# K103060: Arthrex Tibial Graftbolt

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Jan 5, 2011 after 79 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: 6 generations back to K971358 (1997). 10 ancestors in all.
2 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)
- K093912: Arthrex Tibial Graftbolt, Arthrex, Inc. (2010) Summary page 1.

## Most influential descendants
- 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/K103060
Methodology: https://510kreport.com/methodology