510(k) Report

Devices descending from K081252

44 later devices reach Expedium 4.5MM Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+1K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+1K150417Astra Spine SystemSpinecraft, LLC201521—
+1K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+1K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+1K100757Tilock Pedicle Screw SystemGenesys Spine201091
+1K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K223273ASTRA Spine SystemSpinecraft, LLC20228—
+2K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+2K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K211323ASTRA Spine SystemSpinecraft, LLC202112—
+2K172469TiLock Modular Spinal SystemGenesys Spine20170—
+2K171838TiLock2 Spinal SystemGenesys Spine20174—
+2K162786PASS LP Spinal SystemMedicrea International SA20176—
+2K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+2K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+2K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+2K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+2K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+2K103671Genesys Spine Tilock SystemGenesys Spine20118—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K252322SIros-X SystemGenesys Spine20250—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+3K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+5K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—