# K110145: Biomet Sports Medicine Juggerknot Soft Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Mar 4, 2011 after 45 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: 4 generations back to K904436 (1990). 14 ancestors in all.
83 later devices descend from it; 10 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071704: Sleeve and Button Soft Tissue Devices, Biomet Sports Medicine, Inc. (2007) Summary page 1.

## Most influential descendants
- K150768: JuggerKnot Soft Anchors (2015), 40 descendants of its own
- K111779: Y-Knot All-Suture Anchor Model HF13 (2011), 29 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
- K131035: Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM (2013), 17 descendants of its own

## Recalls of this device
- Aug 3, 2018 · Class II · Z-3252-2018: Expiration date incorrectly listed on the label
- 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
- Jul 21, 2011 · Not classified · Z-3109-2011: The device packaging was punctured by the device, resulting in loss of implant sterility.

## Indications for use
The JuggerKnot TM Soft Anchors are intended for soft tissue to bone flxation for the following indications: Shoulder Bankart lesion repair, SLAP lesion repair, 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 Extra-capsular 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

Source page: https://510kreport.com/device/K110145
Methodology: https://510kreport.com/methodology