510(k) · Cleared
ClearedTendon Protect (50242)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kerecis Limited · OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Cleared on Jun 4, 2025 as substantially equivalent to K053655 (Integra LifeSciences Corporation, 2006) and 1 other predicate after a 173-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Jun 4, 2025
- Review
- 173 days
- Class
- Class II
- Product code
- OWY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K921895 (1992). 33 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 8 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 6 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 5 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 4 generations backK050337 Sis Fistula PlugCook Biotech, Inc. · 2005
- 3 generations backK161221 Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal…Cook Biotech Incorporated · 2016
- 2 generations backK191696 Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign…Cook Biotech Incorporated · 2019
- 1 generation backK202430 Kerecis ReconstructKerecis Limited · 2021
- This deviceK243843 Tendon Protect (50242)Kerecis Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −7 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −6 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −5 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −4 | K050337 | Sis Fistula Plug | Cook Biotech, Inc. | 2005 | — |
| −3 | K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug | Cook Biotech Incorporated | 2016 | — |
| −2 | K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery… | Cook Biotech Incorporated | 2019 | — |
| −1 | K202430 | Kerecis Reconstruct | Kerecis Limited | 2021 | — |
| 0 (this device) | K243843 | Tendon Protect (50242) | Kerecis Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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? (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 5…n Number: 21 CFR 878.3300 Primary Predicate Device Company Name: Integra Lifesciences Corporation Device Name (Proprietary): Tendon Wrap Tendon Protector Device 510(k): K053655 Additional Predicate Device Company Name: Kerecis Limited Device Name (Proprietary): Kerecis® Reconstruct™ Device 510(k): K20243… | 2006 |
| * | K202430 | Kerecis ReconstructSummary page 5…n Wrap Tendon Protector Device 510(k): K053655 Additional Predicate Device Company Name: Kerecis Limited Device Name (Proprietary): Kerecis® Reconstruct™ Device 510(k): K202430 Reference Device Company Name: Kerecis Limited Device Name (Proprietary): MariGen Wound Dressing Device 510(k): K132343… | 2021 |
| † | K132343 | Marigen Wound Dressing | 2013 |
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 33 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 33 ancestors has a recall of any class.
- 6 other devices also cite its predicate K053655.
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. 2025, 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?
Kerecis Tendon Protect 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/K243843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243843: Tendon Protect (50242).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243843
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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