510(k) Report

510(k) · Cleared

Cleared

Immix Plastifilm

K032673510(k) SpecialCleared Oct 2, 200334-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

Osteobiologics, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Oct 2, 2003 after a 34-day review. The FDA summary names no predicate by number. 26 later devices descend from it.

Decided
Oct 2, 2003
Review
34 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
0

26 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2008: 1 descendant cleared2007: 1 descendant cleared2010: 1 descendant cleared2017: 4 descendants cleared2009: 1 descendant cleared2011: 1 descendant cleared2024: 4 descendants cleared2014: 1 descendant cleared2015: 1 descendant cleared2018: 1 descendant cleared2016: 1 descendant cleared2022: 1 descendant cleared2026: 2 descendants cleared2023: 3 descendants cleared2020: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK032673 Immix PlastifilmOsteobiologics, Inc. · 2003
  2. Descendant · cites it directly · 22 of its ownK042811 Vivosorb Sheet, Model FS01Polyganics B.V., · 2004
  3. Descendant · 2 generations on · 21 of its ownK062558 Mesosfol Surgical FilmBiomet Manufacturing Corp · 2007
  4. Descendant · 3 generations on · 18 of its ownK090160 Suprathel Wound and Burn DressingPolymedics Innovations, GmbH · 2009
  5. Descendant · 4 generations on · 10 of its ownK132397 Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014
  6. Descendant · 4 generations on · 5 of its ownK142879 BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2004: 12007: 12008: 12009: 12010: 12011: 12014: 12015: 12016: 12017: 42018: 12020: 12022: 12023: 32024: 42025: 12026: 2
2004high 4 (2017) · low 0 (2005)2026

Most influential descendants

Showing 5 of 26 · See all
  • K042811Vivosorb Sheet, Model FS01Polyganics B.V., · 2004 · cites it directly22descendants
  • K062558Mesosfol Surgical FilmBiomet Manufacturing Corp · 2007 · 2 generations on21descendants
  • K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH · 2009 · 3 generations on18descendants
  • K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014 · 4 generations on10descendants
  • K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K032673Immix PlastifilmOsteobiologics, Inc.2003—
+1K042811Vivosorb Sheet, Model FS01Polyganics B.V.,2004—
+2K062558Mesosfol Surgical FilmBiomet Manufacturing Corp2007—
+3K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH2009—
+4K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc.2014—
+4K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200710
200810
200910
201010
201110
201410
201510
201610
201740
201810
202010
202210
202330
202440
202510
202620
FIG. 1 — Lineage of K032673, 2003–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K042811Vivosorb Sheet, Model FS01Polyganics B.V.,200422
K082079Regen Collagen Scaffold (CS)Regen Biologics, Inc.20082

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?

  • Of its descendants, K042811 (Polyganics B.V.,, 2004) has gone furthest, with 22 descendants of its own.

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 IMMIXTMPlastiFilm is to be used wherever temporary wound support is required, to reinforce soft tissue 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. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.

Indications for use as stated in the FDA summary.

More from Osteobiologics, Inc.

9 FDA decisions under this applicant name. See the company

  • K051656Oct (Osteochondral Transplant) Comprehensive SystemOsteobiologics, Inc. · 2005
  • K041382Polygraft BGS; Bone Graft SubstituteOsteobiologics, Inc. · 2005
  • K043172Trugraft BGS Syringe, Model 600-041Osteobiologics, Inc. · 2005
  • K040047Polygraft BGS; Bone Graft SubstituteOsteobiologics, Inc. · 20041 recall
  • K033707Polygraft TCP Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX…Osteobiologics, Inc. · 2004

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/K032673 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032673: Immix Plastifilm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032673

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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