(215 days)
No.
The device description indicates it is a physical surgical mesh designed for mechanical support and tissue scaffolding, with no components or functions related to data processing, algorithms, or artificial intelligence.
Yes
The device, DynaFlex, is indicated for the reinforcement of soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, acting as a mechanical support and scaffold for tissue ingrowth to provide temporary support during healing. These functions directly contribute to the healing process and restoration of tissue function, classifying it as a therapeutic device.
No
Explanation: The device description and intended use clearly state that DynaFlex is a surgical mesh for reinforcing soft tissue and providing mechanical support and a scaffold for tissue ingrowth. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly defines DynaFlex as a tangible, physical surgical mesh made of polydioxanone (PDO). It is described as being 3D-printed, absorbable, and provided in specific sizes, indicating a hardware component. The summary details physical tests like mechanical performance, degradation, and biocompatibility, all referring to a physical product, not software.
No.
This device is a surgical mesh primarily used for mechanical support and reinforcement of soft tissues, which is an in-vivo application, not an in-vitro diagnostic test.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
OXF, OWT, OWZ, OXC
Device Description
3DMatrix DynaFlex ("DynaFlex") is a single-use, fully absorbable, colorless, non-woven, 3D-printed, macroporous, polymeric surgical mesh made entirely of uncolored and undyed polydioxanone (PDO). DynaFlex is provided in three sizes, 6 cm x 5.5 cm, 6 cm x 14.5 cm, and 5 cm x 17 cm, that can be cut to the desired shape and size for each specific application at the time of use. DynaFlex is terminally sterilized by Ethylene Oxide validated to an SAL of 10-6 and intended to be used by prescription only in a healthcare facility or hospital.
DynaFlex is a medical device used for surgical repair or reinforcement of soft tissue. Once implanted, DynaFlex acts as a mechanical support to soft tissues and provides a scaffold for tissue ingrowth. It is designed to fully degrade over six to seven months. DynaFlex provides temporary mechanical support and stabilization during the healing process. DynaFlex mesh is not isotropic so the mechanical properties of DynaFlex mesh are direction dependent.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, including for hernia repair, muscle flap reinforcement, and general tissue reconstructions.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use in a healthcare facility or hospital.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing to demonstrate the product mechanical performance, mechanical and mass degradation, and bioabsorption were performed to determine substantial equivalence to the predicate. The nonclinical performance testing of DynaFlex demonstrated that the device is substantially equivalent to the predicate device in mechanical performance, mechanical and mass degradation kinetics, and in vivo bioabsorption.
Key performance characteristics of ball burst strength/force (ASTM D6797-15, Standard Test Method for Bursting Strength of Fabrics Constant-Rate-of-Extension (CRE) Ball Burst Test), suture pull-out strength (Internal Test Method), tear strength (ASTM D2261-13, Standard Test Method for Tearing Strength of Fabrics by the Tongue (Single Rip) Procedure (Constant-Rate-of-Extension Tensile Testing Machine), and tensile strength (ASTM D5035-11, Standard Test Method for Breaking Force and Elongation of Textile Fabrics (Strip Method) were substantially equivalent to the predicate device. The data supporting substantial equivalence and biocompatibility of DynaFlex included all endpoints, including hemolysis, that are required for long-term implant devices with tissue and bone, in accordance with ISO 10993-1.
All biocompatibility studies were conducted in compliance with Good Laboratory Practice (GLP) regulations (21 CFR Part 58) and in accordance with FDA Guidance for Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued September 4, 2020) to address all endpoints for a long-term contact device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
FDA 510(k) Clearance Letter - 3DMatrix DynaFlex
Page 1
May 21, 2025
PrintBio, Inc.
Janet Vargo
VP Regulatory Affairs
51-36 35th Street
Long Island City, New York 11101
Re: K243302
Trade/Device Name: 3DMatrix DynaFlex (DynaFlex)
Regulation Number: 21 CFR 878.3300
Regulation Name: Surgical Mesh
Regulatory Class: Class II
Product Code: OXF, OWT, OWZ, OXC
Dated: December 20, 2024
Received: December 20, 2024
Dear Janet Vargo:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Page 2
K243302 - Janet Vargo Page 2
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.
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K243302 - Janet Vargo Page 3
See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
TEK N. LAMICHHANE -S
Tek N. Lamichhane, Ph.D.
Assistant Director
DHT4B: Division of Infection Control
and Plastic and Reconstructive Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K243302
Device Name
3DMatrix DynaFlex (DynaFlex)
Indications for Use (Describe)
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
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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Office of Chief Information Officer
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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K243302 - Page 1 of 5
510(k) SUMMARY
1 SUBMITTER
PrintBio, Inc.
