# K022555: Accolade C Femoral Stems

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 26, 2002 after 24 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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 1 cites it directly.
0 of 19 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) Accolade C Femoral Stem: named in the summary without a submission number

## Most influential descendants
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (2019), 7 descendants of its own
- K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (2022), 6 descendants of its own
- K193429: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (2020), 6 descendants of its own

## Recalls of this device
- Aug 31, 2009 · Not classified · Z-0508-2010: Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.
- Aug 31, 2009 · Not classified · Z-0505-2010: Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.
- Aug 31, 2009 · Not classified · Z-0507-2010: Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.
- Aug 31, 2009 · Not classified · Z-0504-2010: Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.
- Aug 31, 2009 · Not classified · Z-0506-2010: Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.
- Nov 13, 2008 · Not classified · Z-0895-2009: Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

## Indications for use
The subject devices are single-use devices intended for use with any currently available Howmedica Osteonics acetabular component, unipolar component, or bipolar component. They may be used with any Howmedica Osteonics cobalt chromium alloy femoral head that can be mated with a 5/40 BG Taper. They may also be used with the Howmedica Osteonics Alumina C-Taper Heads when used with the Adapter Sleeve for V40 to C-Taper Ceramic Heads. The femoral stem is intended for cemented fixation. Indications: Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed; and Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Source page: https://510kreport.com/device/K022555
Methodology: https://510kreport.com/methodology