# K962397: Statak Soft Tissue Attachment Device

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Aug 27, 1996 after 67 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: 1 generation back to K904436 (1990). 4 ancestors in all.
531 later devices descend from it; 4 cite it directly.
0 of 536 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926384: Statak & Mini-Statak Soft Tissue Attachment Device, Zimmer, Inc. (1993) 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.

## 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 - Bankart lesion repairs - SLAP lesion repairs - Acromio-clavicular separation repairs - Rotator cuff tear repairs - Capsular shift or capsulolabral reconstructions - Biceps tenodesis - Deltoid repairs Foot and Ankle - Medial or lateral instability repairs/reconstructions - Achilles tendon repairs/reconstructions - Midfoot reconstructions - Hallus valgus reconstructions Elbow, Wrist, and Hand Scapholunate ligament reconstructions 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 - Tliotibial band tenodesis - Patellar tendon repairs

Source page: https://510kreport.com/device/K962397
Methodology: https://510kreport.com/methodology