510(k) Report

Devices descending from K123795

13 later devices reach Axon-Bus Prosthetic System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240884Glide (91000-GL-X)Infinite Biomedical Technologies, LLC20241—
+1K220002Dexus Prosthetics System (Model: MSL1, MSR1)Zhejiang Qiangnao Technology Co.,Ltd20223—
+1K182757Espire Elbow Pro, Espire Elbow HybridCollege Park Industries, Inc.20180—
+1K173571Element System with IBT ElectrodesInfinite Biomedical Technologies, LLC20180—
+1K162891Complete Control SystemCoapt, LLC20177—
+2K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd20260—
+2K253256myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial…Otto Bock Healthcare Products GmbH20260—
+2K242326Wave Electrode (AE02-60); Wave Electrode (AE02-50)Bionit Labs Srl20251—
+2K191083COMPLETE CONTROL System Gen2Coapt, LLC20193—
+2K182112Sense System with IBT ElectrodesInfinite Biomedical Technologies, LLC20182—
+3K260453Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)Bionit Labs Srl20260—
+3K223738Alpha Control Liner System (ACLS)Coapt20232—
+3K191179Myo PlusOtto Bock Healthcare Products GmbH20191—