# K103145: Hammerloc TM Tibial Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Sports Medicine
- Decided: Feb 9, 2011 after 107 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K943806 (1995). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041274: Resorbable Interference Screw, Arthrotek, Inc. (2004) Summary page 1.
- K982497: Arthrotek Interference Screw, Biomet, Inc. (1998) Summary page 1.
- K083607: Aperfix Implant with Inserter, 8, 9, 10, 11, MM X30 MM, Cayenne Medical, Inc. (2009) Summary page 1.
- K983560: Innovasive Devices Intratunnel Tibial Fixation Fastener, Innovasive Devices, Inc. (1999) Summary page 1.

## Most influential descendants
- K193092: TunneLoc Tibial Fixation Device (2020), 0 descendants of its own

## Recalls of this device
- Oct 11, 2017 · Class II · Z-1071-2018: Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
- Oct 11, 2017 · Class II · Z-1072-2018: Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.

## 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/K103145
Methodology: https://510kreport.com/methodology