510(k) · Cleared

Cleared

Collagen Nerve Cuff

K012814510(k) TraditionalCleared Sep 21, 200130-day reviewClass II21 CFR 882.5275

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

Cleared on Sep 21, 2001 as substantially equivalent to K011168 (Integra Lifesciences Corp., 2001) and 2 other predicates after a 30-day review. Its family tree reaches back 1 generation to 1985. 37 later devices descend from it.

Decided: Sep 21, 2001
Review: 30 days
Class: Class II
Product code: JXI
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K850785 (1985). 3 ancestors in all. 37 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK850785 Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 1985
This deviceK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
Descendant · cites it directly · 22 of its ownK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
Descendant · 2 generations on · 15 of its ownK080452 Collagen Tendon WrapCollagen Matrix, Inc. · 2008
Descendant · 3 generations on · 14 of its ownK112423 Collagen Tendon SheetRotation Medical, Inc. · 2011
Descendant · cites it directly · 10 of its ownK031069 Surgisis Nerve CuffCook Biotech, Inc. · 2003
Descendant · 2 generations on · 6 of its ownK132660 Nerve CuffCook Biotech Incorporated · 2014

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2003high 5 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 37 · See all

K060952Collagen Nerve WrapCollagen Matrix, Inc. · 2006 · cites it directly22descendants
K080452Collagen Tendon WrapCollagen Matrix, Inc. · 2008 · 2 generations on15descendants
K112423Collagen Tendon SheetRotation Medical, Inc. · 2011 · 3 generations on14descendants
K031069Surgisis Nerve CuffCook Biotech, Inc. · 2003 · cites it directly10descendants
K132660Nerve CuffCook Biotech Incorporated · 2014 · 2 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K850785	Fastube Nerve Regeneration Device	Research Medical, Inc.	1985	—
0 (this device)	K012814	Collagen Nerve Cuff	Collagen Matrix, Inc.	2001	—
+1	K060952	Collagen Nerve Wrap	Collagen Matrix, Inc.	2006	—
+2	K080452	Collagen Tendon Wrap	Collagen Matrix, Inc.	2008	—
+3	K112423	Collagen Tendon Sheet	Rotation Medical, Inc.	2011	—
+1	K031069	Surgisis Nerve Cuff	Cook Biotech, Inc.	2003	—
+2	K132660	Nerve Cuff	Cook Biotech Incorporated	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2006	1	0
2008	1	0
2010	1	0
2011	1	0
2012	1	0
2013	2	0
2014	4	0
2016	3	0
2017	2	0
2019	1	0
2020	1	0
2021	1	0
2022	3	0
2023	5	0
2024	4	0
2025	5	0

FIG. 1 — Lineage of K012814, 1985–2025Source: 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 JXI? 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 JXI device

#1 K232029 VersaWrap Nerve Protectorscore 12.6 · 2 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? (3)

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
*	K011168	Neurogen Nerve Guide Summary page 1 …ommerce Street Franklin Lakes, NJ 07417 Shu-Tung Li, Ph.D. President & CEO Tel: (201) 405-1477 August 20, 2001 Collagen Nerve Cuff None NeuroGen™ Nerve Guide [510(k) #K011168] SaluMedica™ Nerve Cuff [510(k) #K002098] Fastube™ Nerve Cuff [510(k) #K850785] The Collagen Nerve Cuff is designed to be a flex…	Integra Lifesciences Corp.	2001	2
*	K002098	Salumedica Nerve Cuff Summary page 1 …Shu-Tung Li, Ph.D. President & CEO Tel: (201) 405-1477 August 20, 2001 Collagen Nerve Cuff None NeuroGen™ Nerve Guide [510(k) #K011168] SaluMedica™ Nerve Cuff [510(k) #K002098] Fastube™ Nerve Cuff [510(k) #K850785] The Collagen Nerve Cuff is designed to be a flexible, resorbable and semipermeable tubul…	Salumedica, LLC	2000	—
*	K850785	Fastube Nerve Regeneration Device Summary page 1 …: (201) 405-1477 August 20, 2001 Collagen Nerve Cuff None NeuroGen™ Nerve Guide [510(k) #K011168] SaluMedica™ Nerve Cuff [510(k) #K002098] Fastube™ Nerve Cuff [510(k) #K850785] The Collagen Nerve Cuff is designed to be a flexible, resorbable and semipermeable tubular membrane matrix to provide a protec…	Research Medical, Inc.	1985	—

Also cleared against K011168: 8 other devices →

What descends from it? (37)

See all 37

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

Number	Device	Applicant	Decided	Descendants
K060952	Collagen Nerve Wrap	Collagen Matrix, Inc.	2006	22
K031069	Surgisis Nerve Cuff	Cook Biotech, Inc.	2003	10
K131541	Flexible Cooagen Nerve Cuff	Collagen Matrix, Inc.	2014	2
K233322	Mochida Nerve Cuff	Mochida Pharmaceutical Co., Ltd.	2024	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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K060952 (Collagen Matrix, Inc., 2006) has gone furthest, with 22 descendants of its own.
8 other devices also cite its predicate K011168.

How does its category compare?

All JXI devices

JXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JXI

4in 2025

2007high 4 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXI

99in 2025

2007high 309 (2014) · low 90 (2017)2026

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

Recalls per year · JXI

No recall names JXI since 2007.

Adverse event reports per year · JXI

18in 2025

2007high 18 (2024) · low 0 (2007)2025

MAUDE reports naming product code JXI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	7
2009	0	—	7
2010	1	—	8
2011	1	—	11
2012	1	—	0
2013	0	—	7
2014	3	309	7
2015	1	—	5
2016	3	117	8
2017	3	90	9
2018	1	—	6
2019	1	—	10
2020	1	—	5
2021	0	—	3
2022	2	—	8
2023	3	122	15
2024	3	266	18
2025	4	99	18
2026	2	—	—

What is it indicated for?

Collagen Nerve Cuff is intended for use in repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012814 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012814: Collagen Nerve Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012814

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026