510(k) · Cleared
ClearedCollagen Nerve Wrap
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 Jul 14, 2006 as substantially equivalent to K012814 (Collagen Matrix, Inc., 2001) and 2 other predicates after a 99-day review. Its family tree reaches back 2 generations to 1985. 22 later devices descend from it.
- Decided
- Jul 14, 2006
- Review
- 99 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K850785 (1985). 5 ancestors in all. 22 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK850785 Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 1985
- 1 generation backK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- This deviceK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
- Descendant · cites it directly · 15 of its ownK080452 Collagen Tendon WrapCollagen Matrix, Inc. · 2008
- Descendant · 2 generations on · 14 of its ownK112423 Collagen Tendon SheetRotation Medical, Inc. · 2011
- Descendant · 3 generations on · 5 of its ownK201572 TAPESTRY Biointegrative ImplantEmbody, Inc. · 2020
- Descendant · 3 generations on · 5 of its ownK122048 Collagen Tendon Sheet-DRotation Medical, Inc. · 2013
- Descendant · 4 generations on · 4 of its ownK140300 Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc. · 2014
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K080452Collagen Tendon WrapCollagen Matrix, Inc. · 2008 · cites it directly15descendants
- K112423Collagen Tendon SheetRotation Medical, Inc. · 2011 · 2 generations on14descendants
- K201572TAPESTRY Biointegrative ImplantEmbody, Inc. · 2020 · 3 generations on5descendants
- K122048Collagen Tendon Sheet-DRotation Medical, Inc. · 2013 · 3 generations on5descendants
- K140300Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc. · 2014 · 4 generations on4descendants
View 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) | K060952 | Collagen Nerve Wrap | Collagen Matrix, Inc. | 2006 | — |
| +1 | K080452 | Collagen Tendon Wrap | Collagen Matrix, Inc. | 2008 | — |
| +2 | K112423 | Collagen Tendon Sheet | Rotation Medical, Inc. | 2011 | — |
| +3 | K201572 | TAPESTRY Biointegrative Implant | Embody, Inc. | 2020 | — |
| +3 | K122048 | Collagen Tendon Sheet-D | Rotation Medical, Inc. | 2013 | — |
| +4 | K140300 | Collagen Tendon Sheet-Ddi (CTS-Ddi) | Rotation Medical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K012814 | Collagen Nerve CuffSummary page 1…r: 882.5275 Device Class: Class II Product Code: X Predicate Device(s): Collagen Nerve Cuff, K012814 Collagen Matrix, Inc., Franklin Lakes, NJ NeuraWrapTm Ner… | 2001 |
| * | K041620 | Neura Wrap Nerve ProtectorSummary page 1…llagen Nerve Cuff, K012814 Collagen Matrix, Inc., Franklin Lakes, NJ NeuraWrapTm Nerve Protector, K041620 Integra LifeSciences Corporation, Plainsboro, NJ FASTUBETm… | 2004 |
| * | K850785 | Fastube Nerve Regeneration DeviceSummary page 1…tor, K041620 Integra LifeSciences Corporation, Plainsboro, NJ FASTUBETm Nerve Regeneration Device, K850785 Research Medical, Inc., Salt Lake City, UT Description of the Device Collagen Nerve Wrap is… | 1985 |
What descends from it? (22)
See all 224 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 21 years and passes through 2 companies; a new generation was cleared every 16.2 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K080452 (Collagen Matrix, Inc., 2008) has gone furthest, with 15 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.
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?
Collagen Nerve Wrap is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue 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/K060952 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060952: Collagen Nerve Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060952
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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