# K141263: Toggleloc and Juggerloc Implants/Instruments/Kits

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Nov 19, 2014 after 188 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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: 11 generations back to K911837 (1991). 118 ancestors in all.
No later device cites it as a predicate yet.
0 of 119 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 4.
- K110145: Biomet Sports Medicine Juggerknot Soft Anchor, Biomet, Inc. (2011) Summary page 4.
- K131035: Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM, Linvatec Corporation D/B/A Conmed Linvatec (2013) Summary page 4.

## Recalls of this device
- Feb 14, 2022 · Class II · Z-0809-2022: Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and
- 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 2.9 ToggleLoc and JuggerLoc Soft Tissue 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 Elbow Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment Knee Extracapsular repair: MCL, LCL, and posterior oblique ligament Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure

Source page: https://510kreport.com/device/K141263
Methodology: https://510kreport.com/methodology