# K002320: Accolade C Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Sep 14, 2000 after 45 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: 1 generation back to K911685 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936126: Howmedics DRG Femoral Component, Howmedica, Inc. (1994) Summary page 1.
- K936127: Howmedica Premium Femoral Component, Howmedica, Inc. (1994) Summary page 1.
- K933561: Osteonics Omnifit Forged Hip Stem Series, Osteonics Corp. (1994) Summary page 1.
- K911685: Ranawat/Burstein Porous Total Hip Femoral Comp, Biomet, Inc. (1991) Summary page 1.

## Indications for use
The AccoladeTmC Femoral Component is indicated for cemented primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity. Additionally, this femoral stem can be used in the treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. This stem is also indicated for use in revision procedures where other treatments or devices have failed. The AccoladeTmC Femoral Component is intended for implantation with bone cement.

Source page: https://510kreport.com/device/K002320
Methodology: https://510kreport.com/methodology