# K130986: Frag-Loc System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Jul 23, 2013 after 105 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
Longest line of descent: 1 generation back to K982354 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Special Devices, Inc. (1998) Summary page 1.

## Indications for use
The Frag-Loc®&System is intended to provide compression to bones and bone fragments for the fixation of fractures, fusions, or osteotomies.

Source page: https://510kreport.com/device/K130986
Methodology: https://510kreport.com/methodology