# K070885: Universal Taper Delta Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: May 16, 2007 after 47 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.
54 later devices descend from it; 4 cite it directly.
0 of 55 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 no predicate by number.

## Most influential descendants
- K110290: Exeter Hip Stem (2011), 37 descendants of its own
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K071830: Depuy Delta TS Ceramic Femoral Heads (2007), 14 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

## Indications for use
The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures. 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.

Source page: https://510kreport.com/device/K070885
Methodology: https://510kreport.com/methodology