510(k) · Cleared
ClearedTendon Wrap Tendon Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · FTM Mesh, Surgical
Cleared on Feb 3, 2006 as substantially equivalent to K041620 (Integra Lifesciences Corp., 2004) and 1 other predicate after a 35-day review. Its family tree reaches back 1 generation to 2000. 39 later devices descend from it.
- Decided
- Feb 3, 2006
- Review
- 35 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000019 (2000). 2 ancestors in all. 39 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK000019 Single Size Tendon SpacerMedist International · 2000
- This deviceK053655 Tendon Wrap Tendon ProtectorIntegra LifeSciences Corporation · 2006
- Descendant · cites it directly · 15 of its ownK080452 Collagen Tendon WrapCollagen Matrix, Inc. · 2008
- Descendant · 2 generations on · 14 of its ownK112423 Collagen Tendon SheetRotation Medical, Inc. · 2011
- Descendant · cites it directly · 13 of its ownK061473 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2006 · Recalled
- Descendant · cites it directly · 12 of its ownK063648 Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007
- Descendant · 2 generations on · 10 of its ownK072190 Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K080452Collagen Tendon WrapCollagen Matrix, Inc. · 2008 · cites it directly15descendants
- K112423Collagen Tendon SheetRotation Medical, Inc. · 2011 · 2 generations on14descendants
- K061473Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2006 · cites it directly13descendants
- K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007 · cites it directly12descendants
- K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000019 | Single Size Tendon Spacer | Medist International | 2000 | — |
| 0 (this device) | K053655 | Tendon Wrap Tendon Protector | Integra LifeSciences Corporation | 2006 | — |
| +1 | K080452 | Collagen Tendon Wrap | Collagen Matrix, Inc. | 2008 | — |
| +2 | K112423 | Collagen Tendon Sheet | Rotation Medical, Inc. | 2011 | — |
| +1 | K061473 | Surgi-Wrap Mast Bioresorbable Sheet | Mast Biosurgery USA, Inc. | 2006 | 1 |
| +1 | K063648 | Surgi-Wrap Mast Tendon Sheet | Mast Biosurgery USA, Inc. | 2007 | — |
| +2 | K072190 | Ortho-Wrap Bioresorbable Sheet | Mast Biosurgery | 2008 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 8 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K041620 | Neura Wrap Nerve ProtectorSummary page 1…ially equivalent in function and intended use to the following products which have been cleared to market under Premarket Notifications 510(k): NeuraWrap ® K041620 Nerve Protector and Medist International Tendon Spacer 510 K 000019. Device Description: Tendon Wrap is an absorbab… | 2004 |
| * | K000019 | Single Size Tendon SpacerSummary page 1…ucts which have been cleared to market under Premarket Notifications 510(k): NeuraWrap ® K041620 Nerve Protector and Medist International Tendon Spacer 510 K 000019. Device Description: Tendon Wrap is an absorbable implant (device) that provides a non-constricting, protective enc… | 2000 |
What descends from it? (39)
See all 397 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080452 | Collagen Tendon Wrap | 2008 | 15 |
| K061473 | Surgi-Wrap Mast Bioresorbable Sheet | 2006 | 13 |
| K063648 | Surgi-Wrap Mast Tendon Sheet | 2007 | 12 |
| K160364 | VersaWrap Tendon Protector | 2016 | 6 |
| K162570 | Miromatrix Biological Mesh TW | 2017 | 1 |
| K243843 | Tendon Protect (50242) | 2025 | 0 |
| K203496 | Nexo-Gide Bilayer Collagen Membrane | 2021 | 0 |
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?
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Tendon Wrap™ 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/K053655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053655: Tendon Wrap Tendon Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053655
Report an extraction error
Are you the manufacturer?
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