510(k) Report

510(k) · Cleared

Cleared

Macropore Surgi-Wrap Mast Bioresorbable Sheet

K031955510(k) TraditionalCleared Sep 22, 200389-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Macropore Biosurgery, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Sep 22, 2003 as substantially equivalent to K012025 (Macropore Biosurgery, Inc., 2001) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 2001. 76 later devices descend from it.

Decided
Sep 22, 2003
Review
89 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K002699 (2001). 2 ancestors in all. 76 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2007: 4 descendants cleared2004: 1 descendant cleared2009: 3 descendants cleared2013: 2 descendants cleared2010: 4 descendants cleared2006: 2 descendants cleared2005: 1 descendant cleared2021: 3 descendants cleared2008: 3 descendants cleared2014: 5 descendants cleared2012: 3 descendants cleared2015: 4 descendants cleared2011: 4 descendants cleared2017: 5 descendants cleared2018: 5 descendants cleared2019: 2 descendants cleared2016: 4 descendants cleared2023: 5 descendants cleared2022: 3 descendants cleared2020: 3 descendants cleared2026: 4 descendants cleared2025: 2 descendants cleared2024: 4 descendants clearedK002699 · Parietex Composite (Pco) Mesh · Medical Device Consultants, Inc. · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 9 descendants2 generations forward: 19 descendants3 generations forward: 15 descendants4 generations forward: 18 descendants5 generations forward: 8 descendants6 generations forward: 2 descendants7 generations forward: 4 descendants8 generations forward: 1 descendant K002699 · Parietex Composite (Pco) Mesh · Medical Device Consultants, Inc. · 20010+5
  1. Root · 1 generation backK002699 Parietex Composite (Pco) MeshMedical Device Consultants, Inc. · 2001
  2. This deviceK031955 Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc. · 2003
  3. Descendant · cites it directly · 36 of its ownK050332 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005
  4. Descendant · cites it directly · 22 of its ownK042811 Vivosorb Sheet, Model FS01Polyganics B.V., · 2004
  5. Descendant · cites it directly · 21 of its ownK062558 Mesosfol Surgical FilmBiomet Manufacturing Corp · 2007
  6. Descendant · cites it directly · 18 of its ownK090160 Suprathel Wound and Burn DressingPolymedics Innovations, GmbH · 2009
  7. Descendant · cites it directly · 17 of its ownK070894 Tephaflex Surgical MeshTepha, Inc. · 2007

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 22007: 42008: 32009: 32010: 42011: 42012: 32013: 22014: 52015: 42016: 42017: 52018: 52019: 22020: 32021: 32022: 32023: 52024: 42025: 22026: 4
2004high 5 (2014) · low 1 (2004)2026

Most influential descendants

Showing 5 of 76 · See all
  • K050332Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005 · cites it directly36descendants
  • K042811Vivosorb Sheet, Model FS01Polyganics B.V., · 2004 · cites it directly22descendants
  • K062558Mesosfol Surgical FilmBiomet Manufacturing Corp · 2007 · cites it directly21descendants
  • K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH · 2009 · cites it directly18descendants
  • K070894Tephaflex Surgical MeshTepha, Inc. · 2007 · cites it directly17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002699Parietex Composite (Pco) MeshMedical Device Consultants, Inc.2001—
0 (this device)K031955Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc.2003—
+1K050332Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc.2005—
+1K042811Vivosorb Sheet, Model FS01Polyganics B.V.,2004—
+1K062558Mesosfol Surgical FilmBiomet Manufacturing Corp2007—
+1K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH2009—
+1K070894Tephaflex Surgical MeshTepha, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200620
200740
200830
200930
201040
201140
201230
201320
201450
201540
201640
201750
201850
201920
202030
202130
202230
202350
202440
202520
202640
FIG. 1 — Lineage of K031955, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K012025Macropore Surgiwrap (TS)Macropore Biosurgery, Inc.2001—
*K002699Parietex Composite (Pco) MeshMedical Device Consultants, Inc.2001—

Also cleared against K012025: 4 other devices →

What descends from it? (76)

See all 76

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050332Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc.200536
K042811Vivosorb Sheet, Model FS01Polyganics B.V.,200422
K062558Mesosfol Surgical FilmBiomet Manufacturing Corp200721
K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH200918
K070894Tephaflex Surgical MeshTepha, Inc.200717
K062915Veritas Collagen MatrixSynovis Surgical Innovations200615
K130326Tephaflex Meltblown ConstructTepha, Inc.20130
K090637Cardio-WrapMast Biosurgery USA, Inc.20100
K071695Kensey Nash Macropore ShieldKensey Nash Corp.20070

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K050332 (Mast Biosurgery USA, Inc., 2005) has gone furthest, with 36 descendants of its own.
  • 4 other devices also cite its predicate K012025.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTL

6in 2025

2007: 202008: 232009: 152010: 182011: 152012: 122013: 82014: 112015: 122016: 32017: 62018: 122019: 42020: 52021: 22022: 62023: 42024: 22025: 62026 (partial year): 2
2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007: 92 days median2008: 114 days median2009: 97 days median2010: 132 days median2011: 90 days median2012: 213 days median2013: 90 days median2014: 70 days median2015: 121 days median2016: 186 days median2017: 132 days median2018: 105 days median2019: 99 days median2020: 138 days median2022: 195 days median2023: 29 days median2025: 30 days median
2007high 213 (2012) · low 29 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTL

1in 2020

2007: 22008: 12009: 12010: 122011: 82012: 22013: 12014: 32017: 12018: 12020: 1
2007high 12 (2010) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTL

3,487in 2025

2007: 1,7372008: 1,5692009: 1,9062010: 2,1752011: 3,6082012: 14,7002013: 26,5192014: 2,6832015: 2,5262016: 2,4172017: 3,9472018: 11,8932019: 21,7242020: 18,8192021: 16,2842022: 11,4392023: 8,0252024: 8,5652025: 3,487
2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007209221,737
20082311411,569
2009159711,906
201018132122,175
2011159083,608
201212213214,700
2013890126,519
2014117032,683
20151212102,526
2016318602,417
2017613213,947
201812105111,893
2019499021,724
20205138118,819
20212—016,284
20226195011,439
202342908,025
20242—08,565
202563003,487
20262—0—

What is it indicated for?

The MacroPore Surgi-Wrap MAST Bioresorbable Sheet is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists, 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. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.

Indications for use as stated in the FDA summary.

Also cleared against K012025

4 other devices cite the same predicate.

  • K113210Advantage-Strand/Advantage-Load Brachytherapy KitIsoaid, LLC · 2012
  • K071695Kensey Nash Macropore ShieldKensey Nash Corp. · 2007
  • K050332Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005
  • K024199Immix Thin Film, Models: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LPOsteobiologics, Inc. · 2003

More from Macropore Biosurgery, Inc.

17 FDA decisions under this applicant name. See the company

  • K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
  • K041105Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc. · 2004
  • K031785Macropore Cardio-Wrap (TS)Macropore Biosurgery, Inc. · 2003
  • K024169Macropore OS ReconstructionMacropore Biosurgery, Inc. · 2003
  • K023643Macropore Surgical Barrier FilmMacropore Biosurgery, Inc. · 2003

Recent decisions in FTL

The FTL category page

  • K260474Liora Monofilament ScaffoldTELA Bio, Inc. · 2026
  • K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026
  • K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production · 2025
  • K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025
  • K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc. · 2025

https://510kreport.com/device/K031955 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031955: Macropore 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/K031955

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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