510(k) · Cleared

Cleared

NeuroSpan Bridge

K253363510(k) TraditionalCleared Jan 17, 2026109-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

Auxilium Biotechnologies, Inc. · JXI Cuff, Nerve

Cleared on Jan 17, 2026 as substantially equivalent to K011168 (Integra Lifesciences Corp., 2001) after a 109-day review. Its family tree reaches back 1 generation to 2001.

Decided: Jan 17, 2026
Review: 109 days
Class: Class II
Product code: JXI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011168 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK011168 Neurogen Nerve GuideIntegra Lifesciences Corp. · 2001 · Recalled
This deviceK253363 NeuroSpan BridgeAuxilium Biotechnologies, Inc. · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011168	Neurogen Nerve Guide	Integra Lifesciences Corp.	2001	2
0 (this device)	K253363	NeuroSpan Bridge	Auxilium Biotechnologies, Inc.	2026	—

FIG. 1 — Lineage of K253363, 2001–2026Source: 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 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

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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
*	K011168	Neurogen Nerve Guide Summary page 5 …, Nerve Classification name: Nerve cuff (21 CFR 882.5275) Regulatory class: II Product code: JXI Predicate Device Trade name: NeuraGen Nerve Guide (K011168) Regulation: 882.5275 - Nerve cuff Regulatory class: II Product code: JXI Device Description The NeuroSpan Bri…	Integra Lifesciences Corp.	2001	2

Also cleared against K011168: 8 other devices →

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.
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. 2026, this device’s year, is highlighted.

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?

The NeuroSpan Bridge is indicated for the repair of peripheral nerve discontinuities where a tensionless repair can be made (i.e., 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/K253363 · printed Nov 6, 2026

Cite this page

510(k) Report. “K253363: NeuroSpan Bridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253363

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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