51-36 35th Street
Long Island City NY 11101
Regulatory Contact: Janet Vargo, PhD
Phone: 908-420-2707
email: jvargo@printbio.com
2 DATE PREPARED
May 15, 2025
3 DEVICE NAMES/CLASSIFICATION
Commercial Name: 3DMatrix DynaFlex (DynaFlex)
Common Name: Surgical Mesh
Regulation: 21CRF 878.3300
Classification Name: Mesh, Surgical, Absorbable, Plastic 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 SOFT MESH AND SOFT MESH PRESHAPED
510(k) Number: K052155
Reference Device: ULTRAPRO MESH
510(k) Number: K033337
5 DEVICE DESCRIPTION
3DMatrix DynaFlex ("DynaFlex") is a single-use, fully absorbable, colorless, non-woven, 3D-printed, macroporous, polymeric surgical mesh made entirely of uncolored and undyed polydioxanone (PDO). DynaFlex is provided in three sizes, 6 cm x 5.5 cm, 6 cm x 14.5 cm, and 5 cm x 17 cm, that can be cut to the desired shape and size for each specific application at the time of use. DynaFlex is terminally sterilized by Ethylene Oxide validated to an SAL of 10-6 and intended to be used by prescription only in a healthcare facility or hospital.
DynaFlex is a medical device used for surgical repair or reinforcement of soft tissue. Once
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K243302 - Page 2 of 5
implanted, DynaFlex acts as a mechanical support to soft tissues and provides a scaffold for tissue ingrowth. It is designed to fully degrade over six to seven months. DynaFlex provides temporary mechanical support and stabilization during the healing process. DynaFlex mesh is not isotropic so the mechanical properties of DynaFlex mesh are direction dependent.
6 INDICATIONS FOR USE
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
7 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
3DMatrix DynaFlex (DynaFlex) and the predicate 3DMatrix Surgical Mesh (3DMatrix) have the same indications and principle of operation. Both products have identical materials of composition, methods of manufacture, and packaging systems. Differences between DynaFlex and the predicate (density, pore size, and bi-directional mechanical properties) are characteristic of other FDA-cleared surgical meshes (reference devices K033337, K052155, and K163217) with very similar indications for use and do not raise new safety or effectiveness questions.
Mechanical and degradation testing completed on DynaFlex confirm equivalence to the predicate. Some of the biocompatibility testing, or sterilization validation were leveraged from the predicate device.
Table 1. Predicate and Reference Device Comparison Table – Technological Characteristics
| Subject Device – DynaFlex | Predicate – 3DMatrix | Reference Device - Gore® Bio-A® Tissue Reinforcement | Reference Device – Bard Large Pore Soft Mesh and Soft Mesh Preshaped | Reference Device – UltraPro | Comparison |
|---|---|---|---|---|---|
| 510(k) number K243302 | K232602 | K163217 | K052155 | K033337 | NA |
| Classification Class II, Surgical Mesh | Class II, Surgical Mesh | Class II, Surgical Mesh | Class II, Surgical Mesh | Class II, Surgical Mesh | Identical to predicate and reference devices |
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K243302 - Page 3 of 5
| Subject Device – DynaFlex | Predicate – 3DMatrix | Reference Device - Gore® Bio-A® Tissue Reinforcement | Reference Device – Bard Large Pore Soft Mesh and Soft Mesh Preshaped | Reference Device – UltraPro | Comparison |
|---|---|---|---|---|---|
| 510(k) number K243302 | K232602 | K163217 | K052155 | K033337 | NA |
| Indications for Use/Intended Use Indicated for: the reinforcement of soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. Examples of applications where 3DMatrix may be used include: - Suture line reinforcement including for hernia repair - Muscle flap reinforcement - General tissue reconstructions | Indicated for: the reinforcement of soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. Examples of applications where 3DMatrix may be used include: - Suture line reinforcement including for hernia repair - Muscle flap reinforcement - General tissue reconstructions | Intended for: use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery. Examples of applications where GORE® BIO-A® Tissue Reinforcement may be used include: -Hernia repair as suture line reinforcement | Bard® Large Pore Soft Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. Bard Large Pore Soft Mesh Pre-Shaped is indicated for the repair of inguinal hernia defects. | ULTRAPRO Mesh may be used for the repair of hernias and other abdominal fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result. | Identical to predicate and equivalent to reference devices |
| Material Polydioxanone (PDO) | Polydioxanone (PDO) | 67% polyglycolic acid (PGA): 33% trimethylene carbonate (TMC) | Polypropylene | 50% - absorbable poliglecaprone25 50% - polypropylene | Identical to predicate |
