# K973015: Multitak SS Suture System

- Pathway: 510(k) (Traditional)
- Applicant: Bonutti Research
- Decided: Oct 9, 1997 after 57 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: 2 generations back to K904436 (1990). 7 ancestors in all.
393 later devices descend from it; 5 cite it directly.
0 of 401 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934183: Bonutti Anchor, Apogee Medical Products, Inc. (1996) Summary page 1.
- K964532: Multitak SS Suture System, Bonutti Research (1997) Summary page 1.
- K926384: Statak & Mini-Statak Soft Tissue Attachment Device, Zimmer, Inc. (1993) Summary page 1.
- K962397: Statak Soft Tissue Attachment Device, Zimmer, Inc. (1996) Summary page 1.

## Most influential descendants
- K990156: Multitak SS Buttons (1999), 336 descendants of its own
- K033717: Transet Fracture Fixation System (2004), 309 descendants of its own
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS (2005), 306 descendants of its own
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD (2005), 217 descendants of its own
- K031666: Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS (2003), 161 descendants of its own

## Indications for use
The Multitak Suture System is intended for soft tissue to bone suture fixation for the following indications: Shoulder Bankart lesion repairs S.L.A.P. lesion repairs Acromio-clavicular repairs Capsular shift/capsulolabral reconstruction Deltoid repair Rotator cuff tear repairs Biceps tenodesis Knee Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Iliotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure Foot and Ankle Medial/lateral repairs, reconstructions Achilles tendon repairs Midfoot and forefoot repairs Hallux valgus reconstruction Hand/Wrist Collateral ligament repair (Gamekeeper's Thumb) Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction Elbow Ulnar or radial collateral ligament reconstructions Tennis elbow repair Biceps tendon reattachment

Source page: https://510kreport.com/device/K973015
Methodology: https://510kreport.com/methodology