| K-number | K251016 |
| Device name | MectaLIF 3D Metal |
| Applicant | Medacta International S.A. |
| Product code | MAX |
| Device class | Class II |
| Decision date | Jul 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The MectaLIF 3D Metal is an intervertebral body fusion device made of additively manufactured titanium alloy (Ti6Al4V) for lumbar spine surgery. It is used with supplemental fixation and autogenous bone graft to treat degenerative disc disease at one or two contiguous spinal levels (L2–S1) in patients who have failed conservative management.
The device is substantially equivalent to predicate devices in range, design, endplate shape (except dome), biocompatibility, usage, packaging, and sterilization. Key differences include: saw-tooth endplate surface (vs. pyramids), bone graft volume slightly varied (<9% difference in smallest size), titanium alloy material (vs. PEEK/TiPEEK), and current 5-year shelf-life with validation for 10-year extension.
ASTM F2077-18, ASTM F2267-04, ISO 23089-2, ISO 17853:2011, ASTM F1877-16, ASTM F1854-15, ASTM F1978-22, ASTM F1147-05, ASTM F1044-05, European Pharmacopoeia §2.6.14, USP chapter <85>, USP chapter <151>, ISO 11607-1, ISO 11607-2.
The subject device shares identical intended use, design principles, and sterilization with predicates. The novel titanium material and additive manufacturing process are already established in reference devices (K202568, K221850) cleared through prior 510(k)s. Mechanical testing confirms saw-tooth endplates achieve equivalent lordosis and backout resistance to pyramid endplates. The minimal bone graft volume difference (<9%) does not raise new safety concerns. Biocompatibility and shelf-life validation follow established predicate precedent.
View the full FDA submission: accessdata.fda.gov