| Use Single Use | Single Use | Single Use | Single Use | Single Use | Identical to predicate and reference devices |
| Sterilization Mode & SAL Ethylene Oxide SAL 10-6 | Ethylene Oxide SAL 10-6 | Gamma SAL 10-6 | Ethylene Oxide SAL 10-6 | Ethylene Oxide SAL 10-6 | Identical to predicate and equivalent to reference devices K052155 and K033337 |
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K243302 - Page 4 of 5
| Subject Device – DynaFlex | Predicate – 3DMatrix | Reference Device - Gore® Bio-A® Tissue Reinforcement | Reference Device – Bard Large Pore Soft Mesh and Soft Mesh Preshaped | Reference Device – UltraPro | Comparison |
|---|---|---|---|---|---|
| 510(k) number K243302 | K232602 | K163217 | K052155 | K033337 | NA |
| Biodegradable Yes | Yes | Yes | No | Partial | Identical to predicate and equivalent to reference device K163217 |
| Primary Mechanism of Degradation Degradation via hydrolysis | Degradation via hydrolysis | Degradation via hydrolysis | None | Degradation of poliglecaprone25 via hydrolysis | Identical to predicate and equivalent to reference device K163217 |
| Biocompatible Yes | Yes | Yes | Yes | Yes | Identical or better than predicate and equivalent to reference devices |
| Packaging Double-layer Tyvek and polyethylene pouch, which is then sealed in a medical-grade foil pouch | Double-layer Tyvek and polyethylene pouch, which is then sealed in a medical-grade foil pouch | Double-layer Tyvek and polyethylene pouch, which is then sealed in a medical-grade foil pouch | Tyvek-Film Pouch, in a cardboard storage box | Folded cardboard, which is sealed in a medical-grade foil pouch | Identical to predicate and equivalent to reference device K163217 |
| Bioabsorption 6-7 months | 6-7 months | 6-7 months | None | 84 days - poliglecaprone25 component | Identical to predicate and equivalent to reference device K163217 |
| Storage Room Temperature | Room Temperature | Room Temperature | No special storage conditions | No special storage conditions | Identical to predicate and equivalent to reference device K163217 |
| Shape Rectangular | Rectangular | Rectangular, Square | Various Shapes | Various Shapes | Equivalent to predicate and reference devices |
| Pore Size (mm²) 7.5 ± 0.2 | 1.21 | Microporous | 6.29 | 3.4 | Equivalent to reference device K052155 |
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K243302 - Page 5 of 5
| Subject Device – DynaFlex | Predicate – 3DMatrix | Reference Device - Gore® Bio-A® Tissue Reinforcement | Reference Device – Bard Large Pore Soft Mesh and Soft Mesh Preshaped | Reference Device – UltraPro | Comparison |
|---|---|---|---|---|---|
| 510(k) number K243302 | K232602 | K163217 | K052155 | K033337 | NA |
| Density (g/m²) 289 | 392 | Not Available | 43.7 | 34 | Difference does not raise questions of safety or effectiveness |
| Bi-Directional Mechanics Yes | No | No | Yes | Yes | Equivalent to reference devices K052155 and K033337 |
8 NON-CLINICAL TESTS SUMMARY & CONCLUSIONS
Nonclinical testing to demonstrate the product mechanical performance, mechanical and mass degradation, and bioabsorption were performed to determine substantial equivalence to the predicate. The nonclinical performance testing of DynaFlex demonstrated that the device is substantially equivalent to the predicate device in mechanical performance, mechanical and mass degradation kinetics, and in vivo bioabsorption.
Key performance characteristics of ball burst strength/force (ASTM D6797-15, Standard Test Method for Bursting Strength of Fabrics Constant-Rate-of-Extension (CRE) Ball Burst Test), suture pull-out strength (Internal Test Method), tear strength (ASTM D2261-13, Standard Test Method for Tearing Strength of Fabrics by the Tongue (Single Rip) Procedure (Constant-Rate-of-Extension Tensile Testing Machine), and tensile strength (ASTM D5035-11, Standard Test Method for Breaking Force and Elongation of Textile Fabrics (Strip Method) were substantially equivalent to the predicate device. The data supporting substantial equivalence and biocompatibility of DynaFlex included all endpoints, including hemolysis, that are required for long-term implant devices with tissue and bone, in accordance with ISO 10993-1.
All biocompatibility studies were conducted in compliance with Good Laboratory Practice (GLP) regulations (21 CFR Part 58) and in accordance with FDA Guidance for Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued September 4, 2020) to address all endpoints for a long-term contact device.
9 CONCLUSIONS
Nonclinical testing results demonstrate that the device performs as well as the legally marketed predicate and reference devices identified in Section 4 of this summary.
The data support that the DynaFlex device is substantially equivalent to the predicate device in terms of intended/indications for use, design, materials, function, biocompatibility, and sterilization.