# K173278: ToggleLoc System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jan 5, 2018 after 84 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: 9 generations back to K904436 (1990). 61 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to, Biomet Manufacturing Corp (2013) Summary page 5.

## Most influential descendants
- K240035: TACTIX Vector Syndesmosis System (2024), 1 descendant of its own
- K243408: TACTIX Vector Syndesmosis System (2024), 0 descendants of its own
- K240947: TENSOR®  Suture Button System (2024), 0 descendants of its own

## Indications for use
The ToggleLoc System devices, except the ToggleLoc XL device, are intended for soft tissue to bone fixation for the following indications: Shoulder Bankart lesion repair SLAP lesion repairs Acromio-clavicular repair Capsular shift/capsulolabral reconstruction Deltoid repair Rotator cuff tear repair Biceps Tenodesis Foot and Ankle Medial/lateral repair and reconstruction Mid- and forefoot repair Hallux valgus reconstruction Metatarsal ligament/tendon repair or reconstruction Achilles tendon repair Ankle Syndesmosis fixation (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures (only for ToggleLoc with Tophat/ZipTight Fixation Devices) Elbow Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment Knee ACL/PCL repair / reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction Extracapsular repair: MCL, LCL, and posterior oblique ligament Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure Hand and Wrist Collateral ligament repair Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction The ToggleLoc XL device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures, such as Anterior Cruciate (ACL) or Posterior Cruciate (PCL) Reconstruction, as well as fixation in cases of unanticipated intraoperative complications, such as cortical breaching.

Source page: https://510kreport.com/device/K173278
Methodology: https://510kreport.com/methodology