# K041940: Howmedica Osteonics Zirconia-Toughened-Alumina (Biolox Delta) Ceramic Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Feb 11, 2005 after 207 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: 2 generations back to K971409 (1997). 7 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 26 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 1.
- K991952: Osteonics Alumina C-Taper Head, Osteonics Trident Polyethylene Inserts, Howmedica Osteonics Corp. (1999) Summary page 1.
- K003391: Osteonics Alumina C-Taper Head, Howmedica Osteonics Corp. (2000) Summary page 1.
- K031803: Depuy Ceramic Femoral Heads, DePuy Orthopaedics, Inc. (2003) Summary page 1.

## 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

## Indications for use
The subject devices are single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper* hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene bearing surfaces. Indications for Use as a Bipolar • 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. • Pathological conditions or age considerations that indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum, * Salvage of failed total hip arthroplasty Indications for Use as a Total Hip: * Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis, * Revision of previous unsuccessful femoral head replacement, 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. * The term "C-Taper" includes both the original C-Taper design, and the modified C-Taper design first introduced on the hip stems found Substantially Equivalent via K982032

Source page: https://510kreport.com/device/K041940
Methodology: https://510kreport.com/methodology