510(k) · Cleared
ClearedFlexible Cooagen Nerve Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Collagen Matrix, Inc. · JXI Cuff, Nerve
Cleared on Apr 3, 2014 as substantially equivalent to K012814 (Collagen Matrix, Inc., 2001) after a 309-day review. Its family tree reaches back 2 generations to 1985. 2 later devices descend from it.
- Decided
- Apr 3, 2014
- Review
- 309 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K850785 (1985). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK850785 Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 1985
- 1 generation backK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- This deviceK131541 Flexible Cooagen Nerve CuffCollagen Matrix, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK170656 Reinforced Flexible Collagen Nerve CuffCollagen Matrix, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK152684 Nerve Capping DevicePolyganics Innovations BV · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850785 | Fastube Nerve Regeneration Device | Research Medical, Inc. | 1985 | — |
| −1 | K012814 | Collagen Nerve Cuff | Collagen Matrix, Inc. | 2001 | — |
| 0 (this device) | K131541 | Flexible Cooagen Nerve Cuff | Collagen Matrix, Inc. | 2014 | — |
| +1 | K170656 | Reinforced Flexible Collagen Nerve Cuff | Collagen Matrix, Inc. | 2017 | — |
| +1 | K152684 | Nerve Capping Device | Polyganics Innovations BV | 2016 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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? (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 | Decided |
|---|---|---|---|
| * | K012814 | Collagen Nerve CuffSummary page 1…3. Legally Marketed Devices to Which Substantial Equivalence is Claimed Predicate Device(s): Collagen Nerve Cuff K012814 SilasticS Nerve Cuff Pre-amendment Device 14. Descr… | 2001 |
| * | — | Silastic Nerve Cuff Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 29 years and passes through 2 companies; a new generation was cleared every 16.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K170656 (Collagen Matrix, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K012814.
How does its category compare?
All JXI devicesJXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Flexible Collagen Nerve Cuff is used for the management of peripheral nerve injuries in discontinuities where gap closure can be achieved by flexion of the extremity (e.g., to prevent ingrowth of scar tissue) or at the end of the nerve in the foot to reduce the formation of symptomatic or painflul neuroma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131541: Flexible Cooagen 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/K131541
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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