510(k) · Cleared

Cleared

Zippere - Bioabsorbable/Non-Absorbable Polymer Sling & Surgical Mesh

K030631510(k) TraditionalCleared May 19, 200380-day reviewClass II21 CFR 878.3300

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

Prosurg, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on May 19, 2003 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided: May 19, 2003
Review: 80 days
Class: Class II
Product code: FTL
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK030631 Zippere - Bioabsorbable/Non-Absorbable Polymer Sling & Surgical MeshProsurg, Inc. · 2003
Descendant · cites it directly · 0 of its ownK070846 Minisling Adjustable Polymer Sling & Surgical Mesh with…Prosurg, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all

K070846Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring SystemProsurg, Inc. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K030631	Zippere - Bioabsorbable/Non-Absorbable Polymer Sling & Surgical Mesh	Prosurg, Inc.	2003	—
+1	K070846	Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System	Prosurg, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K030631, 2003–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FTL? 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 FTL device

#1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K070846	Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System	Prosurg, Inc.	2007	0

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?

Of its descendants, K070846 (Prosurg, Inc., 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTL

6in 2025

2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007high 213 (2012) · low 29 (2023)2026

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

Recalls per year · FTL

1in 2020

2007high 12 (2010) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTL

3,487in 2025

2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, 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	20	92	2	1,737
2008	23	114	1	1,569
2009	15	97	1	1,906
2010	18	132	12	2,175
2011	15	90	8	3,608
2012	12	213	2	14,700
2013	8	90	1	26,519
2014	11	70	3	2,683
2015	12	121	0	2,526
2016	3	186	0	2,417
2017	6	132	1	3,947
2018	12	105	1	11,893
2019	4	99	0	21,724
2020	5	138	1	18,819
2021	2	—	0	16,284
2022	6	195	0	11,439
2023	4	29	0	8,025
2024	2	—	0	8,565
2025	6	30	0	3,487
2026	2	—	0	—

What is it indicated for?

Zipperem - Bioabsorbable / Non-absorbable Polymer Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the urological, gynecological or gastroentrological anatomy. This includes, but not limited to, the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and secral colpuspension.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K030631 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030631: Zippere - Bioabsorbable/Non-Absorbable Polymer Sling & Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030631

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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