510(k) · Cleared

Cleared

Reaxon Plus

K143711510(k) TraditionalCleared Dec 2, 2015338-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 Dec 2, 2015 as substantially equivalent to K011168 (Integra Lifesciences Corp., 2001) after a 338-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Dec 2, 2015
Review: 338 days
Class: Class II
Product code: JXI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011168 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011168 Neurogen Nerve GuideIntegra Lifesciences Corp. · 2001 · Recalled
This deviceK143711 Reaxon PlusMedovent GmbH · 2015
Descendant · cites it directly · 0 of its ownK190246 NeuroShieldMonarch Bioimplants GmbH · 2019

Most influential descendants

Showing 1 of 1 · See all

K190246NeuroShieldMonarch Bioimplants GmbH · 2019 · cites it directly0descendants

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)	K143711	Reaxon Plus	Medovent GmbH	2015	—
+1	K190246	NeuroShield	Monarch Bioimplants GmbH	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K143711, 2001–2019Source: 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 …Integra LifeSciences Corporation 510(k) # K143711 K011168 Material Chitosan Collagen Indications For Use Repair of perip…	Integra Lifesciences Corp.	2001	2

Also cleared against K011168: 8 other devices →

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
K190246	NeuroShield	Monarch Bioimplants GmbH	2019	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?

Its one ancestor has a recall.
Of its descendants, K190246 (Monarch Bioimplants GmbH, 2019) has gone furthest, with 0 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. 2015, 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?

Reaxon® Plus is indicated for repair of peripheral nerve discontinuities up to 10 mm and where gap closure can be

achieved by flexion of the extremity.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K143711 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143711: Reaxon Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143711

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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