# K062408: Smith & Nephew Modular Femoral (Hemi) Head

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 12, 2006 after 26 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- 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 K896580 (1990). 3 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061243: Smith & Nephew Modular Femoral Head, Smith & Nephew, Inc. (2006) Summary page 1.
- K896580: Uni-Polar Head, Richards Medical Co., Inc. (1990) Summary page 1.

## Most influential descendants
- K093363: Cocr and Oxinium Femoral Heads and R3 Xlpe Liners (2010), 16 descendants of its own
- K113848: R3 Xlpe Liners (2012), 7 descendants of its own
- K161233: OXINIUM DH Fermoral Heads (2016), 6 descendants of its own
- K102370: R3 Xlpe Anteverted Liners (2011), 6 descendants of its own
- K191002: OR3O Dual Mobility System (2019), 5 descendants of its own

## Indications for use
The Smith & Nephew Modular Femoral Heads are indicated for the following: * Noninflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis; * rheumatoid arthritis; * arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis; * revision procedures where other treatments have failed; and * treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. The modular femoral heads are for single use only and are intended to be used as part of a hemi-hip replacement system when articulating against the natural acetabulum.

Source page: https://510kreport.com/device/K062408
Methodology: https://510kreport.com/methodology