# K983495: Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, Model#'S 222020-248120, 240050-240980, 241130-246620, 4240420

- Pathway: 510(k) (Traditional)
- Applicant: Syntec Scientific Corp.
- Decided: Dec 16, 1998 after 72 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.
84 later devices descend from it; 11 cite it directly.
0 of 85 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 its predicate without a number.
- (no number) Synthes bone plate and bone screw: named in the summary without a submission number

## Most influential descendants
- K063020: Intai Bone Plate and Bone Screw System; Intai DHS/DCS Plate System (2006), 29 descendants of its own
- K072562: Microware Bone Plates and Bone Screws (2008), 25 descendants of its own
- K170518: In2Bones Fracture and Correction System (2017), 15 descendants of its own
- K181113: CoLink™ Afx Plating System (2018), 14 descendants of its own
- K092493: GPC Bone Plaes and Bone Screw & GPC DHS/DCS Plate System (2010), 14 descendants of its own

## 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/K983495
Methodology: https://510kreport.com/methodology