3DMatrix Surgical Mesh
510(k) K232602
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232602 | Date23 May 2024 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OXF
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The 3DMatrix Surgical Mesh is a resorbable, absorbable surgical mesh designed for use in plastic and reconstructive surgery. Classified as a Class II device under FDA regulations, it is intended for soft tissue reinforcement and repair, providing structural support during wound healing. Its 3D-printed construction enables customizable mechanical properties tailored to surgical needs, distinguishing it from traditional woven or knitted meshes. The device falls under the product code OXF, aligning with absorbable mesh applications in soft tissue procedures.
This mesh is supplied in sterile, single-use packaging and is intended for surgical use only. It is manufactured by PrintBio, Inc., and holds FDA 510(k) clearance as substantially equivalent to predicate devices. The mesh is resorbable, meaning it gradually breaks down and is absorbed by the body over time, eliminating the need for removal. Sizes and configurations are standardized for compatibility with common surgical techniques in plastic and reconstructive surgery, with regulatory compliance ensured through FDA review by the Surgical and Urological Devices Panel.
Other devices from Printbio, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the 3DMatrix Surgical Mesh used for?
The 3DMatrix Surgical Mesh is designed specifically for soft tissue reinforcement and repair in plastic and reconstructive surgery. Its 3D-printed structure allows for customizable mechanical properties, providing targeted structural support during wound healing. This makes it ideal for procedures requiring precise reinforcement without the need for permanent implants.
How is the 3DMatrix Surgical Mesh supplied and prepared for use?
The mesh is supplied in sterile, single-use packaging, ensuring safety and compliance with surgical standards. It is intended exclusively for surgical use and does not require additional preparation beyond standard sterile field protocols. The packaging maintains sterility until opened in the operating room.
Is the 3DMatrix Surgical Mesh resorbable, and what does that mean for patients?
Yes, the 3DMatrix Surgical Mesh is resorbable, meaning it gradually breaks down and is absorbed by the body over time. This eliminates the need for a secondary surgical procedure to remove the mesh, reducing patient risk and recovery time. The resorbable nature aligns with the body’s natural healing process.
What sizes and configurations are available for the 3DMatrix Surgical Mesh?
The mesh comes in standardized sizes and configurations tailored to common techniques in plastic and reconstructive surgery. While exact dimensions are not specified, the design ensures compatibility with typical surgical requirements. Customization is achieved through the 3D-printed construction, allowing for adaptability to specific patient needs within predefined standards.
How is the regulatory compliance of the 3DMatrix Surgical Mesh ensured?
The mesh holds FDA 510(k) clearance, demonstrating it is substantially equivalent to predicate devices under the product code OXF for absorbable mesh applications. It was reviewed by the Surgical and Urological Devices Panel (SU) and complies with Class II device regulations. This ensures adherence to rigorous safety and performance standards for surgical use.