510(k) Report

Devices descending from K121216

5 later devices reach STR Graft through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203267The BioBrace ImplantBiorez, Inc.20214—
+2K242187BioBrace®Conmed Corporation20241—
+2K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+3K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+3K250395BioBrace ® RC Delivery SystemConmed Corporation20250—