# K092889: Syntec Osteo-Plate and Screw Fixation

- Pathway: 510(k) (Traditional)
- Applicant: Syntec Scientific Corp.
- Decided: Jun 25, 2010 after 277 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.
13 later devices descend from it; 3 cite it directly.
0 of 15 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.

## Most influential descendants
- K130108: Double Engine Bone Plate and Screw Systems (2013), 9 descendants of its own
- K221150: Advanced Bone Plate (2023), 1 descendant of its own
- K221088: Anatomic Bone Plate (2023), 1 descendant of its own
- K220921: Metal Bone Screw (2022), 1 descendant of its own
- K112819: Reconstruction Locking Plate and 3.5MM Locking Screw (2011), 1 descendant of its own

## Indications for use
Syntec Osteo-plate and screw Fixation is intended to be used on small bones or large bones for fracture fixation, including the fractures of clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).

Source page: https://510kreport.com/device/K092889
Methodology: https://510kreport.com/methodology