# K123485: Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors with Needles, Juggerknotless Sof

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Sports Medicine
- Decided: Mar 18, 2013 after 125 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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: 5 generations back to K943806 (1995). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080088: Biomet Sports Medicine Anchor Devices and Ziploop Constructs, Biomet Manufacturing, Inc. (2008) Summary page 1.
- K110145: Biomet Sports Medicine Juggerknot Soft Anchor, Biomet, Inc. (2011) Summary page 1.

## Recalls of this device
- 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
- Oct 10, 2013 · Class II · Z-0364-2014: Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. The implant may skip across the hole or miss the hole during insertion.

## Indications for use
The JuggerKnotlessTM Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific indications are as follows: Shoulder Acmomio-clavicular Separation, Anterior Shoulder Instability Repair, Bankart lesion repair, Biceps tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs Foot and Ankle Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot/Forefoot Reconstruction/Repairs Elbow Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral/Medial Repairs, Lateral Epicondylitis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction Knee Iliotibial Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Ligament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment/Repair, Posterior Oblique Ligament Repair, VMO Advancement Hand and Wrist Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers in Phalanx, Volar Plate Reconstruction Hip Labral

Source page: https://510kreport.com/device/K123485
Methodology: https://510kreport.com/methodology