# K071704: Sleeve and Button Soft Tissue Devices

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Sports Medicine, Inc.
- Decided: Sep 17, 2007 after 88 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904436 (1990). 13 ancestors in all.
142 later devices descend from it; 4 cite it directly.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K813581: Cruciate Ligament Button, Biomet, Inc. (1982) Summary page 1.

## Most influential descendants
- K083070: Toggleloc System (2008), 94 descendants of its own
- K110145: Biomet Sports Medicine Juggerknot Soft Anchor (2011), 83 descendants of its own
- K123341: Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex Proximal Biceps Button (2012), 52 descendants of its own
- K150768: JuggerKnot Soft Anchors (2015), 40 descendants of its own
- K130033: Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB, Extended Toggleloc; Toggleloc; BTB to (2013), 35 descendants of its own

## Indications for use
The Sleeve and Button Soft Tissue Devices utilizing ZipLoop TM Technology are intended for soft tissue to bone 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 ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction Hip Acetabular labral repair In addition to the aforementioned indications, the Button Soft Tissue Devices (all sizes) and size specific Sleeve Soft Tissue Devices (as shown in Table 1) are indicated for the following: Knee ACL/PCL repair/reconstruction ACL/PCL patellar bone-tendon-bone grafts Double-Tunnel ACL reconstruction

Source page: https://510kreport.com/device/K071704
Methodology: https://510kreport.com/methodology