# K991952: Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jun 29, 1999 after 19 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 K971409 (1997). 3 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971409: Osteonics Alumina C-Taper Head, Osteonics Corp. (1997) Summary page 2.
- K983382: Osteonics HA Generation II Acetabular Component System, Osteonics Corp. (1998) Summary page 2.
- K983502: Osteonics Secur-Fit AD Generation II Acetabular Component System, Osteonics Corp. (1998) Summary page 2.

## Most influential descendants
- 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
- 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

## Indications for use
The indications for the use of these ceramic bearing heads and polyethylene inserts are in keeping with those of other legally marketed Osteonics ceramic bearing heads and polyethylene inserts are as follows: Indications: Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. Revision of previously failed cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.

Source page: https://510kreport.com/device/K991952
Methodology: https://510kreport.com/methodology