# K021310: 36MM C-Taper Femoral Head Components (Lfit and Non-Lfit)

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: May 21, 2002 after 26 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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 K900836 (1990). 3 ancestors in all.
55 later devices descend from it; 2 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910988: Osteonics Ion Implanted Femoral Bearing Series, Osteonics Corp. (1991) Summary page 1.
- K900836: Osteonics Ecsi Hip Stem Series, Osteonics Corp. (1990) Summary page 1.
- K982936: Osteonics Extended Femoral Bearing Head, Osteonics Corp. (1998) Summary page 1.

## Most influential descendants
- K061434: Trident Large Diameter Hip System (2006), 54 descendants of its own
- 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

## Indications for use
Indications for use as part of a Universal Hip Replacement include: • Femoral neck fractures; • Non-union of femoral head and neck fractures, • Aseptic necrosis of the femoral head as well as; • Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Indications for use as part of a Total Hip Replacement include: • Severely disabled joints resulting from painful osteo-, rheumatoid, post-traumatic arthritis and late stages of avascular necrosis; • Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure as well as; • Other difficult clinical management problems.

Source page: https://510kreport.com/device/K021310
Methodology: https://510kreport.com/methodology