# K961157: Whiteside Biomechanics Cancellous Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Whiteside Biomechanics, Inc.
- Decided: May 17, 1996 after 56 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K121682: Active Screw Bone Screw (2012), 0 descendants of its own

## Indications for use
This bone fixation screw is intended for human implantation into prepared bone during orthopedic surgery when the surgeon determines the need for additional fixation (example: fixation of acetabular cup in total hip replacement, fracture fixation, tibial tray fbation, etc.). There is a broad spectrum of uses for this device and the specific use should be determined by the surgeon using sound medical judgment.

Source page: https://510kreport.com/device/K961157
Methodology: https://510kreport.com/methodology