# K101063: Sleeve with Ziploop Fixation Devices

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Sports Medicine
- Decided: Jun 23, 2010 after 68 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (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.
3 later devices descend from it; 1 cites it directly.
0 of 18 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.
- K973015: Multitak SS Suture System, Bonutti Research (1997) Summary page 1.
- K053344: Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor, Smith & Nephew, Inc. (2006) Summary page 1.

## Most influential descendants
- K110473: Nanotack Suture Anchor 1.4MM (2011), 2 descendants of its own
- K130351: Nanotack Suture Anchor 1.4MM with Flex Inserter (2013), 0 descendants of its own
- K123651: Cinchlock Knotless Suture Anchor (2013), 0 descendants of its own

## Recalls of this device
- Feb 26, 2015 · Class II · Z-1364-2015: 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 Sleeve with ZipLoopTm Fixation Devices are intended for fixation 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 reconstrudtion, Tendon transfers in phalanx, Volar plate reconstruction Hip Acetabular labral repair

Source page: https://510kreport.com/device/K101063
Methodology: https://510kreport.com/methodology