510(k) · Cleared
Recalled · Class II · 2014Surgi-Wrap Mast Bioresorbable Sheet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mast Biosurgery USA, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Sep 21, 2006 as substantially equivalent to K053655 (Integra LifeSciences Corporation, 2006) and 1 other predicate after a 114-day review. Its family tree reaches back 3 generations to 2001. 13 later devices descend from it. It has been recalled once.
- Decided
- Sep 21, 2006
- Review
- 114 days
- Class
- Class II
- Product code
- FTL
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002699 (2001). 9 ancestors in all, the oldest K000019 (2000). 13 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK002699 Parietex Composite (Pco) MeshMedical Device Consultants, Inc. · 2001
- 2 generations backK031955 Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc. · 2003
- 1 generation backK050332 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005
- This deviceK061473 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2006
- Descendant · cites it directly · 12 of its ownK063648 Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007
- Descendant · cites it directly · 10 of its ownK072190 Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008
- Descendant · 2 generations on · 9 of its ownK083823 Securian Tissue Reinforcement MatrixXylos Corporation · 2009
- Descendant · 3 generations on · 5 of its ownK111584 Xylos Macro-Porous Surgical MeshXylos Corporation · 2011
- Descendant · 4 generations on · 4 of its ownK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007 · cites it directly12descendants
- K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008 · cites it directly10descendants
- K083823Securian Tissue Reinforcement MatrixXylos Corporation · 2009 · 2 generations on9descendants
- K111584Xylos Macro-Porous Surgical MeshXylos Corporation · 2011 · 3 generations on5descendants
- K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002699 | Parietex Composite (Pco) Mesh | Medical Device Consultants, Inc. | 2001 | — |
| −2 | K031955 | Macropore Surgi-Wrap Mast Bioresorbable Sheet | Macropore Biosurgery, Inc. | 2003 | — |
| −1 | K050332 | Surgi-Wrap Mast Bioresorbable Sheet | Mast Biosurgery USA, Inc. | 2005 | — |
| 0 (this device) | K061473 | Surgi-Wrap Mast Bioresorbable Sheet | Mast Biosurgery USA, Inc. | 2006 | — |
| +1 | K063648 | Surgi-Wrap Mast Tendon Sheet | Mast Biosurgery USA, Inc. | 2007 | — |
| +1 | K072190 | Ortho-Wrap Bioresorbable Sheet | Mast Biosurgery | 2008 | — |
| +2 | K083823 | Securian Tissue Reinforcement Matrix | Xylos Corporation | 2009 | — |
| +3 | K111584 | Xylos Macro-Porous Surgical Mesh | Xylos Corporation | 2011 | — |
| +4 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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 3…nciples with the following predicate devices which have been determined by FDA to be substantially equivalent to pre-amendment devices: Integra LifeSciences Tendon Wrap (K053655) and MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet (K050332); Class II medical devices that were cleared for marketing in t… | 2006 |
| * | K050332 | Surgi-Wrap Mast Bioresorbable SheetSummary page 3…mined by FDA to be substantially equivalent to pre-amendment devices: Integra LifeSciences Tendon Wrap (K053655) and MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet (K050332); Class II medical devices that were cleared for marketing in the United States under K053655 and K050332 respectively. Indicat… | 2005 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 26, 2014 | Class II | Z-1076-2015 | Labeling Change Control | The expiration date of the bar code on the envelope label did not match the expiration date next to the hourglass. The printed expiration date was August of 2017, while the bar code date read as July 31, 2017. The correct expiration date… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K063648 (Mast Biosurgery USA, Inc., 2007) has gone furthest, with 12 descendants of its own.
- 6 other devices also cite its predicate K053655.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Surgi-Wrap MAST Bioresorbable Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The resorbable Protective Film minimizes tissue attachment to the device in case of direct contact with the tissues.
The device is indicated for open and laparoscopic / endoscopic procedures. Laparoscopic / endoscopic procedures are limited to sizes from 0.02mm - 0.2mm in thickness.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061473 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061473: Surgi-Wrap Mast Bioresorbable Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061473
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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