# K022952: Modular Head Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 2, 2002 after 88 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K922322 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013534: Self-Countersinking Bone Screw, Biomet Orthopedics, Inc. (2001) Summary page 1.
- K962823: Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer, Synthes (Usa) (1996) Summary page 1.

## Indications for use
The indications for the use of the Modular Head Bone Screw include: Fixation of fractures in long bones such as the fibula, tibia, humerus, radius and ulna, as well as fractures in the patella Fixation of small bones such as those in the foot, ankle, wrist and elbow Ligament reconstruction Arthrodesis of the foot, ankle, wrist and elbow Small bone osteotomies Osteochondritis dissecans

Source page: https://510kreport.com/device/K022952
Methodology: https://510kreport.com/methodology