510(k) Report

Devices descending from K222789

5 later devices reach VADER® Pedicle System, G21 Cement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+1K232628VADER® Pedicle SystemIcotec AG20241—
+2K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+2K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+2K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—