# K971144: Multitak SS Suture System

- Pathway: 510(k) (Traditional)
- Applicant: Bonutti Research
- Decided: Jun 25, 1997 after 89 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.
- K953877: Mitek Gii Anchor, Mitek Surgical Products, Inc. (1995) Summary page 1.
- K930892: Mitek Mini Anchor, Modification, Mitek Surgical Products, Inc. (1994) Summary page 1.
- K904436: Quickanchor (TM), Mitek Surgical Products, Inc. (1990) 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.

## Indications for use
The devices are 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 Foot and Ankle - Medial/lateral repairs, reconstructions - Achilles tendon repairs - Midfoot and forefoot repairs - Hallux Valgus reconstruction Elbow - Ulnar or radial collateral ligament reconstructions - Tennis elbow repair - Biceps tendon reattachment Knee - Extra-capsular repairs: Medial collateral-ligament Lateral collateral ligament Posterior oblique ligament - Iliotibial band tenodesis - Patellar tendon repair - VMO advancement - Joint capsule closure Hand/Wrist - Collateral ligament repair (Gamekeeper's Thumb) - Scapholunate ligament reconstruction - Tendon transfers in phalanx - Volar plate reconstruction

Source page: https://510kreport.com/device/K971144
Methodology: https://510kreport.com/methodology