510(k) Report

Devices descending from K191005

18 later devices reach ProLift® Expandable System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+1K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+1K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+1K193258ProLift Expandable SystemLife Spine, Inc.20203—
+2K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+2K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+2K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+2K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+2K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+2K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+3K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—