510(k) · Cleared
Recalled · Class II · 2025Prolene Polypropylene Nonabsorbable Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on Dec 6, 2013 as substantially equivalent to K946173 (ETHICON, Inc., 1995) after a 36-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it. It has been recalled 21 times.
- Decided
- Dec 6, 2013
- Review
- 36 days
- Class
- Class II
- Product code
- GAW
- Recalls
- 21
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946173 (1995). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK946173 Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide…ETHICON, Inc. · 1995 · Recalled
- This deviceK133356 Prolene Polypropylene Nonabsorbable SutureETHICON, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK160623 FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE -…M/s. Meril Endo Surgery Private Limited. · 2016
- Descendant · 2 generations on · 1 of its ownK172149 FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE -…M/s. Meril Endo Surgery Private Limited. · 2017
- Descendant · 3 generations on · 0 of its ownK231183 Non absorbable Surgical Polyester SutureShandong Haidike Medical Products Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK142639 StitchKitOrigami Surgical, LLC · 2014
Most influential descendants
Showing 4 of 4 · See all- K160623FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…M/s. Meril Endo Surgery Private Limited. · 2016 · cites it directly2descendants
- K172149FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable…M/s. Meril Endo Surgery Private Limited. · 2017 · 2 generations on1descendant
- K231183Non absorbable Surgical Polyester SutureShandong Haidike Medical Products Co., Ltd. · 2023 · 3 generations on0descendants
- K142639StitchKitOrigami Surgical, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946173 | Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene… | ETHICON, Inc. | 1995 | 10 |
| 0 (this device) | K133356 | Prolene Polypropylene Nonabsorbable Suture | ETHICON, Inc. | 2013 | — |
| +1 | K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non… | M/s. Meril Endo Surgery Private Limited. | 2016 | — |
| +2 | K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non… | M/s. Meril Endo Surgery Private Limited. | 2017 | — |
| +3 | K231183 | Non absorbable Surgical Polyester Suture | Shandong Haidike Medical Products Co., Ltd. | 2023 | — |
| +1 | K142639 | StitchKit | Origami Surgical, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GAW device
- #1 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional…score 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K946173 | Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly…Summary page 1…8.5010 Regulatory Class: 1I Product Code: GAW Predicate Devices: Labeling Changes for Generic Suture Types, by Ethicon Inc., K946 173, cleared January 9, 1995 PROLEN E Polypropylene Suture (Nonabsorba… | 1995 |
| * | — | PROLENE Polypropylene Suture (Nonabsorbable Surgical Suture, U.S.P., Type B) Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 7, 2025 | Class II | Z-1515-2025 | Process control | Identified curing issues with the silicone during the needles manufacturing process. |
| Dec 20, 2024 | Class II | Z-1096-2025 | Process control | 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 the patient and cause infection. |
| May 7, 2018 | Class II | Z-2451-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2454-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2456-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2459-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2452-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2450-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2464-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2457-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2465-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2448-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2466-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2461-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2463-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2455-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2462-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2453-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2458-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2460-2018 | Package design/selection | 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 injury to a healthcare professional… |
| May 7, 2018 | Class II | Z-2449-2018 | Package design/selection | 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 injury to a healthcare professional… |
The 5 latest of 21 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GAW devicesGAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GAW
1in 2024
2007high 3 (2012) · low 0 (2008)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · GAW
80in 2018
2007high 252 (2015) · low 36 (2013)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAW
2so far in 2026, the most since 2007
2007high 2 (2026) · low 0 (2008)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAW
2,545in 2025
2007high 2,545 (2025) · low 71 (2009)2025
MAUDE reports naming product code GAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 73 |
| 2008 | 0 | — | 0 | 75 |
| 2009 | 0 | — | 0 | 71 |
| 2010 | 2 | — | 0 | 85 |
| 2011 | 0 | — | 0 | 84 |
| 2012 | 3 | 86 | 0 | 194 |
| 2013 | 3 | 36 | 0 | 191 |
| 2014 | 2 | — | 0 | 437 |
| 2015 | 3 | 252 | 0 | 422 |
| 2016 | 1 | — | 0 | 440 |
| 2017 | 3 | 145 | 0 | 413 |
| 2018 | 3 | 80 | 0 | 685 |
| 2019 | 1 | — | 0 | 1,803 |
| 2020 | 2 | — | 0 | 1,493 |
| 2021 | 0 | — | 0 | 1,652 |
| 2022 | 2 | — | 0 | 1,563 |
| 2023 | 1 | — | 0 | 1,811 |
| 2024 | 1 | — | 0 | 2,348 |
| 2025 | 0 | — | 0 | 2,545 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
PROLENE™ suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133356 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133356: Prolene Polypropylene Nonabsorbable Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133356
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026