510(k) · Cleared
ClearedCollagen Tendon Wrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Collagen Matrix, Inc. · FTM Mesh, Surgical
Cleared on May 15, 2008 as substantially equivalent to K053655 (Integra LifeSciences Corporation, 2006) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 1985. 15 later devices descend from it.
- Decided
- May 15, 2008
- Review
- 86 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K850785 (1985). 8 ancestors in all. 15 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK850785 Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 1985
- 2 generations backK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- 1 generation backK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
- This deviceK080452 Collagen Tendon WrapCollagen Matrix, Inc. · 2008
- Descendant · cites it directly · 14 of its ownK112423 Collagen Tendon SheetRotation Medical, Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK201572 TAPESTRY Biointegrative ImplantEmbody, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK122048 Collagen Tendon Sheet-DRotation Medical, Inc. · 2013
- Descendant · 3 generations on · 4 of its ownK140300 Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc. · 2014
- Descendant · 4 generations on · 3 of its ownK222501 Regeneten Bioinductive ImplantSmith and Nephew, Inc. · 2023
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K112423Collagen Tendon SheetRotation Medical, Inc. · 2011 · cites it directly14descendants
- K201572TAPESTRY Biointegrative ImplantEmbody, Inc. · 2020 · 2 generations on5descendants
- K122048Collagen Tendon Sheet-DRotation Medical, Inc. · 2013 · 2 generations on5descendants
- K140300Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc. · 2014 · 3 generations on4descendants
- K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc. · 2023 · 4 generations on3descendants
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 | K060952 | Collagen Nerve Wrap | Collagen Matrix, Inc. | 2006 | — |
| 0 (this device) | K080452 | Collagen Tendon Wrap | Collagen Matrix, Inc. | 2008 | — |
| +1 | K112423 | Collagen Tendon Sheet | Rotation Medical, Inc. | 2011 | — |
| +2 | K201572 | TAPESTRY Biointegrative Implant | Embody, Inc. | 2020 | — |
| +2 | K122048 | Collagen Tendon Sheet-D | Rotation Medical, Inc. | 2013 | — |
| +3 | K140300 | Collagen Tendon Sheet-Ddi (CTS-Ddi) | Rotation Medical, Inc. | 2014 | — |
| +4 | K222501 | Regeneten Bioinductive Implant | Smith and Nephew, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 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 FTM? 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 FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 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 |
|---|---|---|---|
| * | K053655 | Tendon Wrap Tendon ProtectorSummary page 1…878.3300 Device Class: Class 11 Product Code: FTM Predicate Device(s): Tendon WrapTm Tendon Protector, K053655 Integra LifeSciences Corporation, Plainsboro, NJ Collagen Ner… | 2006 |
| * | K060952 | Collagen Nerve WrapSummary page 1…rapTm Tendon Protector, K053655 Integra LifeSciences Corporation, Plainsboro, NJ Collagen Nerve Wrap, K060952, Collagen Matrix, Inc., Franklin Lakes, NJ Description of the Device Collagen Tendon Wrap is… | 2006 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112423 | Collagen Tendon Sheet | 2011 | 14 |
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 23 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K112423 (Rotation Medical, Inc., 2011) has gone furthest, with 14 descendants of its own.
- 6 other devices also cite its predicate K053655.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Collagen Tendon Wrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080452: Collagen Tendon Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080452
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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