510(k) · Cleared
ClearedREGENETEN™ Bioinductive Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Inc., Endoscopy Div. · OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Cleared on Nov 26, 2024 as substantially equivalent to K222501 (Smith and Nephew, Inc., 2023) after an 84-day review. Its family tree reaches back 8 generations to 1985.
- Decided
- Nov 26, 2024
- Review
- 84 days
- Class
- Class II
- Product code
- OWY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K850785 (1985). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK850785 Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 1985
- 7 generations backK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- 6 generations backK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
- 5 generations backK080452 Collagen Tendon WrapCollagen Matrix, Inc. · 2008
- 4 generations backK112423 Collagen Tendon SheetRotation Medical, Inc. · 2011
- 3 generations backK122048 Collagen Tendon Sheet-DRotation Medical, Inc. · 2013
- 2 generations backK140300 Collagen Tendon Sheet-Ddi (CTS-Ddi)Rotation Medical, Inc. · 2014
- 1 generation backK222501 Regeneten Bioinductive ImplantSmith and Nephew, Inc. · 2023
- This deviceK242631 REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K850785 | Fastube Nerve Regeneration Device | Research Medical, Inc. | 1985 | — |
| −7 | K012814 | Collagen Nerve Cuff | Collagen Matrix, Inc. | 2001 | — |
| −6 | K060952 | Collagen Nerve Wrap | Collagen Matrix, Inc. | 2006 | — |
| −5 | K080452 | Collagen Tendon Wrap | Collagen Matrix, Inc. | 2008 | — |
| −4 | K112423 | Collagen Tendon Sheet | Rotation Medical, Inc. | 2011 | — |
| −3 | K122048 | Collagen Tendon Sheet-D | Rotation Medical, Inc. | 2013 | — |
| −2 | K140300 | Collagen Tendon Sheet-Ddi (CTS-Ddi) | Rotation Medical, Inc. | 2014 | — |
| −1 | K222501 | Regeneten Bioinductive Implant | Smith and Nephew, Inc. | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K222501 | Regeneten Bioinductive ImplantSummary page 5…Traditional 510(k) Device Class: Class II Device Predicate: REGENETEN™ Bioinductive Implant (K222501) Smith & Nephew Inc REGENETEN™ Bioinductive Implant Attachment 15: 510(k) Summary T… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 39 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K222501.
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. 2024, 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?
The REGENETEN Bioinductive* Implant is indicated for the management and protection of tendon or extra-articular ligament injuries in which there has been no substantial loss of tendon or ligament tissue.
* Bioinductivity has been demonstrated for tendon only.
The REGENETEN Bioinductive Implant Delivery System is indicated for the arthroscopic delivery of the REGENETEN Bioinductive Implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242631: REGENETEN™ Bioinductive Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242631
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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