Who is the manufacturer of 3DMatrix Surgical Mesh?

Printbio, Inc. filed the 510(k) submission for 3DMatrix Surgical Mesh (K232602).

What is the FDA product code for 3DMatrix Surgical Mesh?

OXF. It is classified under 21 CFR 878.3300 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for 3DMatrix Surgical Mesh?

510(k) clearance (submission type: Traditional).

What are the predicate devices for 3DMatrix Surgical Mesh?

GORE® BIO-A® Tissue Reinforcement (K163217).

Who can help prepare an FDA 510(k) submission like 3DMatrix Surgical Mesh?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

3DMatrix Surgical Mesh

K232602 · Printbio, Inc. · OXF · May 23, 2024 · General, Plastic Surgery

Device Facts

Record ID	K232602
Device Name	3DMatrix Surgical Mesh
Applicant	Printbio, Inc.
Product Code	OXF · General, Plastic Surgery
Decision Date	May 23, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.3300
Device Class	Class 2
Attributes	Therapeutic

Intended Use

3DMatrix is 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

Device Story

3DMatrix Surgical Mesh is a single-use, fully absorbable, non-woven, 3D-printed, macroporous surgical mesh composed of polydioxanone (PDO). It is provided in two sizes and can be cut to size by the surgeon. Used in healthcare facilities, the device is implanted to provide temporary mechanical support and stabilization to soft tissues during the healing process, acting as a scaffold for tissue ingrowth. It degrades via hydrolysis over six to seven months. The device benefits patients by reinforcing weakened soft tissue during plastic and reconstructive procedures.

Clinical Evidence

Bench testing only. Studies included biocompatibility (ISO 10993-1), performance, packaging, sterilization, and shelf-life. Performance testing included ball burst strength (ASTM D6797-15), suture pull-out strength, tear strength (ASTM D2261-13), and tensile strength (ASTM D5035-11). Results demonstrate performance comparable to the predicate device.

Technological Characteristics

Material: Polydioxanone (PDO). Form: 3D-printed, non-woven, macroporous mesh. Dimensions: 60x55mm or 60x145mm; 0.6mm thickness; 392 g/m² density. Sterilization: Ethylene Oxide (SAL 10^-6). Degradation: Hydrolysis (6-7 months).

Indications for Use

Indicated for soft tissue reinforcement in patients undergoing plastic and reconstructive surgery, including hernia repair, muscle flap reinforcement, and general tissue reconstructions.

Regulatory Classification

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.

Predicate Devices

GORE® BIO-A® Tissue Reinforcement (K163217)

Reference Devices

Polydioxanone Surgical Scaffold™ (K181094)
Gore-Tex Soft Tissue Patch and Dualmesh (K963619)
PDS Flexible Plate (K092590)

