# K982354: SD Trans-Osseous Fastener Models Tob 6 Bolt 32/50, Tob 6 Bolt 50/80, Tob 6 Bolt 80/140, Tob 6 Washer Models 12MM 16MM 1M

- Pathway: 510(k) (Traditional)
- Applicant: Special Devices, Inc.
- Decided: Nov 23, 1998 after 140 days
- Product code: HTN (Washer, Bolt Nut)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K130986: Frag-Loc System (2013), 0 descendants of its own

## Indications for use
Indications for use of the SD Trans-Osseous Fastener are for fastening fractured bone fragments together while the fracture heals. This fastener is specifically useful in fastening split fractures, such as found in tibial buttress fractures.

Source page: https://510kreport.com/device/K982354
Methodology: https://510kreport.com/methodology