510(k) Report

Devices descending from K083307

9 later devices reach Synthasome X-Repair through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141394X-RepairSynthasome20140—
+1K141499X-RepairslSynthasome, Inc.20140—
+1K121216STR GraftSoft Tissue Regeneration, Inc.20125—
+1K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+2K203267The BioBrace ImplantBiorez, Inc.20214—
+3K242187BioBrace®Conmed Corporation20241—
+3K241906BioBrace® Reinforced ImplantConmed Corporation20243—
+4K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—
+4K250395BioBrace ® RC Delivery SystemConmed Corporation20250—