510(k) · Cleared
ClearedSurgi-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 May 27, 2005 as substantially equivalent to K031955 (Macropore Biosurgery, Inc., 2003) and 3 other predicates after a 106-day review. Its family tree reaches back 2 generations to 2001. 36 later devices descend from it.
- Decided
- May 27, 2005
- Review
- 106 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K002699 (2001). 5 ancestors in all. 36 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK002699 Parietex Composite (Pco) MeshMedical Device Consultants, Inc. · 2001
- 1 generation backK031955 Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc. · 2003
- This deviceK050332 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005
- Descendant · cites it directly · 17 of its ownK070894 Tephaflex Surgical MeshTepha, Inc. · 2007
- Descendant · cites it directly · 13 of its ownK061473 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 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
- Descendant · 3 generations on · 9 of its ownK083823 Securian Tissue Reinforcement MatrixXylos Corporation · 2009
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K070894Tephaflex Surgical MeshTepha, Inc. · 2007 · cites it directly17descendants
- K061473Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2006 · cites it directly13descendants
- K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007 · 2 generations on12descendants
- K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008 · 2 generations on10descendants
- K083823Securian Tissue Reinforcement MatrixXylos Corporation · 2009 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002699 | Parietex Composite (Pco) Mesh | Medical Device Consultants, Inc. | 2001 | — |
| −1 | K031955 | Macropore Surgi-Wrap Mast Bioresorbable Sheet | Macropore Biosurgery, Inc. | 2003 | — |
| 0 (this device) | K050332 | Surgi-Wrap Mast Bioresorbable Sheet | Mast Biosurgery USA, Inc. | 2005 | — |
| +1 | K070894 | Tephaflex Surgical Mesh | Tepha, Inc. | 2007 | — |
| +1 | K061473 | Surgi-Wrap Mast Bioresorbable Sheet | Mast Biosurgery USA, Inc. | 2006 | 1 |
| +2 | K063648 | Surgi-Wrap Mast Tendon Sheet | Mast Biosurgery USA, Inc. | 2007 | — |
| +2 | K072190 | Ortho-Wrap Bioresorbable Sheet | Mast Biosurgery | 2008 | — |
| +3 | K083823 | Securian Tissue Reinforcement Matrix | Xylos Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K031955 | Macropore Surgi-Wrap Mast Bioresorbable SheetSummary page 3…Sheet, MacroPore SurgiWrap (TS), GFE Medizintechnik TiMESH, and the InjecTx Biosling; Class II medical devices that were cleared for marketing in the United States under K031955, K012025, K031225, and K010533 respectively. Indications For Use The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet shares… | 2003 |
| * | K012025 | Macropore Surgiwrap (TS)Summary page 3…croPore SurgiWrap (TS), GFE Medizintechnik TiMESH, and the InjecTx Biosling; Class II medical devices that were cleared for marketing in the United States under K031955, K012025, K031225, and K010533 respectively. Indications For Use The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet shares identica… | 2001 |
| * | K031225 | Timesh Also Known as Timesh-TC, Models 6000001 & 6000004Summary page 3…urgiWrap (TS), GFE Medizintechnik TiMESH, and the InjecTx Biosling; Class II medical devices that were cleared for marketing in the United States under K031955, K012025, K031225, and K010533 respectively. Indications For Use The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet shares identical indicat… | 2003 |
| * | K010533 | Biosling - Bioabsorbable Polymer Sling & Surgical MeshSummary page 3…, GFE Medizintechnik TiMESH, and the InjecTx Biosling; Class II medical devices that were cleared for marketing in the United States under K031955, K012025, K031225, and K010533 respectively. Indications For Use The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet shares identical indications for use… | 2001 |
What descends from it? (36)
See all 365 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)
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 4 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K070894 (Tepha, Inc., 2007) has gone furthest, with 17 descendants of its own.
- 8 other devices also cite its predicate K031955.
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 to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: pubourethral support and…
Read the full statement (127 words)
The Surgi-Wrap MAST Bioresorbable Sheet is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse, repair, reconstruction of the pelvic floor and sacral colposuspension. The resorbable Protective Film minimizes tissue attachment to the device in case of direct contact with the viscera. The device is indicated for open and laparoscopic procedures. Laparoscopic 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/K050332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050332: Surgi-Wrap Mast Bioresorbable Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050332
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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