510(k) Report

Devices descending from K201538

13 later devices reach Life Spine SIMPACT Sacroiliac Joint Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+1K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+1K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+1K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+1K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+2K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+2K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+2K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+3K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+3K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+4K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+4K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—