# K012091: Pro-Femur

- Pathway: 510(k) (Abbreviated)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 3, 2001 after 90 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
88 later devices descend from it; 9 cite it directly.
0 of 89 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
- K071916: Metha Hip System (2008), 68 descendants of its own
- K083495: Modification to: Metha Hip System (2009), 59 descendants of its own
- K090845: Apex Arc Hip Stem (2010), 58 descendants of its own
- K111193: Apex Arc Hip Stem (2011), 53 descendants of its own
- K113242: Apex Arc Hip Stem (2012), 52 descendants of its own

## Recalls of this device
- Nov 17, 2016 · Class II · Z-0943-2017: The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. The broach handles may have machining issues that do not allow the

## Indications for use
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; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Source page: https://510kreport.com/device/K012091
Methodology: https://510kreport.com/methodology