# K153076: silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Jun 16, 2016 after 237 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: 2 generations back to K930738 (1994). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021019: Cottony II, Silky II Polydek & Tevdek II Polyester Suture, Genzyme Corp. (2002) Summary page 7.
- K001440: Nextstitch Cardiovascular Valve Suture, Genzyme Surgical Product (Genzyme Biosurgery) (2000) Summary page 7.
- K930738: Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc, Deknatel, Inc. (1994) Summary page 7.
- K802093: Gabbay-Frater Suture Guide, Howmedica Corp. (1980) Summary page 7.

## Most influential descendants
- K192490: Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch (2020), 1 descendant of its own
- K241111: AMT Suture Passer (2024), 0 descendants of its own
- K193530: Deklene MAXX (2020), 0 descendants of its own
- K162396: SILK Surgical Suture (2016), 0 descendants of its own

## Indications for use
NextStitch® cardiovascular valve suture are indicated for use for soft tissue approximation and/or ligation in cardiovascular valve replacement procedures. Polypropylene Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, and neurological procedures, but not for use in ophthalmic procedures. Nylon Surgical Suture is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological procedures. SILK Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. Stainless Steel Sutures are indicated for use in abdominal wound closure, hernia repair, sternal closure, and orthopedic procedures, including cerclage and tendon repair.

Source page: https://510kreport.com/device/K153076
Methodology: https://510kreport.com/methodology