510(k) · Cleared

Recalled · Class II · 2015

Insorb Absorbable Staples, Model SP-B20

K024117510(k) TraditionalCleared Apr 22, 2003130-day reviewClass II21 CFR 878.4750Recalls 1

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

Incisive Surgical, Inc. · GDW Staple, Implantable

Cleared on Apr 22, 2003 as substantially equivalent to K915489 (United States Surgical, A Division of Tyco Healthc, 1992) and 4 other predicates after a 130-day review. Its family tree reaches back 1 generation to 1992. 68 later devices descend from it. It has been recalled once.

Decided: Apr 22, 2003
Review: 130 days
Class: Class II
Product code: GDW
Recalls: 1
Predicates: 5

Its longest line of descent runs back 1 generation to K915489 (1992). 5 ancestors in all. 68 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK915489 Auto Suture Absorable Subcuticular Closure StapleUnited States Surgical, A Division of Tyco Healthc · 1992
This deviceK024117 Insorb Absorbable Staples, Model SP-B20Incisive Surgical, Inc. · 2003
Descendant · cites it directly · 64 of its ownK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
Descendant · 2 generations on · 31 of its ownK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
Descendant · 2 generations on · 30 of its ownK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
Descendant · 2 generations on · 29 of its ownK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
Descendant · 2 generations on · 26 of its ownK072028 Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2003high 6 (2012) · low 0 (2004)2026

Most influential descendants

Showing 5 of 68 · See all

K051609Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005 · cites it directly64descendants
K071989Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialSurgical Specialties Corp · 2007 · 2 generations on31descendants
K080680Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008 · 2 generations on30descendants
K080985Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008 · 2 generations on29descendants
K072028Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007 · 2 generations on26descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K915489	Auto Suture Absorable Subcuticular Closure Staple	United States Surgical, A Division of Tyco Healthc	1992	—
0 (this device)	K024117	Insorb Absorbable Staples, Model SP-B20	Incisive Surgical, Inc.	2003	—
+1	K051609	Quill Synthetic Absorbable Barbed Suture	Quill Medical, Inc.	2005	—
+2	K071989	Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material	Surgical Specialties Corp	2007	—
+2	K080680	Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone	Surgical Specialties Corp	2008	—
+2	K080985	Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)	Surgical Specialties Corp	2008	—
+2	K072028	Quill Self-Retaining System (SRS) Comprised of Monoderm	Surgical Specialties Corp	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1996	1	0
1998	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	4	0
2006	2	0
2007	2	0
2008	3	0
2009	1	0
2010	1	0
2011	1	0
2012	6	0
2013	6	0
2014	3	0
2015	4	0
2016	2	0
2017	1	0
2018	4	0
2019	6	0
2020	4	0
2021	3	0
2022	3	0
2023	1	0
2024	4	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K024117, 1992–2026Source: 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? (5)

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
*	K915489	Auto Suture Absorable Subcuticular Closure Staple Summary page 1 …stantially equivalent to the Autosuture Absorbable Subcuticular Closure Staplt: manufactured by United States Surgical (K9 15489), the Proximate Absorbable Staple manufactured by Ethicon Inc. (K915693), and V…	United States Surgical, A Division of Tyco Healthc	1992	—
*	K915693	Proximate Absorbable Staples Summary page 1 …taplt: manufactured by United States Surgical (K9 15489), the Proximate Absorbable Staple manufactured by Ethicon Inc. (K915693), and Vicryl Synthetic Absorbable Suture which are also manufactured by Ethicon…	ETHICON, Inc.	1992	—
*	K022269	Coated Vicryl* (Polyglactin 910) Suture Summary page 1 …. (K915693), and Vicryl Synthetic Absorbable Suture which are also manufactured by Ethicon Inc. (Multiple 5 1O(k)'s e.g K022269, K974299, IC962480). DEVICE DESCRIPTION: INSORBTMAbsorbable Staples are 5. lmm in length, 0..79mm…	ETHICON, Inc.	2002	3
*	K974299	Panacryl Summary page 1 …3), and Vicryl Synthetic Absorbable Suture which are also manufactured by Ethicon Inc. (Multiple 5 1O(k)'s e.g K022269, K974299, IC962480). DEVICE DESCRIPTION: INSORBTMAbsorbable Staples are 5. lmm in length, 0..79mm…	ETHICON, Inc.	1998	1
*	K962480	Coated Vicryl Rapide (Polyglactin 910) Braided, Synthetic Absorbable Suture, Undyed Summary page 2 …Suture which are also manufactured by Ethicon Inc. (Multiple 5 1O(k)’s e.g K022269, K974299, K962480). ~- 6 5100 Notificat…	ETHICON, Inc.	1996	2

What descends from it? (68)

See all 68

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051609	Quill Synthetic Absorbable Barbed Suture	Quill Medical, Inc.	2005	64
K033602	Insorb Absorbable Staple, Model SP-B20	Incisive Surgical, Inc.	2003	2
K131563	Subq IT! Bioabsorbable Skin Closure System	Opus Ksd, Inc.	2014	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 19, 2015	Class II	Z-1545-2015	Labeling False and Misleading	A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. The expiration date at the time of manufacturing was 2014-05.

No ancestor or descendant has a Class I recall.

What does this lineage say?

3 of the 5 ancestors have a recall of any class.
Of its descendants, K051609 (Quill Medical, Inc., 2005) has gone furthest, with 64 descendants of its own.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

Synthetic absorbable INSORB staples are intended for use in abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024117 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024117: Insorb Absorbable Staples, Model SP-B20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024117

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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