510(k) · Cleared
ClearedRegeneten Bioinductive Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith and Nephew, Inc. · OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Cleared on May 11, 2023 as substantially equivalent to K140300 (Rotation Medical, Inc., 2014) after a 266-day review. Its family tree reaches back 7 generations to 1985. 3 later devices descend from it.
- Decided
- May 11, 2023
- Review
- 266 days
- Class
- Class II
- Product code
- OWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K850785 (1985). 12 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK850785 Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 1985
- 6 generations backK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- 5 generations backK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
- 4 generations backK080452 Collagen Tendon WrapCollagen Matrix, Inc. · 2008
- 3 generations backK112423 Collagen Tendon SheetRotation Medical, Inc. · 2011
- 2 generations backK122048 Collagen Tendon Sheet-DRotation Medical, Inc. · 2013
- 1 generation backK140300 Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc. · 2014
- This deviceK222501 Regeneten Bioinductive ImplantSmith and Nephew, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK242187 BioBrace®Conmed Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK252946 BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation · 2025
- Descendant · cites it directly · 0 of its ownK242631 REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K850785 | Fastube Nerve Regeneration Device | Research Medical, Inc. | 1985 | — |
| −6 | K012814 | Collagen Nerve Cuff | Collagen Matrix, Inc. | 2001 | — |
| −5 | K060952 | Collagen Nerve Wrap | Collagen Matrix, Inc. | 2006 | — |
| −4 | K080452 | Collagen Tendon Wrap | Collagen Matrix, Inc. | 2008 | — |
| −3 | K112423 | Collagen Tendon Sheet | Rotation Medical, Inc. | 2011 | — |
| −2 | K122048 | Collagen Tendon Sheet-D | Rotation Medical, Inc. | 2013 | — |
| −1 | K140300 | Collagen Tendon Sheet-Ddi (CTS-Ddi) | Rotation Medical, Inc. | 2014 | — |
| 0 (this device) | K222501 | Regeneten Bioinductive Implant | Smith and Nephew, Inc. | 2023 | — |
| +1 | K242187 | BioBrace® | Conmed Corporation | 2024 | — |
| +2 | K252946 | BioBrace® Extra-Articular Ligament Augmentation Kit | Conmed Corporation | 2025 | — |
| +1 | 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 |
|---|---|---|
| 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 K251690 Arthrex SpeedFLEX™ Implantscore 13.1 · 11 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 |
|---|---|---|---|
| * | K140300 | Collagen Tendon Sheet-Ddi (CTS-Ddi)Summary page 4…l 510(k) Device Class: Class II Device Predicate: Rotation Medical Collagen Tendon Sheet (K140300) 1 of 4 Device Description: Regeneten Bioinductive Implant is… | 2014 |
What descends from it? (3)
2 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 38 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K242187 (Conmed Corporation, 2024) has gone furthest, with 1 descendant 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. 2023, 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?
Regeneten Bioinductive Implant is indicated for the management and protection of tendon injuries in which there has been
no substantial loss of tendon tissue.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222501 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222501: Regeneten Bioinductive Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222501
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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