# K061434: Trident Large Diameter Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 22, 2006 after 90 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955033 (1996). 13 ancestors in all.
54 later devices descend from it; 4 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021310: 36MM C-Taper Femoral Head Components (Lfit and Non-Lfit), Howmedica Osteonics Corp. (2002) Summary page 2.
- K022077: 36MM V40 Femoral Head Components (Lfit and Non-Lfit), Howmedica Osteonics Corp. (2002) Summary page 2.
- K993259: Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads, Sulzer Orthopedics, Inc. (2000) Summary page 2.
- K033716: Trident Acetabular System, Howmedica Osteonics Corp. (2005) Summary page 2.

## 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
- K093363: Cocr and Oxinium Femoral Heads and R3 Xlpe Liners (2010), 16 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

## Recalls of this device
- Sep 4, 2009 · Not classified · Z-0390-2010: Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.
- Sep 4, 2009 · Not classified · Z-0391-2010: Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.

## Indications for use
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/K061434
Methodology: https://510kreport.com/methodology