510(k) · Cleared

Cleared

Rebound HRD

K063671510(k) TraditionalCleared Aug 16, 2007248-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

Minnesota Medical Development, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Aug 16, 2007 as substantially equivalent to K060520 (Proxy Biomedical, Ltd., 2006) and 1 other predicate after a 248-day review. Its family tree reaches back 1 generation to 1996. 10 later devices descend from it.

Decided: Aug 16, 2007
Review: 248 days
Class: Class II
Product code: FTL
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K963141 (1996). 2 ancestors in all. 10 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK963141 Kugel Hernia PatchDouglas Bueschel · 1996
This deviceK063671 Rebound HRDMinnesota Medical Development, Inc. · 2007
Descendant · cites it directly · 7 of its ownK092726 Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010
Descendant · 2 generations on · 6 of its ownK102766 Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · Recalled
Descendant · 3 generations on · 5 of its ownK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
Descendant · 3 generations on · 4 of its ownK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled
Descendant · cites it directly · 4 of its ownK080393 Modification to Rebound HRDMinnesota Medical Development, Inc. · 2008

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2008high 2 (2010) · low 0 (2014)2026

Most influential descendants

Showing 5 of 10 · See all

K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010 · cites it directly7descendants
K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · 2 generations on6descendants
K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011 · 3 generations on5descendants
K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc. · 2012 · 3 generations on4descendants
K080393Modification to Rebound HRDMinnesota Medical Development, Inc. · 2008 · cites it directly4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K963141	Kugel Hernia Patch	Douglas Bueschel	1996	—
0 (this device)	K063671	Rebound HRD	Minnesota Medical Development, Inc.	2007	—
+1	K092726	Mesh GPS - Large, Small, SM, SM Small	Surgical Structures, Ltd.	2010	—
+2	K102766	Composix L/P Mesh with Echo PS Positioning System	C.R. Bard, Inc.	2010	2
+3	K110820	Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System	C.R. Bard, Inc.	2011	—
+3	K122436	Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with…	C.R. Bard, Inc.	2012	15
+1	K080393	Modification to Rebound HRD	Minnesota Medical Development, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2010	2	0
2011	1	0
2012	1	0
2013	1	0
2015	1	0
2017	1	0
2018	1	0

FIG. 1 — Lineage of K063671, 1996–2018Source: 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 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K060520	Vitamesh Macroporous PP Surgical Mesh Summary page 1 …SSIFICATION NAME: surgical mesh PRO CODE: FTL SUBSTANTIALLY EQUIVALENT TO: VITAMESHITm MacroPorous PP Surgical Mesh K060520 and K963141 Kugel Hernia Patch DESCRIPTION of the DEVICE: The Rebound HRDTM (Hernia Repair Device) is a self-expanding Nitinol f…	Proxy Biomedical, Ltd.	2006	—
*	K963141	Kugel Hernia Patch Summary page 1 …NAME: surgical mesh PRO CODE: FTL SUBSTANTIALLY EQUIVALENT TO: VITAMESHITm MacroPorous PP Surgical Mesh K060520 and K963141 Kugel Hernia Patch DESCRIPTION of the DEVICE: The Rebound HRDTM (Hernia Repair Device) is a self-expanding Nitinol framed/surgic…	Douglas Bueschel	1996	—

Also cleared against K060520: 2 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K092726	Mesh GPS - Large, Small, SM, SM Small	Surgical Structures, Ltd.	2010	7
K080393	Modification to Rebound HRD	Minnesota Medical Development, Inc.	2008	4
K083467	Rebound HRDV	Minnesota Medical Development, Inc.	2009	3

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?

None of the 2 ancestors has a recall.
Of its descendants, K092726 (Surgical Structures, Ltd., 2010) has gone furthest, with 7 descendants of its own.
2 other devices also cite its predicate K060520.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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?

REBOUND HRDTM is intended to assist in the repair and/or reinforcement of hernia or other soft tissue defects where weakness exists and where the support of a nonabsorbable material is preferred.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063671 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063671: Rebound HRD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063671

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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