# K052542: Accolade RPS Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Stryker Orthopaedics
- Decided: Sep 27, 2005 after 12 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K941141 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994366: TMZF Press Fit HA Stem and TMZF Press Fit Plus 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/K052542
Methodology: https://510kreport.com/methodology