510(k) · Cleared
ClearedNeuroShield
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monarch Bioimplants GmbH · JXI Cuff, Nerve
Cleared on May 31, 2019 as substantially equivalent to K103081 (Biom'Up Sas, 2012) and 2 other predicates after a 114-day review. Its family tree reaches back 5 generations to 1985.
- Decided
- May 31, 2019
- Review
- 114 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K850785 (1985). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK850785 Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 1985
- 4 generations backK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- 3 generations backK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
- 2 generations backK103081 Covaortho-Nerve Resorbable Collagen MembraneBiom'Up Sas · 2012
- 1 generation backK152967 NerbridgeToyobo Co., Ltd. · 2016
- This deviceK190246 NeuroShieldMonarch Bioimplants GmbH · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K850785 | Fastube Nerve Regeneration Device | Research Medical, Inc. | 1985 | — |
| −4 | K012814 | Collagen Nerve Cuff | Collagen Matrix, Inc. | 2001 | — |
| −3 | K060952 | Collagen Nerve Wrap | Collagen Matrix, Inc. | 2006 | — |
| −2 | K103081 | Covaortho-Nerve Resorbable Collagen Membrane | Biom'Up Sas | 2012 | — |
| −1 | K152967 | Nerbridge | Toyobo Co., Ltd. | 2016 | — |
| 0 (this device) | K190246 | NeuroShield | Monarch Bioimplants GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2015 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K103081 | Covaortho-Nerve Resorbable Collagen MembraneSummary page 5…dicate Device: NeuroShieldTM is substantially equivalent in function and intended use to: 510(k) number Device name Device company K103081 CovaTMORTHO-NERVE Biom’Up Advance Biomaterials K143711 Reaxon® Plus… | 2012 |
| * | K143711 | Reaxon PlusSummary page 5…to: 510(k) number Device name Device company K103081 CovaTMORTHO-NERVE Biom’Up Advance Biomaterials K143711 Reaxon® Plus Medovent GmbH K152967 NerbridgeTM Toyo… | 2015 |
| * | K152967 | NerbridgeSummary page 5…mpany K103081 CovaTMORTHO-NERVE Biom’Up Advance Biomaterials K143711 Reaxon® Plus Medovent GmbH K152967 NerbridgeTM Toyoba Co., Ltd. The predicate devices are described in more detail below: •… | 2016 |
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?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 2 other devices also cite its predicate K103081.
How does its category compare?
All JXI devicesJXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · JXI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXI
99in 2025
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 1 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 11 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 3 | 309 | 0 | 7 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 3 | 117 | 0 | 8 |
| 2017 | 3 | 90 | 0 | 9 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 8 |
| 2023 | 3 | 122 | 0 | 15 |
| 2024 | 3 | 266 | 0 | 18 |
| 2025 | 4 | 99 | 0 | 18 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Under supervision of a healthcare professional
• NeuroShield[TM] is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure can be achieved by flexion of the extremity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190246: NeuroShield.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190246
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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