# K090839: Modification to Syntec-Taichun Non-Sterile Bone Plate and Screw Implants

- Pathway: 510(k) (Special)
- Applicant: Syntec Scientific Corp.
- Decided: Apr 24, 2009 after 28 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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.
- (no number) Syntec-Taichung Bone Plates and Screw Implant: named in the summary without a submission number

## Indications for use
The bone plates and screws are provided non-sterile. The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).

Source page: https://510kreport.com/device/K090839
Methodology: https://510kreport.com/methodology