510(k) · Cleared
Cleared3DMatrix DynaFlex (DynaFlex)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Printbio, Inc. · OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Cleared on May 21, 2025 as substantially equivalent to K232602 (Printbio, Inc., 2024) after a 215-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- May 21, 2025
- Review
- 215 days
- Class
- Class II
- Product code
- OXF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K921895 (1992). 54 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations between
- 3 generations backK132025 Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical · 2013
- 2 generations backK163217 GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2017
- 1 generation backK232602 3DMatrix Surgical MeshPrintbio, Inc. · 2024
- This deviceK243302 3DMatrix DynaFlex (DynaFlex)Printbio, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 9 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 8 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 7 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 6 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 5 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 4 generations backK094061 Kensey Nash Ecm Surgical PatchKensey Nash Corporation · 2010
- 3 generations backK132025 Meso Bilayer Surgical MeshKensey Nash Corporation Dba Dsm Biomedical · 2013
- 2 generations backK163217 GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. · 2017
- 1 generation backK232602 3DMatrix Surgical MeshPrintbio, Inc. · 2024
- This deviceK243302 3DMatrix DynaFlex (DynaFlex)Printbio, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −9 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −8 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −7 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −6 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −5 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −4 | K094061 | Kensey Nash Ecm Surgical Patch | Kensey Nash Corporation | 2010 | — |
| −3 | K132025 | Meso Bilayer Surgical Mesh | Kensey Nash Corporation Dba Dsm Biomedical | 2013 | — |
| −2 | K163217 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2017 | — |
| −1 | K232602 | 3DMatrix Surgical Mesh | Printbio, Inc. | 2024 | — |
| 0 (this device) | K243302 | 3DMatrix DynaFlex (DynaFlex) | Printbio, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 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 OXF? 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 OXF device
- #1 K232602 3DMatrix Surgical Meshscore 12.8 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K232602 | 3DMatrix Surgical MeshSummary page 5…and Reconstructive Surgery Regulatory Class: II Product Codes: OXF, OWT, OWZ, OXC 4 PREDICATE DEVICES Predicate Device Name: 3DMatrix 510(k) Number: K232602 Reference Device Name: GORE® BIO-A® Tissue Reinforcement 510(k) Number: K163217 Reference Device: BARD LARGE PORE S… | 2024 |
| † | K163217 | GORE BIO-A Tissue Reinforcement | 2017 |
| † | K052155 | Bard Large Pore Soft Mesh and Soft Mesh Preshaped | 2005 |
| † | K033337 | Ultrapro Mesh | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 8 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 54 ancestors have a recall of any class.
How does its category compare?
All OXF devicesOXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OXF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXF
Too few OXF 510(k)s in any year since 2007 to give a median.
Recalls per year · OXF
No recall names OXF since 2007.
Adverse event reports per year · OXF
1in 2023
MAUDE reports naming product code OXF, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 14 |
| 2014 | 0 | — | 0 | 129 |
| 2015 | 0 | — | 0 | 107 |
| 2016 | 0 | — | 0 | 52 |
| 2017 | 2 | — | 0 | 25 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
3DMatrix DynaFlex (DynaFlex) is indicated for the reinforcement of soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. Examples of applications where DynaFlex may be used include
- Suture line reinforcement including for hernia repair
- Muscle flap reinforcement
- General tissue reconstructions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243302: 3DMatrix DynaFlex (DynaFlex).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243302
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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