# K193092: TunneLoc Tibial Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jan 2, 2020 after 57 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: 4 generations back to K943806 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103145: Hammerloc TM Tibial Fixation Device, Biomet Sports Medicine (2011) Summary page 4.

## Indications for use
To provide fixation of soft-tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.

Source page: https://510kreport.com/device/K193092
Methodology: https://510kreport.com/methodology