# K101252: Neotract Anchor System Model: Ref 11208

- Pathway: 510(k) (Traditional)
- Applicant: Neotract, Inc.
- Decided: Jul 15, 2010 after 72 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K972679 (1997). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073651: Neotract Anchor System, Neotract, Inc. (2008) Summary page 1.
- K021019: Cottony II, Silky II Polydek & Tevdek II Polyester Suture, Genzyme Corp. (2002) Summary page 1.
- K073644: Endogastric Solutions Stomaphyx  Device and Accessories, Endogastric Solutions, Inc. (2008) Summary page 1.

## Most influential descendants
- K102028: Neotract Anchor System Model TAS400 (2010), 0 descendants of its own

## Indications for use
The Modified NeoTract Anchor System is intended for the approximation of tissue in open surgical procedures.

Source page: https://510kreport.com/device/K101252
Methodology: https://510kreport.com/methodology