# K984543: Syntec-Taichung Non-Sterile Interlocking Nail System, Model:Humerus:256-000/280, Femur:274-000/870, Tibia:249-300/420 25

- Pathway: 510(k) (Traditional)
- Applicant: Syntec Scientific Corp.
- Decided: Mar 1, 1999 after 70 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 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) Richards — Trimax Nail System: named in the summary without a submission number

## Most influential descendants
- K181296: Syntec Femoral Nail System (2019), 2 descendants of its own
- K202935: Syntec Femoral Nail Extended System (2020), 0 descendants of its own
- K191617: Syntec Tibial Nail System (2019), 0 descendants of its own

## Indications for use
The Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(humerus, femur, and tibia) for the fixation of fractures.

Source page: https://510kreport.com/device/K984543
Methodology: https://510kreport.com/methodology