Medacta International S.A. · Class II · Cleared Feb 26, 2026
| K-number | K253328 |
| Device name | GMK 3D Metal Tibial Tray Extension |
| Applicant | Medacta International S.A. |
| Product code | MBH |
| Device class | Class II |
| Decision date | Feb 26, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3565 |
The GMK 3D Metal Tibial Tray Extension is a sterile, single-use knee implant component designed for use in total knee arthroplasty procedures. It can be used with both cemented and cementless fixation techniques and is indicated for patients with severely painful or disabled joints due to arthritis, collagen disorders, avascular necrosis, post-traumatic joint loss, or primary implantation failure.
The subject and predicate devices are substantially equivalent in sizes, design, primary and secondary stability, materials (titanium alloy Ti-6Al-4V), surface finishing, biocompatibility, device usage, sterility, shelf-life, and packaging. The only difference is the manufacturing process: the subject device uses Direct Metal Laser Sintering (DMLS) while manufacturing specifics for the predicate are not detailed, but mechanical performance is not affected.
ASTM F1147-05(2017)e1 (tension test), ASTM F1044-05(2017)e1 (static shear test), ASTM F1160-14(2017)e1 (dynamic shear test), ASTM F1978-18 (Taber abrasion resistance), ASTM F1800-19e1 (dynamic endurance fatigue test), European Pharmacopoeia §2.6.14 (bacterial endotoxin test), and USP chapters <85>, <161>, and <151> (pyrogenicity testing).
View the full FDA submission: accessdata.fda.gov