# K013177: Multitak Suture Snap System

- Pathway: 510(k) (Traditional)
- Applicant: Bonutti Research, Inc.
- Decided: Dec 19, 2001 after 86 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- 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) Axya Medical, Inc., Suture Welding System and Kit: named in the summary without a submission number
- (no number) Innovasive Devices, Inc., Y-Knot Suture Clip: named in the summary without a submission number
- (no number) Mitek BTB Absorbable (PLA) Cross Pin: named in the summary without a submission number
- (no number) Genzyme Surgical Products, Inc., nonabsorbable suture: named in the summary without a submission number

## Indications for use
The intended use of the Multitak Suture Snap System is in general soft tissue approximation and/or ligation. The system is indicated in securing soft tissue in arthroscopic and open surgical procedures where USP Size No. 2-0 through Size 2 nonabsorbable suture is used.

Source page: https://510kreport.com/device/K013177
Methodology: https://510kreport.com/methodology