510(k) · Cleared
ClearedReinforced Flexible Collagen 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 Jun 1, 2017 as substantially equivalent to K131541 (Collagen Matrix, Inc., 2014) after a 90-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Jun 1, 2017
- Review
- 90 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K850785 (1985). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK850785 Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 1985
- 2 generations backK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- 1 generation backK131541 Flexible Cooagen Nerve CuffCollagen Matrix, Inc. · 2014
- This deviceK170656 Reinforced Flexible Collagen Nerve CuffCollagen Matrix, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K850785 | Fastube Nerve Regeneration Device | Research Medical, Inc. | 1985 | — |
| −2 | K012814 | Collagen Nerve Cuff | Collagen Matrix, Inc. | 2001 | — |
| −1 | K131541 | Flexible Cooagen Nerve Cuff | Collagen Matrix, Inc. | 2014 | — |
| 0 (this device) | K170656 | Reinforced Flexible Collagen Nerve Cuff | Collagen Matrix, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 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? (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 | Decided |
|---|---|---|---|
| * | K131541 | Flexible Cooagen Nerve CuffSummary page 4…egally Marketed Devices to Which Substantial Equivalence is Claimed Predicate Device(s): Flexible Collagen Nerve Cuff K131541 4. Description of the Device Reinforced Flexible Collagen Nerve Cuff is a resorbable, flexible type I collagen tubular m… | 2014 |
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 32 years and passes through 2 companies; a new generation was cleared every 12.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K131541.
How does its category compare?
All JXI devicesJXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Reinforced 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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170656 · printed Nov 3, 2026
Cite this page
510(k) Report. “K170656: Reinforced Flexible Collagen Nerve Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K170656
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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