Related Devices

K243302 — 3DMatrix DynaFlex (DynaFlex) · Printbio, Inc. · May 21, 2025
K181094 — Polydioxanone Surgical Scaffold · Lntegra Lifesciences · Aug 2, 2018
K161092 — GalaSHAPE 3D · Tepha, Inc. · Aug 23, 2016
K214070 — OviTex PRS (Long Term Resorbable) · Tela Bio · Mar 21, 2023
K161424 — Phasix Mesh · C.R. Bard, Inc. · Sep 29, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. May 23, 2024 PrintBio, Inc. Janet Vargo Official Correspondnet 51-36 35th Street Long Island City, New York 11101 Re: K232602 Trade/Device Name: 3DMatrix Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXF, OWT, OWZ, OXC Dated: April 22, 2024 Received: April 22, 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 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). {1}------------------------------------------------ 2 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 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-reportingcombination-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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, Digitally signed by Tek N. Tek N. Lamichhane -S Lamichhane -S Date: 2024.05.23 12:29:01 12:29:01 12:29:01 12:29:04:00' Tek Lamichhane 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232602 Device Name 3DMatrix Surgical Mesh ("3DMatrix") Indications for Use (Describe) 3DMatrix is 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 | Type of Use (Select one or both, as applicable) | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | <table><tr><td><div style="display:inline-block;"> <input checked="true" type="checkbox"/> </div> Research Use (Part 21 CFR 361.2 Subject to Review) </td><td><div style="display:inline-block;"> <input type="checkbox"/> </div> Over-The-Counter Use (21 CFR 361.2 Subject to Review) </td></tr></table> | <div style="display:inline-block;"> <input checked="true" type="checkbox"/> </div> Research Use (Part 21 CFR 361.2 Subject to Review) | <div style="display:inline-block;"> <input type="checkbox"/> </div> Over-The-Counter Use (21 CFR 361.2 Subject to Review) | | <div style="display:inline-block;"> <input checked="true" type="checkbox"/> </div> Research Use (Part 21 CFR 361.2 Subject to Review) | <div style="display:inline-block;"> <input type="checkbox"/> </div> Over-The-Counter Use (21 CFR 361.2 Subject to Review) | | > Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ # 510(k) SUMMARY-K232602 #### SUBMITTER 1 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 23, 2024 - 3 DEVICE NAMES/CLASSIFICATION Commercial Name: 3DMatrix Common Name: Surgical Mesh Regulation: 21CRF 878.3300 Regulatory Class: II Product Codes: OXF, OWT, OWZ, OXC #### 4 PREDICATE DEVICES Predicate Device Name: GORE® BIO-A® Tissue Reinforcement 510(k) Number: K163217 Reference Device: Polydioxanone Surgical Scaffold™ 510(k) Number: K181094 Reference Device: Gore-Tex Soft Tissue Patch and Dualmesh (510(k) Number: K963619 Reference Device: PDS Flexible Plate 510(k) Number: K092590 #### DEVICE DESCRIPTION ട് 3DMatrix Surgical Mesh (3DMatrix) is a single-use, fully absorbable, colorless, non-woven, 3Dprinted, macroporous, polymeric surgical mesh made entirely of uncolored and undyed polydioxanone (PDO). 3DMatrix is provided in two sizes, 60 mm x 55 mm and 60 mm x 145 mm that can be cut to the desired shape and size for each specific application at the time of use. 3DMatrix is terminally sterilized by Ethylene Oxide validated to an SAL of 10- and intended to be used by prescription only in a healthcare facility or hospital. 3DMatrix is a medical device used for surgical repair or reinforcement of soft tissue. Once implanted, 3DMatrix 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. 3DMatrix provides temporary mechanical support and stabilization during the healing process. {4}------------------------------------------------ #### 6 INDICATIONS FOR USE 3DMatrix is 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 ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 7 PREDICATE DEVICE The information provided in this premarket notification supports that the differences in mesh thickness, density, material (PDO vs. 67% polyglycolic acid [PGA] + 33% trimethylene carbonate [TMC]), sterilization method (ethylene oxide vs gamma radiation) between the subject and predicate mesh device raise no new issues of safety or effectiveness when used as intended. 