# K993115: Multitak SS

- Pathway: 510(k) (Traditional)
- Applicant: Bonutti Research, Inc.
- Decided: Dec 17, 1999 after 88 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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). 8 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 13 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 2.

## Most influential descendants
- K011985: Smith & Nephew Phoenix 5.0 Allograft Anchor Kit (2001), 3 descendants of its own
- K042038: MTF Allograft Anchor (2004), 1 descendant of its own
- K061498: Allofix Anchor, 5.0 MM Anchor (2006), 0 descendants of its own
- K053339: Allofix Anchor (2006), 0 descendants of its own

## Indications for use
Multitak SS™ bone anchors are intended for use as a load bearing or non-load bearing suture anchor used in the attachment of soft tissue to bone in various orthopedic procedures. Multitak SS™ bone anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications: Shoulder: Bankart lesion repairs S.L.A.P. lesions repairs Acromio-clavicular repairs Capsular shift/capsulolabral reconstruction Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Elbow: Biceps tendon reattachment Tennis elbow repair Ulnar or radial collateral ligament reconstruction Knee: Extra-capsular repairs Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure Foot/Ankle: Medial/Lateral repairs/reconstructions Achilles tendon repairs Midfoot and forefoot repairs Hallus valgus reconstruction Hand/Wrist: Collateral ligament repair (Gamekeeper’s Thumb) Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction

Source page: https://510kreport.com/device/K993115
Methodology: https://510kreport.com/methodology