510(k) Report

Devices descending from K191028

7 later devices reach KLS Martin Individual Patient Solutions through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemMedcad20230—
+1K210731KLS Martin Individual Patient SolutionsKLS-Martin L.P.20223—
+1K203282TECHFIT Patient-Specific Maxillofacial SystemIndustrias Medicas Sampedro S.A.S20211—
+2K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+2K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.20260—
+2K232350Stryker Facial iD SystemStryker Craniomaxillofacial20240—
+2K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—