# K150376: Sonoma Cancellous Bone Screw and Washer

- Pathway: 510(k) (Traditional)
- Applicant: Sonoma Orthopedics Products, Inc.
- Decided: Jun 12, 2015 after 119 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: 1 generation back to K983495 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983495: Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120, 240050-240980, 241130-246620, 4240420, Syntec Scientific Corp. (1998) Summary page 5.

## Indications for use
The Sonoma Cancellous Screws are intended for use in the fixation of bone fractures appropriate for the size of the screw. The washer is used to increase bone contact area and prevent the screw head from subsiding into the bone. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K150376
Methodology: https://510kreport.com/methodology