510(k) Report

Devices descending from K241011

5 later devices reach Mako Total Knee Application through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250608Mako Total Knee Application (3.0); Hybrid Tip PointerMako Surgical Corp.20251—
+1K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+2K260222Mako Total Knee ApplicationMako Surgical Corp.20260—
+2K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG20261—
+3K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—