# K093912: Arthrex Tibial Graftbolt

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Mar 18, 2010 after 86 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K971358 (1997). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032167: Bio-Intrafix Tibial Screw and Sheath, Mitek Worldwide (2003) Summary page 1.
- K083607: Aperfix Implant with Inserter, 8, 9, 10, 11, MM X30 MM, Cayenne Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K103060: Arthrex Tibial Graftbolt (2011), 2 descendants of its own
- K253130: Dione PEEK Screw System (2026), 0 descendants of its own
- K120540: Biobolt (2012), 0 descendants of its own

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

Source page: https://510kreport.com/device/K093912
Methodology: https://510kreport.com/methodology