3DMatrix DynaFlex (DynaFlex)

The 3DMatrix DynaFlex is a fully absorbable surgical mesh made of polydioxanone (PDO) used to reinforce soft tissue during plastic and reconstructive surgery. It is provided in three sizes, can be cut to fit each application, and degrades over 6-7 months while providing temporary mechanical support and a scaffold for tissue ingrowth. Intended uses include suture line reinforcement, hernia repair, muscle flap reinforcement, and general tissue reconstruction.

DynaFlex is identical to the predicate 3DMatrix in material composition (PDO), manufacturing methods, packaging, sterilization mode (ethylene oxide, SAL 10-6), and bioabsorption timeline (6-7 months). The key differences are higher pore size (7.5 ± 0.2 mm² vs. 1.21 mm²), lower density (289 g/m² vs. 392 g/m²), and bi-directional mechanical properties (versus the predicate's non-isotropic properties). These differences are characteristic of other FDA-cleared surgical meshes with similar indications.

Testing followed ASTM D6797-15 (ball burst strength), ASTM D2261-13 (tear strength), ASTM D5035-11 (tensile strength), and internal test methods for suture pull-out strength. Biocompatibility testing complied with Good Laboratory Practice (21 CFR Part 58) and FDA Guidance for ISO 10993-1, addressing all endpoints required for long-term implant devices with tissue and bone contact.

DynaFlex is substantially equivalent because it has identical indications, principle of operation, material composition, manufacturing methods, and sterilization to the predicate 3DMatrix. Nonclinical testing demonstrated equivalent mechanical performance, degradation kinetics, and in vivo bioabsorption. The differences in pore size, density, and bi-directional mechanics do not raise new safety or effectiveness concerns because these same variations exist among other FDA-cleared surgical meshes with substantially similar indications for use.