# K091061: Implicitguide Surgical Suture System

- Pathway: 510(k) (Traditional)
- Applicant: Implicitcare, LLC
- Decided: Nov 13, 2009 after 213 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: 4 generations back to K014153 (2002). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001434: 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture, Genzyme Surgical Product (Genzyme Biosurgery) (2000) Summary page 1.
- K021019: Cottony II, Silky II Polydek & Tevdek II Polyester Suture, Genzyme Corp. (2002) Summary page 1.
- K041593: Featherlift Extended Length Aptos Thread, Surgical Specialties Corp (2004) Summary page 1.

## Most influential descendants
- K230510: MyEllevate (2023), 0 descendants of its own

## Indications for use
The Implicitguide TM Surgical Suture System is indicated for use in soft tissue approximation and elevation of subdermis and underlying muscle.

Source page: https://510kreport.com/device/K091061
Methodology: https://510kreport.com/methodology