# K971409: Osteonics Alumina C-Taper Head

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Jul 9, 1997 after 84 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
No predicates in its family tree.
31 later devices descend from it; 4 cite it directly.
0 of 32 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) Osteonics® Omnifit® Ceramic Morse Taper Head: named in the summary without a submission number
- (no number) Osteonics® Zirconia C-Taper Femoral Bearing Head: named in the summary without a submission number
- (no number) Osteonics® Alumina Ceramic Bearing Head and Titanium Adaptor Sleeve Assembly: named in the summary without a submission number
- (no number) Osteonics® C-Taper Zirconia Ceramic Head: named in the summary without a submission number

## Most influential descendants
- K991952: Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts (1999), 20 descendants of its own
- K041940: Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral Heads (2005), 18 descendants of its own
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K990261: Plus Ceramic Head Prostheses (Alumina and Zirkonia) (1999), 9 descendants of its own
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own

## Indications for use
The indications for the use: of -these ceramic bearings; in keeping with those of other legally marketed Osteonics ceramic bearings, are as follows: For Use as a Bipolar Hip Replacement: Femoral head/neck fractures or non-unions. Aseptic necrosis of the femoral head. Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other Considerations: Pathological conditions or age considerations which indicate a more conservative acetabular procedure and in avoidance of the use of bone cement in the acetabulum. Salvage of failed total hip arthroplasty. For Use as a Total Hip Replacement: Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. Revision of previous cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

Source page: https://510kreport.com/device/K971409
Methodology: https://510kreport.com/methodology