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MAKO Surgical Corp.

United States·US-MF-000000703

Last updated September 17, 2026

Information

Country: United States
Address: 3365, Enterprise Avenue, Weston, United States
Website: www.stryker.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 954 927 2044
PRRC Contact: Krutanjali Shah
EUDAMED SRN: US-MF-000000703
FDA FEI Number: 3005985723
DUNS Number: —

Catalogue (874)

Page 18 of 18

Device	Model / Reference	Registries	Class	Status
Makoplasty Total Hip Allpication, Rio Standard System	K141989	FDA 510(k)	Class II	Active
Robotic Arm Interactive Orthopedic System-Hip	K091998	FDA 510(k)	Class II	Active
Mako Total Hip Application	K193128	FDA 510(k)	Class II	Active
Trident® Tritanium® PST® Acetabular Shells	K142606	FDA 510(k)	Class II	Active
Mako Total Knee Application	K193515	FDA 510(k)	Class II	Active
Mako Total Hip Application	K170593	FDA 510(k)	Class II	Active
Mako Surgical Tactile Guidance System Version 2.0	K081867	FDA 510(k)	Class II	Active
Mako Surgical Tactile Guidance System (tgs)	K072806	FDA 510(k)	Class II	Active
Mako Surgical Corp. Patellofemoral Knee Implant System	K080029	FDA 510(k)	Class II	Active
Total Knee Application (TKA)	K143752	FDA 510(k)	Class II	Active
Restoris Partial Knee Application (pka), Rio Standard System	K112507	FDA 510(k)	Class II	Active
Mako Total Knee Application	K170581	FDA 510(k)	Class II	Active
Mako Surgical Corp. Unicondylar Knee Implant System Ii	K080368	FDA 510(k)	Class II	Active
Mako Total Knee Application (3.0); Hybrid Tip Pointer	K250608	FDA 510(k)	Class II	Active
Restoris Multi-Compartmental Knee System	K220930	FDA 510(k)	Class II	Active
Mako Total Hip Application, Mako Total Knee Application	K191998	FDA 510(k)	Class II	Active
Makoplasty Total Hip Application, Rio Standard System	K121064	FDA 510(k)	Class II	Active
Mako Partial Knee Application	K170584	FDA 510(k)	Class II	Active
Modification To:mako Surgical Unicondylar Knee System	K073248	FDA 510(k)	Class II	Active
Mako Total Knee Application	K241011	FDA 510(k)	Class II	Active
Mako Surgical Corp Robotic Arm Interactive Orthopedic System-Tha	K093425	FDA 510(k)	Class II	Active
Restoris Multicompartmental Knee System	K133039	FDA 510(k)	Class II	Active
Mako Total Knee Application	K172219	FDA 510(k)	Class II	Active
Restoris Porous Partial Knee System	K150410	FDA 510(k)	Class II	Active

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FDA Recalls (31)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 8, 2022	Z-1735-2022	—	open, classified	Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.
Oct 23, 2020	Z-0472-2021	—	completed	Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). This issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. This issue may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mako Partial Knee procedure in which the surgeon uses a straight or angled saw attachment with the MICS Handpiece. The surgeon may make cuts during bone preparation that differ from the surgeon s preoperative plan.
Jul 9, 2020	Z-2745-2020	—	terminated	Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.
Apr 25, 2019	Z-1824-2019	—	terminated	The bearings of the saw attachments were ungreased.
Apr 25, 2019	Z-1823-2019	—	terminated	The bearings of the saw attachments were ungreased.
Jul 24, 2018	Z-2925-2018	—	terminated	Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.
Jul 24, 2018	Z-2924-2018	—	terminated	Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.
May 10, 2018	Z-2794-2018	—	terminated	Out of tolerance.
Jan 19, 2018	Z-2051-2018	—	terminated	Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Dec 27, 2017	Z-3182-2018	—	terminated	Communication-connection error.
Dec 1, 2017	Z-1644-2018	—	terminated	Incorrect product and/or label. Sizing is labeled incorrectly.
Aug 7, 2017	Z-3131-2017	—	terminated	Software discrepancy of not showing all the EE constants, when the screen is filled.
Aug 7, 2017	Z-3130-2017	—	terminated	Software discrepancy of not showing all the EE constants, when the screen is filled.
Jun 7, 2017	Z-2741-2017	—	terminated	An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
Dec 22, 2016	Z-1411-2017	—	terminated	Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
Sep 29, 2016	Z-1193-2017	—	terminated	Failure of the Offset Cup Reamer Handle not engaging its mating components.
Feb 23, 2016	Z-1583-2016	—	terminated	Potential disassociation of the orientation pin.
Jan 15, 2016	Z-1031-2016	—	terminated	Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
Nov 25, 2015	Z-1588-2016	—	terminated	Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.
Jul 16, 2015	Z-0224-2016	—	terminated	The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
Jan 22, 2015	Z-1128-2015	—	terminated	When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated
Oct 7, 2014	Z-0830-2015	—	terminated	MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Oct 7, 2014	Z-0828-2015	—	terminated	MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Oct 7, 2014	Z-0829-2015	—	terminated	MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Apr 30, 2014	Z-1508-2016	—	terminated	Revision of the field manual
Jan 9, 2014	Z-1132-2014	—	terminated	The product may be mislabeled and could result in the incorrect implant being used.
Sep 12, 2012	Z-0385-2013	—	terminated	MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the system's software. Loss of tactile feedback constraining the cutting burr has been reported.
Jan 20, 2011	Z-0146-2012	—	terminated	MAKO Surgical Corp. is recalling their RIO Robotic Arm Interactive Orthopedic System (RIO) due to software issue that exist that could potentially result in a bone resection. No adverse events reported.
Oct 25, 2010	Z-2232-2011	—	terminated	MAKO Surgical Corporation recalled ONE infra-red camera MAKO PN 204854 which was a component of their RIO Robotic Arm Interactive Orthopedic System with SSN P7-03127, on November 22, 2010. This component can function improperly and cause the accuracy of the system to be outside of the specification listed by the manufacturer. The recall was initiated after the camera manufacture, NDI, Waterloo, On
Jul 17, 2009	Z-0064-2010	—	terminated	Cables fail to provide adequate transmission. MAKO Surgical Corporation is recalling 200996 Cable Assembly, Hybrid Extended Length; 200997 Cable Assembly, Hybrid, Guidance Module; and 200998 Cable Assembly, Hybrid, UI Panel. These parts are sub components of the 20300 Rio Standard System.
May 2, 2008	Z-0915-2009	—	terminated	The product in its current state may fail during use, which would cause the instrument to be in-accurate.