510(k) · Cleared
ClearedCollagen Tendon Sheet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rotation Medical, Inc. · FTM Mesh, Surgical
Cleared on Dec 22, 2011 as substantially equivalent to K080452 (Collagen Matrix, Inc., 2008) after a 121-day review. Its family tree reaches back 4 generations to 1985. 14 later devices descend from it.
- Decided
- Dec 22, 2011
- Review
- 121 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K850785 (1985). 9 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK850785 Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 1985
- 3 generations backK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- 2 generations backK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
- 1 generation backK080452 Collagen Tendon WrapCollagen Matrix, Inc. · 2008
- This deviceK112423 Collagen Tendon SheetRotation Medical, Inc. · 2011
- Descendant · cites it directly · 5 of its ownK201572 TAPESTRY Biointegrative ImplantEmbody, Inc. · 2020
- Descendant · cites it directly · 5 of its ownK122048 Collagen Tendon Sheet-DRotation Medical, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK140300 Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc. · 2014
- Descendant · 3 generations on · 3 of its ownK222501 Regeneten Bioinductive ImplantSmith and Nephew, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK212306 Tapestry Biointegrative ImplantEmbody, Inc. · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K201572TAPESTRY Biointegrative ImplantEmbody, Inc. · 2020 · cites it directly5descendants
- K122048Collagen Tendon Sheet-DRotation Medical, Inc. · 2013 · cites it directly5descendants
- K140300Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc. · 2014 · 2 generations on4descendants
- K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc. · 2023 · 3 generations on3descendants
- K212306Tapestry Biointegrative ImplantEmbody, Inc. · 2021 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K850785 | Fastube Nerve Regeneration Device | Research Medical, Inc. | 1985 | — |
| −3 | K012814 | Collagen Nerve Cuff | Collagen Matrix, Inc. | 2001 | — |
| −2 | K060952 | Collagen Nerve Wrap | Collagen Matrix, Inc. | 2006 | — |
| −1 | K080452 | Collagen Tendon Wrap | Collagen Matrix, Inc. | 2008 | — |
| 0 (this device) | K112423 | Collagen Tendon Sheet | Rotation Medical, Inc. | 2011 | — |
| +1 | K201572 | TAPESTRY Biointegrative Implant | Embody, Inc. | 2020 | — |
| +1 | K122048 | Collagen Tendon Sheet-D | Rotation Medical, Inc. | 2013 | — |
| +2 | K140300 | Collagen Tendon Sheet-Ddi (CTS-Ddi) | Rotation Medical, Inc. | 2014 | — |
| +3 | K222501 | Regeneten Bioinductive Implant | Smith and Nephew, Inc. | 2023 | — |
| +2 | K212306 | Tapestry Biointegrative Implant | Embody, Inc. | 2021 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K080452 | Collagen Tendon WrapSummary page 1…FTM Legally marketed Devices to Which Substantial Equivalence is Claimed Predicate Device(s): Collagen Tendon Wrap, K0080452 Collagen Matrix, Inc., Oakland, NJ Description of the Device Collagen Tendon… | 2008 |
What descends from it? (14)
See all 143 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 26 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K201572 (Embody, Inc., 2020) has gone furthest, with 5 descendants of its own.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Sheet 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/K112423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112423: Collagen Tendon Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112423
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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