510(k) · Cleared
ClearedVersaWrap Tendon Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alafair Biosciences, Inc. · OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Cleared on Jun 10, 2016 as substantially equivalent to K053655 (Integra LifeSciences Corporation, 2006) after a 122-day review. Its family tree reaches back 2 generations to 2000. 6 later devices descend from it.
- Decided
- Jun 10, 2016
- Review
- 122 days
- Class
- Class II
- Product code
- OWW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000019 (2000). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK000019 Single Size Tendon SpacerMedist International · 2000
- 1 generation backK053655 Tendon Wrap Tendon ProtectorIntegra LifeSciences Corporation · 2006
- This deviceK160364 VersaWrap Tendon ProtectorAlafair Biosciences, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK200311 VersaWrap Tendon ProtectorAlafair Biosciences, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK203600 VersaWrapAlafair Biosciences, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK213163 VersaWrapAlafair Biosciences, Inc. · 2021
- Descendant · 4 generations on · 1 of its ownK240817 VersaWrapAlafair Biosciences, Inc. · 2024
- Descendant · 5 generations on · 0 of its ownK251655 VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector…Alafair Biosciences · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K200311VersaWrap Tendon ProtectorAlafair Biosciences, Inc. · 2020 · cites it directly5descendants
- K203600VersaWrapAlafair Biosciences, Inc. · 2021 · 2 generations on4descendants
- K213163VersaWrapAlafair Biosciences, Inc. · 2021 · 3 generations on3descendants
- K240817VersaWrapAlafair Biosciences, Inc. · 2024 · 4 generations on1descendant
- K251655VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)Alafair Biosciences · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000019 | Single Size Tendon Spacer | Medist International | 2000 | — |
| −1 | K053655 | Tendon Wrap Tendon Protector | Integra LifeSciences Corporation | 2006 | — |
| 0 (this device) | K160364 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | 2016 | — |
| +1 | K200311 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | 2020 | — |
| +2 | K203600 | VersaWrap | Alafair Biosciences, Inc. | 2021 | — |
| +3 | K213163 | VersaWrap | Alafair Biosciences, Inc. | 2021 | — |
| +4 | K240817 | VersaWrap | Alafair Biosciences, Inc. | 2024 | — |
| +5 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K053655 | Tendon Wrap Tendon ProtectorSummary page 4…ction, function and intended use to Integra Lifesciences Corporation’s Tendon Wrap™ Tendon Protector (Tendon Wrap), K053655. Device Description: VersaWrap is an absorbable implant (device), designed to serve as an int… | 2006 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200311 | VersaWrap Tendon Protector | 2020 | 5 |
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 16 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K200311 (Alafair Biosciences, Inc., 2020) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K053655.
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. 2016, 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?
The VersaWrap Tendon Protector 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/K160364 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160364: VersaWrap Tendon Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160364
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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