# K080778: Ensplint TM Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Sonoma Orthopedic Products, Inc.
- Decided: Jul 10, 2008 after 113 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 1.

## Indications for use
The EnsplintTM Bone Screws are intended to treat fractures of various small and long bones. The Ensplintrm Bone Screws can also be used with the EnsplintRx Distal Radius System.

Source page: https://510kreport.com/device/K080778
Methodology: https://510kreport.com/methodology