3DMatrix does have similar density to the legally marketed reference device K963619; similar material, sterilization method, mesh thickness, and density as the legally marketed reference device K092590; and has similar material and sterilization method to legally marketed reference device K181094. | | Subject Device - 3DMatrix | Predicate- Gore® Bio-A® Tissue Reinforcement | Reference Device Polydioxano ne Surgical Scaffold™ | Reference Device - Gore® GORE-TEX® SOFT TISSUE PATCH | Reference Device - PDS Flexible Plate | Comparison | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | K232602 | K163217 | K181094 | K963619 | K092590 | NA | | Classification | Class II, Surgical Mesh | Class II, Surgical Mesh | Class II, Surgical Mesh | Class II, Surgical Mesh | Class II; ear, nose and throat synthetic polymer material | Equivalent to predicate and reference devices K181094 and K963619 | | 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 | 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 | Intended for: use in reinforcement of soft tissue where weakness exists. | Intended for: Used for the reconstruction of hernias and for the temporary bridging of fascial defects and soft tissue deficiencies | Indicated for: -Nasal soft- tissue and cartilage reconstruction | Equivalent to predicate | | Subject Device - 3DMatrix | Predicate- Gore® Bio-A® Tissue Reinforcement | Reference Device Polydioxanone Surgical Scaffold™ | Reference Device - Gore® GORE-TEX® SOFT TISSUE PATCH | Reference Device - PDS Flexible Plate | Comparison | | | | -General tissue reconstructions | -Muscle flap reinforcement -General tissue reconstructions | | | | | | Material | Polydioxanone (PDO) filament | 67% polyglycolic acid (PGA): 33% trimethylene carbonate (TMC) | Polydioxanone (PDO) thread | ePTFE | Polydioxanone | Equivalent to reference devices K181094 and K092590 | | Use | Single Use | Single Use | Single Use | Single Use | Single Use | Equivalent to predicate and reference devices K181094, K963619 and K092590 | | Sterilization Mode & SAL | Ethylene Oxide, SAL 10-6 | Gamma, SAL 10-6 | Ethylene Oxide, SAL 10-6 | Steam, SAL 10-6 | Ethylene Oxide, SAL 10-6 | Equivalent to reference devices K181094 and K092590 | | Biodegradable | Yes | Yes | Yes | No | Yes | Equivalent to predicate and reference devices K181094 and K092590 | | Primary Mechanism of Degradation | Degradation via hydrolysis | Degradation via hydrolysis | Degradation via bulk hydrolysis | None | Degradation via hydrolysis | Equivalent to predicate and reference devices K181094 and K092590 | | Biocompatible | Yes | Yes | Yes | Yes | Yes | Equivalent to predicate and reference devices K181094, K963619 and K092590 | | 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 | Not available | Double sterile barrier HDPE trays with TYVEK® packaging lids | Not available | Equivalent to predicate | | Shelf Life | 6 weeks | 3 years | Not available | >3 years | Not available | Difference does not raise different questions of safety or effectiveness | | Bioabsorption | 6-7 months | 6-7 months | 9 months | None | 6 months | Equivalent to predicate and reference | | | Subject Device - 3DMatrix | Predicate- Gore® Bio-A® Tissue Reinforcement | Reference Device Polydioxano ne Surgical Scaffold™ | Reference Device - Gore® GORE-TEX® SOFT TISSUE PATCH | Reference Device - PDS Flexible Plate | Comparison | | Storage | Room Temperature | Room Temperature | Room Temperature | Room Temperature | Below 25°C | device K092590 Equivalent to predicate and reference devices K181094 and K963619 | | Shape | Rectangular | Rectangular, Square | Not available | Rectangular, Square | Rectangular | Equivalent to predicate and reference devices K963619 and K092590 | | Size (LxW) | 60 x 55 mm 60 x 145 mm | 70 x 100 mm 80 x 80 mm 90 x 150 mm 100 x 300 mm 200 x 200 mm 200 x 300 mm | Not available | 50 x 100 mm 50 x 150 mm 100 x 150 mm 150 x 200 mm 200 x 300 mm | 40 x 50 mm | Difference does not raise different questions of safety or effectiveness; within range of sizes across predicate and reference devices K963619 and K092590 | | Thickness | 0.6 mm | 1.57 ± 0.02 mm | Not available | 1 or 2 mm | 0.5 mm | Equivalent to reference device K092590 | | Density | 392 g/m² | Not available | Not available | 400 g/m² | 625 g/m² | Equivalent to reference device K963610 | Table 1. Predicate and Reference Device Comparison Table - Technological Characteristics {5}------------------------------------------------ {6}------------------------------------------------ #### SUMMARY OF PERFORMANCE DATA 8 The data submitted in this application included benchtop and animal studies on biocompatibility, performance, packaging, sterilization, and shelf-life testing. 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 resulting data demonstrate that 3DMatrix functions as intended and performs comparably to the predicate device currently marketed for the same intended use. 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 {7}------------------------------------------------ Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued September 4, 2020). #### CONCLUSIONS 9 Nonclinical testing results demonstrate that the device is as safe, as effective, and performs at least as well as the legally marketed predicate and reference devices identified in Section 4 of this summary. The data support that the 3DMatrix device is substantially equivalent to the predicate device in terms of intended/indications for use, design, materials, function, biocompatibility, and sterilization.

3DMatrix Surgical Mesh

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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3DMatrix Surgical Mesh

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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