# K143582: Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel

- Pathway: 510(k) (Traditional)
- Applicant: Resorba Medical GmbH
- Decided: Oct 29, 2015 after 315 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- 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 K961555 (1996). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980703: Premilene Nonabsorbable Polypropylene Surgical Suture, Aesculap, Inc. (1998) Summary page 4.
- K001625: Pronova Nonabsorbable Suture, Usp, ETHICON, Inc. (2000) Summary page 4.
- K990089: Silkam Nonabsorbable Silk Surgical Suture, Aesculap, Inc. (1999) Summary page 4.
- K100006: HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/Need, Riverpoint Medical (2010) Summary page 4.
- K080684: WG-Surgical Sutures with Needle, Foosin Medical Supplies, Inc. (2008) Summary page 4.
- K021019: Cottony II, Silky II Polydek & Tevdek II Polyester Suture, Genzyme Corp. (2002) Summary page 4.
- K981582: Surgilon, Dermalon, & Ophthalon, Davis & Geck, Inc. (1998) Summary page 4.
- K913102: Peters Cardionyl (TM) Suture, Promedica Products, Inc. (1992) Summary page 5.
- K904052: Supramid Extra Sutures, S. Jackson, Inc. (1990) Summary page 5.
- K955723: Stainless Steel Sutures, Flexon Steel Sutures (Stainless), Davis & Geck, Inc. (1996) Summary page 5.
- K140127: Ferrofibre Stainless Steel Suture with Crimp, Pontis Orthopaedics, LLC (2014) Summary page 5.
- K030351: Stainless Steel Surgical Suture, Non-Absorbable, Cp Medical (2003) Summary page 5.

## Indications for use
Each non-absorbable suture is used as a surgical suture to support wound closure/soft tissue approximation, with the following indications: Except Steel, each non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures*. *MOPYLEN is also indicated for microsurgery * POLYESTER is also indicated for orthopaedic surgery *RESOLON is also indicated for microsurgery Steel wire is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.

Source page: https://510kreport.com/device/K143582
Methodology: https://510kreport.com/methodology