510(k) · Cleared
ClearedVersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alafair Biosciences · OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Cleared on Jul 18, 2025 as substantially equivalent to K240817 (Alafair Biosciences, Inc., 2024) after a 49-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Jul 18, 2025
- Review
- 49 days
- Class
- Class II
- Product code
- OWW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K000019 (2000). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK000019 Single Size Tendon SpacerMedist International · 2000
- 6 generations backK053655 Tendon Wrap Tendon ProtectorIntegra LifeSciences Corporation · 2006
- 5 generations backK160364 VersaWrap Tendon ProtectorAlafair Biosciences, Inc. · 2016
- 4 generations backK200311 VersaWrap Tendon ProtectorAlafair Biosciences, Inc. · 2020
- 3 generations backK203600 VersaWrapAlafair Biosciences, Inc. · 2021
- 2 generations backK213163 VersaWrapAlafair Biosciences, Inc. · 2021
- 1 generation backK240817 VersaWrapAlafair Biosciences, Inc. · 2024
- This deviceK251655 VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector…Alafair Biosciences · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000019 | Single Size Tendon Spacer | Medist International | 2000 | — |
| −6 | K053655 | Tendon Wrap Tendon Protector | Integra LifeSciences Corporation | 2006 | — |
| −5 | K160364 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | 2016 | — |
| −4 | K200311 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | 2020 | — |
| −3 | K203600 | VersaWrap | Alafair Biosciences, Inc. | 2021 | — |
| −2 | K213163 | VersaWrap | Alafair Biosciences, Inc. | 2021 | — |
| −1 | K240817 | VersaWrap | Alafair Biosciences, Inc. | 2024 | — |
| 0 (this device) | K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) | Alafair Biosciences | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 OWW? 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 OWW device
- #1 K241906 BioBrace® Reinforced Implantscore 17.1 · 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 |
|---|---|---|---|
| * | K240817 | VersaWrapSummary page 5…r Common Name Surgical Mesh Classification number 21 CFR 878.3300 Product Code OWW Legally Marketed Predicate Device VersaWrap Tendon Protector (K240817) Device Description Summary VersaCoat Tendon Protector is an absorbable implant (device) designed to function as a gelatinous int… | 2024 |
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 25 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All OWW devicesOWW Mesh, Surgical, Absorbable, 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 · OWW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWW
81in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWW
No recall names OWW since 2007.
Adverse event reports per year · OWW
2in 2025
MAUDE reports naming product code OWW, 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 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 3 | 81 | 0 | 0 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VersaCoat Tendon Protector is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used to manage and protect surrounding tissues such as ligament and skeletal muscle. In these procedures, the device may encounter implanted structures such as anchors, grafts, staples, or sutures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251655 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251655: VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251655
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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