# K120540: Biobolt

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Mar 20, 2012 after 26 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- 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: 7 generations back to K971358 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093912: Arthrex Tibial Graftbolt, Arthrex, Inc. (2010) Summary page 1.
- K103060: Arthrex Tibial Graftbolt, Arthrex, Inc. (2011) Summary page 1.

## Indications for use
The Arthrex BioComposite GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone during cruciate ligament reconstruction procedures.

Source page: https://510kreport.com/device/K120540
Methodology: https://510kreport.com/methodology