Medacta International S.A. · Class II · Cleared Apr 28, 2026
| K-number | K253940 |
| Device name | M.U.S.T. Pedicle Screw System - Extension |
| Applicant | Medacta International S.A. |
| Product code | NKB |
| Device class | Class II |
| Decision date | Apr 28, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3070 |
The M.U.S.T. Pedicle Screw System - Extension is a spinal fixation system intended for posterior non-cervical pedicle fixation (T1-S2/ilium) and anterolateral fixation (T8-L5) as an adjunct to fusion. It is indicated for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients. The system comprises pedicle screws, connectors, hooks, rods, and cross-connectors made of titanium alloys or cobalt-chromium.
The subject device shares indications, design of MC cross-connectors, S2AI pedicle screws, and pre-contoured rods with predicates, with identical materials, coatings, biocompatibility, usage, packaging, shelf-life, and sterilization. It differs in the range of products offered and the design of rod-to-rod connectors, lateral connectors, and hooks, with new compatibility specifications for titanium setscrews and expanded screw sizes (Ø7-10) and length ranges.
ASTM F1717 (static and dynamic compression and torsion strength testing); ASTM F1798 (axial gripping tests for hooks and screws); ASTM F2193 (dynamic four-point bending test for spinal rods); European Pharmacopoeia §2.6.14 (bacterial endotoxin/LAL testing); USP chapters <85>, <151>, and <161> (pyrogenicity and endotoxin testing).
View the full FDA submission: accessdata.fda.gov