# K053528: Short Citation Femoral Stem

- Pathway: 510(k) (Special)
- Applicant: Stryker Orthopaedics
- Decided: Jan 13, 2006 after 25 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K941141 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993768: Citation TMZF HA Stem, Howmedica Osteonics Corp. (2000) Summary page 2.

## Indications for use
Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Revision procedures where other treatments or devices have failed.

Source page: https://510kreport.com/device/K053528
Methodology: https://510kreport.com/methodology