# K003016: Pro-Femur R

- Pathway: 510(k) (Abbreviated)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Dec 13, 2000 after 77 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: 9 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
1 of 6 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
- K173898: MicroPort Orthopedics Total Hip Systems MR Labeling (2018), 1 descendant of its own
- K041850: Medallion Modular Hip System (2004), 1 descendant of its own
- K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own
- K240452: Ceramic Femoral Head (2024), 0 descendants of its own
- K130149: U2 Hip System, Expanded Indications for Use (2013), 0 descendants of its own

## Recalls of this device
- Jul 31, 2020 · Class II · Z-2948-2020: MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR¿ Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR¿ Hip Syst
- Jul 31, 2020 · Class I · Z-2941-2020: MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-L
- Jul 31, 2020 · Class I · Z-2942-2020: MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-L
- Jun 30, 2016 · Class II · Z-2588-2016: Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck).
- 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.
- Mar 27, 2007 · Not classified · Z-0868-2007: The titanium plasma coating was found to have missing fragments.
- Mar 27, 2007 · Not classified · Z-0867-2007: The titanium plasma coating was found to have missing fragments.

## Indications for use
Indicated for use in total hip arthroplasty for reduction or relief of pain and for 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 fimctional 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/K003016
Methodology: https://510kreport.com/methodology