510(k) · Cleared

Cleared

Proxifast Absorbable Staple

K132669510(k) TraditionalCleared Jan 13, 2014139-day reviewClass II21 CFR 878.4750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Surgimatix, Inc. · GDW Staple, Implantable

Cleared on Jan 13, 2014 as substantially equivalent to K090159 (Incisive Surgical, Inc., 2009) after a 139-day review. Its family tree reaches back 1 generation to 2009.

Decided: Jan 13, 2014
Review: 139 days
Class: Class II
Product code: GDW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K090159 (2009). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK090159 Insorb Absorbable Staple, Model 1020, 1025, and Other Product FamiliesIncisive Surgical, Inc. · 2009 · Recalled
This deviceK132669 Proxifast Absorbable StapleSurgimatix, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K090159	Insorb Absorbable Staple, Model 1020, 1025, and Other Product Families	Incisive Surgical, Inc.	2009	1
0 (this device)	K132669	Proxifast Absorbable Staple	Surgimatix, Inc.	2014	—

FIG. 1 — Lineage of K132669, 2009–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 GDW? 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 GDW device

#1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.0 · 14 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K090159	Insorb Absorbable Staple, Model 1020, 1025, and Other Product Families Summary page 1 …Device Classification: Class 11 3. Legally Marketed Predicate Devices for Claimed Equivalence: Name: INSORB Absorbable Staple 5 10(k) #: K090159 The Ethicon PDST" Barbed Suture (K 113004) is being referenced as a device made of polydioxanone. Therefore, the u…	Incisive Surgical, Inc.	2009	1
†	K113004	PDS (TM) Barbed Sutures	ETHICON, Inc.	2011	1

Also cleared against K090159: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
1 other device also cites its predicate K090159.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · GDW

3in 2025

2007high 15 (2014) · low 2 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDW

111in 2025

2007high 267 (2023) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GDW

3in 2025

2007high 22 (2009) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · GDW

11,905in 2025

2007high 16,600 (2019) · low 2,380 (2008)2025

MAUDE reports naming product code GDW, 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	8	56	9	2,401
2008	7	57	0	2,380
2009	13	27	22	4,014
2010	10	39	2	3,768
2011	11	49	9	3,826
2012	9	45	11 (1)	3,717
2013	13	49	1	3,777
2014	15	63	0	4,784
2015	8	111	6	4,899
2016	11	96	2	5,106
2017	13	103	3	11,643
2018	7	90	3	14,914
2019	12	205	4 (4)	16,600
2020	10	88	11	12,332
2021	9	233	0	13,015
2022	7	89	0	13,605
2023	4	267	1	14,623
2024	2	—	0	13,280
2025	3	111	3	11,905
2026	3	141	0	—

What is it indicated for?

Surgimatix PruxiFast Absorbable Staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subtuticular closure of skin with an approximate thickness of I to 5 mm where an absorbable tissue fastener is desired for temporary tissue approximation.

The device is not indicated for use in shallow or very small incisions, and is not indicated far final closure of the terminal 2 cm of incisions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132669 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132669: Proxifast Absorbable Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132669

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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