# K133356: Prolene Polypropylene Nonabsorbable Suture

- Pathway: 510(k) (Special)
- Applicant: ETHICON, Inc.
- Decided: Dec 6, 2013 after 36 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K946173 (1995). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 1.
- (no number) PROLENE Polypropylene Suture (Nonabsorbable Surgical Suture, U.S.P., Type B): named in the summary without a submission number

## Most influential descendants
- K160623: FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture (2016), 2 descendants of its own
- K172149: FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture,  FILAPROP - Non Absorbable Polypropylene surgical Suture (2017), 1 descendant of its own
- K231183: Non absorbable Surgical Polyester Suture (2023), 0 descendants of its own
- K142639: StitchKit (2014), 0 descendants of its own

## Recalls of this device
- Mar 7, 2025 · Class II · Z-1515-2025: Identified curing issues with the silicone during the needles manufacturing process.
- Dec 20, 2024 · Class II · Z-1096-2025: Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to t
- May 7, 2018 · Class II · Z-2451-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2454-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2456-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2459-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2452-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2450-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2464-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2457-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2465-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2448-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2466-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2461-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2463-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2455-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2462-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2453-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2458-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2460-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju
- May 7, 2018 · Class II · Z-2449-2018: The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue inju

## Indications for use
PROLENE™ suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Source page: https://510kreport.com/device/K133356
Methodology: https://510kreport.com/methodology