# K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Aug 1, 2013 after 209 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904436 (1990). 60 ancestors in all.
35 later devices descend from it; 17 cite it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083070: Toggleloc System, Biomet Sports Medicine (2008) Summary page 1.
- K102982: Endobutton Direct, Smith & Nephew Inc., Endoscopy Division (2011) Summary page 1.
- K112990: Acl Tightrope,Acl Tightrope Duuble Bundle, Arthrex, Inc. (2011) Summary page 1.

## Most influential descendants
- K231857: Arthrex TightRope II (2023), 4 descendants of its own
- K241235: Arthrex TightRope II (2024), 3 descendants of its own
- K211770: R3ACT Stabilization System (2021), 3 descendants of its own
- K173278: ToggleLoc System (2018), 3 descendants of its own
- K223589: Grappler Suture Anchor R3FLEX IOL System (2023), 2 descendants of its own

## Recalls of this device
- Sep 23, 2025 · Class II · Z-0212-2026: There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
- Aug 22, 2017 · Class II · Z-0818-2018: Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors.
- Feb 26, 2015 · Class II · Z-1363-2015: The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not b

## Indications for use
The ToggleLoc System devices, except the ToggleLoc XTender and ToggleLoc XL devices, 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 Cankle fractures (only for ToggleLoc with ZipTight) 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 Iliotibial 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 Hip Acetabular labral repair The ToggleLoc XTender device is used for fixation of tendons and ligaments in cases of unanticipated intraoperative complications such as cortical breaching during orthopedic reconstruction procedures, such as Anterior Cruciate (ACL) or Posterior Cruciate (PCL) Reconstruction. The ToggleLoc XTender is for use in conjunction with a titanium alloy ToggleLoc device, excluding the ToggleLoc XL devices.

Source page: https://510kreport.com/device/K130033
Methodology: https://510kreport.com/methodology