# K111698: Profemur (R) E Cementless Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Aug 19, 2011 after 63 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K004043 (2001). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021346: Stem Hip Replacement System, Model PHA002XX, Wrightmedicaltechnologyinc (2002) Summary page 1.
- K012091: Pro-Femur, Wrightmedicaltechnologyinc (2001) Summary page 1.
- K004043: Metal Transcend Articulation System, Wrightmedicaltechnologyinc (2001) 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

## Recalls of this device
- 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.

## Indications for use
The PROFEMUR® E Cementless 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: I. 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® E Cementless Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.

Source page: https://510kreport.com/device/K111698
Methodology: https://510kreport.com/methodology