# K041114: Profemur Tapered Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: May 28, 2004 after 30 days
- Product code: JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 1 cites it directly.
0 of 15 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 its predicate without a number.
- (no number) PROFEMUR® Z Hip Stem: named in the summary without a submission number
- (no number) PERFECTA® RS Hip Stem: named in the summary without a submission number
- (no number) PERFECTA® Plasma Sprayed Hip Stem: named in the summary without a submission number

## Most influential descendants
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 descendants of its own
- K141327: Minima S System (2014), 5 descendants of its own
- K152903: REVIVAL (TM) Modular Revision Hip Stem (2016), 4 descendants of its own
- K140975: Mastersl Femoral Stem (2014), 4 descendants of its own
- K191374: Revival Modular Hip Stem (2019), 3 descendants of its own

## Indications for use
The PROFEMUR® Tapered 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

Source page: https://510kreport.com/device/K041114
Methodology: https://510kreport.com/methodology