510(k) Report

Devices descending from K192121

13 later devices reach Black Diamond Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+2K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+2K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+2K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+2K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—