# K061243: Smith & Nephew Modular Femoral Head

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 17, 2006 after 75 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896580 (1990). 2 ancestors in all.
19 later devices descend from it; 2 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)
- K896580: Uni-Polar Head, Richards Medical Co., Inc. (1990) Summary page 1.
- K023743: Smith & Nephew Global Bipolar System, Smith & Nephew, Inc. (2003)

## Most influential descendants
- K062408: Smith & Nephew Modular Femoral (Hemi) Head (2006), 18 descendants of its own
- 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

## Recalls of this device
- Nov 16, 2015 · Class II · Z-0584-2016: The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing in the US. The actual devices were monobl

## 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/K061243
Methodology: https://510kreport.com/methodology