510(k) · Cleared
ClearedVersaWrap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alafair Biosciences, Inc. · FTM Mesh, Surgical
Cleared on Mar 9, 2021 as substantially equivalent to K200311 (Alafair Biosciences, Inc., 2020) after a 90-day review. Its family tree reaches back 4 generations to 2000. 4 later devices descend from it.
- Decided
- Mar 9, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000019 (2000). 5 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK000019 Single Size Tendon SpacerMedist International · 2000
- 3 generations backK053655 Tendon Wrap Tendon ProtectorIntegra LifeSciences Corporation · 2006
- 2 generations backK160364 VersaWrap Tendon ProtectorAlafair Biosciences, Inc. · 2016
- 1 generation backK200311 VersaWrap Tendon ProtectorAlafair Biosciences, Inc. · 2020
- This deviceK203600 VersaWrapAlafair Biosciences, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK213163 VersaWrapAlafair Biosciences, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK240817 VersaWrapAlafair Biosciences, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK251655 VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector…Alafair Biosciences · 2025
- Descendant · 2 generations on · 0 of its ownK250109 TYBR Collagen GelTybr Health · 2025
Most influential descendants
Showing 4 of 4 · See all- K213163VersaWrapAlafair Biosciences, Inc. · 2021 · cites it directly3descendants
- K240817VersaWrapAlafair Biosciences, Inc. · 2024 · 2 generations on1descendant
- K251655VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)Alafair Biosciences · 2025 · 3 generations on0descendants
- K250109TYBR Collagen GelTybr Health · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000019 | Single Size Tendon Spacer | Medist International | 2000 | — |
| −3 | K053655 | Tendon Wrap Tendon Protector | Integra LifeSciences Corporation | 2006 | — |
| −2 | K160364 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | 2016 | — |
| −1 | K200311 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | 2020 | — |
| 0 (this device) | K203600 | VersaWrap | Alafair Biosciences, Inc. | 2021 | — |
| +1 | K213163 | VersaWrap | Alafair Biosciences, Inc. | 2021 | — |
| +2 | K240817 | VersaWrap | Alafair Biosciences, Inc. | 2024 | — |
| +3 | K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) | Alafair Biosciences | 2025 | — |
| +2 | K250109 | TYBR Collagen Gel | Tybr Health | 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 |
|---|---|---|
| 2021 | 1 | 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 FTM? 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 FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 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 |
|---|---|---|---|
| * | K200311 | VersaWrap Tendon ProtectorSummary page 4…n Protector Regulation Number 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Primary Predicate: K200311 VersaWrap Reference Device: K201631 VersaWrap VersaWrap® is an absorbable implant (device), designed… | 2020 |
| † | K201631 | VersaWrap Nerve Protector | 2020 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213163 | VersaWrap | 2021 | 3 |
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 21 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K213163 (Alafair Biosciences, Inc., 2021) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
VersaWrap 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 in the management and protection of surrounding tissues such as skeletal muscle and ligament.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203600: VersaWrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203600
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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