 4 descendants of its own

## Indications for use
The PROFEMUR® LX 5/8 Coated 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 The PROFEMUR® LX 5/8 Coated Hip Stem is intended to be used in cementless total hip arthroplasty.

Source page: https://510kreport.com/device/K081090
Methodology: https://510kreport.com/methodology