# K983988: Syntec-Taichung Non-Sterile Titanium Alloy Mini-Plate

- Pathway: 510(k) (Traditional)
- Applicant: Syntec Scientific Corp.
- Decided: Jan 27, 1999 after 79 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
No predicates in its family tree.
30 later devices descend from it; 3 cite it directly.
0 of 31 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 no predicate by number.

## Most influential descendants
- K023360: Leforte System Bone Plate (2002), 20 descendants of its own
- K131311: Arix Foot System (2013), 9 descendants of its own
- K050669: Jeil Bone Fixation System (2005), 8 descendants of its own
- K022139: Hip Tool Implant (2002), 7 descendants of its own
- K161864: ARIX Foot System (2016), 5 descendants of its own

## Indications for use
The titanium alloy Mini plate is provided non-sterile. The device is intended to treat fractures of various bones, including the clavicle, scapula, pelvis, calcaneus, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).

Source page: https://510kreport.com/device/K983988
Methodology: https://510kreport.com/methodology