Medacta International S.A. · Class II · Cleared May 5, 2026
| K-number | K254202 |
| Device name | MectaLIF 3D Metal Anterior |
| Applicant | Medacta International S.A. |
| Product code | OVD |
| Device class | Class II |
| Decision date | May 5, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The MectaLIF 3D Metal Anterior is an intervertebral body fusion device for treating degenerative disc disease at one or two contiguous spinal levels (L2-S1). It consists of additively manufactured titanium alloy cages and low-profile antibackout cover plates, intended to be used with bone screws for lumbar anterior interbody fusion surgery.
Key differences from predicates include: additively manufactured Ti6Al4V cages (versus traditionally manufactured), a 25° endplate shape option, saw-tooth endplate surface design, redesigned low-profile antibackout cover plates in multiple heights with color coding, and different coupling mechanisms with flush plates. Material and sterilization remain substantially similar to predicates.
ASTM F2077-18, ASTM F2267-04, ISO 23089 (mechanical testing); ISO 17853 (wear analysis); European Pharmacopoeia §2.6.14 and USP chapter <151> (pyrogenicity); ISO 11607-1 and ISO 11607-2 (shelf-life validation).
The subject device is substantially equivalent because the additively manufactured cages and redesigned cover plates do not introduce new safety or effectiveness risks compared to predicate devices K232123, K124034, K160605, K170455, and K221545. Design changes (endplate shape, surface texture, plate design) maintain equivalent mechanical function and locking mechanisms, supported by comprehensive performance testing demonstrating no new worst-case scenarios.
View the full FDA submission: accessdata.fda.gov