510(k) · Cleared
ClearedCollagen Tendon Sheet-Ddi (CTS-Ddi)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rotation Medical, Inc. · OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Cleared on Mar 26, 2014 as substantially equivalent to K122048 (Rotation Medical, Inc., 2013) after a 48-day review. Its family tree reaches back 6 generations to 1985. 4 later devices descend from it.
- Decided
- Mar 26, 2014
- Review
- 48 days
- Class
- Class II
- Product code
- OWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K850785 (1985). 11 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK850785 Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 1985
- 5 generations backK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- 4 generations backK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
- 3 generations backK080452 Collagen Tendon WrapCollagen Matrix, Inc. · 2008
- 2 generations backK112423 Collagen Tendon SheetRotation Medical, Inc. · 2011
- 1 generation backK122048 Collagen Tendon Sheet-DRotation Medical, Inc. · 2013
- This deviceK140300 Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK222501 Regeneten Bioinductive ImplantSmith and Nephew, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK242187 BioBrace®Conmed Corporation · 2024
- Descendant · 3 generations on · 0 of its ownK252946 BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK242631 REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div. · 2024
Most influential descendants
Showing 4 of 4 · See all- K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc. · 2023 · cites it directly3descendants
- K242187BioBrace®Conmed Corporation · 2024 · 2 generations on1descendant
- K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 2025 · 3 generations on0descendants
- K242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K850785 | Fastube Nerve Regeneration Device | Research Medical, Inc. | 1985 | — |
| −5 | K012814 | Collagen Nerve Cuff | Collagen Matrix, Inc. | 2001 | — |
| −4 | K060952 | Collagen Nerve Wrap | Collagen Matrix, Inc. | 2006 | — |
| −3 | K080452 | Collagen Tendon Wrap | Collagen Matrix, Inc. | 2008 | — |
| −2 | K112423 | Collagen Tendon Sheet | Rotation Medical, Inc. | 2011 | — |
| −1 | K122048 | Collagen Tendon Sheet-D | Rotation Medical, Inc. | 2013 | — |
| 0 (this device) | K140300 | Collagen Tendon Sheet-Ddi (CTS-Ddi) | Rotation Medical, Inc. | 2014 | — |
| +1 | K222501 | Regeneten Bioinductive Implant | Smith and Nephew, Inc. | 2023 | — |
| +2 | K242187 | BioBrace® | Conmed Corporation | 2024 | — |
| +3 | K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | 2025 | — |
| +2 | K242631 | REGENETEN™ Bioinductive Implant | Smith & Nephew Inc., Endoscopy Div. | 2024 | — |
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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 OWY? 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 OWY device
- #1 K222501 Regeneten Bioinductive Implantscore 13.1 · 7 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 |
|---|---|---|---|
| * | K122048 | Collagen Tendon Sheet-DSummary page 1…y Classification Code ORG Legally Marketed Devices to Which Substantial Equivalence is Claimed Predicate Device(s): Collagen Tendon Sheet-D, K1 22048 Rotation Medical, Inc. Description of the Device Collagen Tendon Sheet-ODI is a resorb… | 2013 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222501 | Regeneten Bioinductive Implant | 2023 | 3 |
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 3 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K222501 (Smith and Nephew, Inc., 2023) has gone furthest, with 3 descendants of its own.
How does its category compare?
All OWY devicesOWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OWY
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWY
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWY
No recall names OWY since 2007.
Adverse event reports per year · OWY
28in 2025
MAUDE reports naming product code OWY, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 1 | — | 0 | 14 |
| 2021 | 1 | — | 0 | 25 |
| 2022 | 1 | — | 0 | 15 |
| 2023 | 1 | — | 0 | 35 |
| 2024 | 1 | — | 0 | 24 |
| 2025 | 4 | 131 | 0 | 28 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Collagen Tendon Sheet-DIl 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/K140300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140300: Collagen Tendon Sheet-Ddi (CTS-Ddi).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140300
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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