# K961789: Resorbable Soft Tissue Attachment Device

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Aug 1, 1996 after 84 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Resorbable Soft Tissue Attachment Device manufactured by Zimmer: named in the summary without a submission number
- (no number) QuickAnchor™ manufactured by Mitek: named in the summary without a submission number
- (no number) Bio-Anchor™ Absorbable Suture Anchor manufactured by Linvatec: named in the summary without a submission number
- (no number) Statak® Soft Tissue Attachment Device manufactured by Zimmer: named in the summary without a submission number

## 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 separations 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 - Hallux 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 - Iliotibial band tenodesis - Patellar tendon repairs

Source page: https://510kreport.com/device/K961789
Methodology: https://510kreport.com/methodology