# K964532: Multitak SS Suture System

- Pathway: 510(k) (Traditional)
- Applicant: Bonutti Research
- Decided: Feb 3, 1997 after 83 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
No predicates in its family tree.
394 later devices descend from it; 2 cite it directly.
0 of 395 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Multitak SS Suture System: named in the summary without a submission number

## Most influential descendants
- K973015: Multitak SS Suture System (1997), 393 descendants of its own
- 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

## Indications for use
The devices are intended for soft tissue to bone suture fixation for the following indications: Shoulder - Rotator cuff tear repairs - Biceps tenodesis Foot and Ankle - Lateral instability repairs/reconstructions Elbow - Ulnar or radial collateral ligament reconstructions - Tennis elbow repair - Biceps tendon reattachment - Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament

Source page: https://510kreport.com/device/K964532
Methodology: https://510kreport.com/methodology