# K083070: Toggleloc System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Sports Medicine
- Decided: Dec 16, 2008 after 62 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K792022 (1979). 43 ancestors in all.
94 later devices descend from it; 11 cite it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS, Arthrex, Inc. (2005) Summary page 1.
- K071704: Sleeve and Button Soft Tissue Devices, Biomet Sports Medicine, Inc. (2007) Summary page 1.
- K033838: Titanium Toggle Button (S), Biomet Manufacturing, Inc. (2004) Summary page 1.

## Most influential descendants
- K123341: Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex Proximal Biceps Button (2012), 52 descendants of its own
- K150768: JuggerKnot Soft Anchors (2015), 40 descendants of its own
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to (2013), 35 descendants of its own
- K180768: Arthrex SwiveLock Anchors (2018), 28 descendants of its own
- K191226: Arthrex SwiveLock Suture Anchor (2019), 21 descendants of its own

## Recalls of this device
- Aug 22, 2017 · Class II · Z-0818-2018: Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors.
- Apr 1, 2016 · Class II · Z-1828-2016: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non
- Mar 31, 2010 · Not classified · Z-1952-2010: The firm has received complaints that the saddle is too long. The saddle is supposed to be between 7/8 and 1 1/8 inches long. The saddle in the complaints was up to 1.9 inches long.
- Mar 31, 2010 · Not classified · Z-1953-2010: The firm has received complaints that the saddle is too long. The saddle is supposed to be between 7/8 and 1 1/8 inches long. The saddle in the complaints was up to 1.9 inches long.
- Nov 10, 2009 · Not classified · Z-0560-2010: Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa.
- Nov 10, 2009 · Not classified · Z-0559-2010: Packages labeled as containing a stainless steel device actually contain a titanium device, and vice versa.

## Indications for use
The ToggleLocTM System Devices are intended for soft tissue to bone fixation for the following indications: Shoulder: Bankart lesion repair, SLAP lesion repairs Acromio-davicular 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 Band C ankle fractures (only for ToggieLoc" with Tophat) Elbow: Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment Knee: ACL/PCLrepair / 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 HiM Acetabular labral repair

Source page: https://510kreport.com/device/K083070
Methodology: https://510kreport.com/methodology