Mako Surgical Corporation
Medical device manufacturer in Weston, FL.
42510(k) clearances
0PMA approvals
31recalls
Device types
- OLO Orthopedic Stereotaxic Instrument 23
- HSX Prosthesis, Knee, Femorotibial… 6
- HAW Neurological Stereotaxic Instrument 4
- NPJ Prosthesis, Knee Patellofemorotibial… 3
- KRR Prosthesis, Knee, Patello/Femoral… 2
- NJD Prosthesis, Knee, Femorotibial… 1
- LPH Prosthesis, Hip, Semi-Constrained… 1
- JWH Prosthesis, Knee, Patellofemorotibial… 1
- HRY Prosthesis, Knee, Femorotibial… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260222 | Mako Total Knee ApplicationOLO · Special | 02/25/2026SE |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip PointerOLO · Traditional | 04/25/2025SE |
| K243751 | Mako Total Hip Application 5.0OLO · Traditional | 03/05/2025SE |
| K242373 | Mako Shoulder Application (1.0)OLO · Traditional | 11/07/2024SE |
| K241011 | Mako Total Knee ApplicationOLO · Traditional | 06/11/2024SE |
| K220930 | Restoris Multi-Compartmental Knee SystemHSX · Traditional | 06/02/2022SE |
| K220459 | Mako Total Knee ApplicationOLO · Traditional | 04/15/2022SE |
| K193515 | Mako Total Knee ApplicationOLO · Traditional | 07/14/2020SE |
| K193128 | Mako Total Hip ApplicationOLO · Traditional | 02/02/2020SE |
| K191998 | Mako Total Hip Application, Mako Total Knee ApplicationOLO · Traditional | 09/24/2019SE |
| K172301 | Mako Partial Knee ApplicationOLO · Special | 11/02/2017SE |
| K172219 | Mako Total Knee ApplicationOLO · Traditional | 09/21/2017SE |
| K170891 | Mako Partial Knee ApplicationOLO · Traditional | 05/24/2017SE |
| K170584 | Mako Partial Knee ApplicationOLO · Special | 05/11/2017SE |
| K170581 | Mako Total Knee ApplicationOLO · Special | 05/11/2017SE |
| K170593 | Mako Total Hip ApplicationOLO · Special | 04/18/2017SE |
| K142530 | Partial Knee Application (PKA)OLO · Traditional | 09/16/2015SE |
| K143752 | Total Knee Application (TKA)OLO · Traditional | 08/06/2015SE |
| K150410 | Restoris Porous Partial Knee SystemHRY · Special | 03/20/2015SE |
| K150307 | RESTORIS Multicompartmental Knee SystemNPJ · Special | 03/10/2015SE |
| K143635 | KINETIS Total Knee SystemJWH · Traditional | 02/20/2015SE |
| K142606 | Trident® Tritanium® PST® Acetabular ShellsLPH · Traditional | 01/26/2015SE |
| K141989 | Makoplasty Total Hip Allpication, Rio Standard SystemOLO · Special | 11/13/2014SE |
| K133811 | Restoris Porous Partial Knee SystemNJD · Traditional | 07/08/2014SE |
| K133039 | Restoris Multicompartmental Knee SystemNPJ · Special | 12/10/2013SE |
| K121064 | Makoplasty Total Hip Application, Rio Standard SystemOLO · Special | 06/06/2012SE |
| K112507 | Restoris Partial Knee Application (Pka), Rio Standard SystemOLO · Traditional | 03/01/2012SE |
| K093425 | Mako Surgical Corp Robotic Arm Interactive Orthopedic System-ThaOLO · Traditional | 02/24/2010SE |
| K091998 | Robotic Arm Interactive Orthopedic System-HipOLO · Traditional | 09/28/2009SE |
| K083644 | Mako Surgical Tactile Guidance System-HipOLO · Traditional | 06/19/2009SE |
| K090763 | Restoris Multicompartmental Knee (MCK) SystemNPJ · Traditional | 06/17/2009SE |
| K082172 | Mako Modular Knee Compartmental Implant SystemHSX · Traditional | 11/28/2008SE |
| K081867 | Mako Surgical Tactile Guidance System Version 2.0HAW · Traditional | 11/25/2008SE |
| K082088 | Mako Surgical Corp. Patellofemoral Knee Implant System IIKRR · Traditional | 10/22/2008SE |
| K082081 | Mako Surgical Corporation Unicondylar Knee Implant System IIIHSX · Traditional | 10/15/2008SE |
| K080368 | Mako Surgical Corp. Unicondylar Knee Implant System IIHSX · Traditional | 06/20/2008SE |
| K080029 | Mako Surgical Corp. Patellofemoral Knee Implant SystemKRR · Traditional | 05/16/2008SE |
| K072806 | Mako Surgical Tactile Guidance System (TGS)HAW · Traditional | 01/24/2008SE |
| K073248 | Modification To:Mako Surgical Unicondylar Knee SystemHSX · Special | 12/12/2007SE |
| K060017 | Mako Surgical Unicondylar Knee SystemHSX · Traditional | 02/23/2006SE |
| K052851 | Voyager Linux with Tactile Guidance System (TGS)HAW · Special | 11/18/2005SE |
| K050973 | Modification to: Voyager LinuxHAW · Special | 05/17/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1735-2022 Class II | Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako…Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have… | 08/08/2022Terminated |
| Z-0472-2021 Class II | Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software…Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS)… | 10/23/2020Completed |
| Z-2745-2020 Class II | Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167Characterization issue associated with the product. This issue may cause a discrepancy during bone… | 07/09/2020Terminated |
| Z-1824-2019 Class II | 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial…The bearings of the saw attachments were ungreased. | 04/25/2019Terminated |
| Z-1823-2019 Class II | 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)The bearings of the saw attachments were ungreased. | 04/25/2019Terminated |
| Z-2925-2018 Class II | Stryker Mako Vizadisc Hip Procedure Tracking KitSpecific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the… | 07/24/2018Terminated |
| Z-2924-2018 Class II | Stryker Mako Vizadisc Knee Procedure Tracking KitSpecific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the… | 07/24/2018Terminated |
| Z-2794-2018 Class II | Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee…Out of tolerance. | 05/10/2018Terminated |
| Z-2051-2018 Class II | Restoris MCK Onlay Insert Extractor.Possible hinge pin disassociation from the Mako Onlay Insert Extractor. | 01/19/2018Terminated |
| Z-3182-2018 Class II | Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933…Communication-connection error. | 12/27/2017Terminated |
| Z-1644-2018 Class II | RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee…Incorrect product and/or label. Sizing is labeled incorrectly. | 12/01/2017Terminated |
| Z-3131-2017 Class II | Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System…Software discrepancy of not showing all the EE constants, when the screen is filled. | 08/07/2017Terminated |
| Z-3130-2017 Class II | Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive…Software discrepancy of not showing all the EE constants, when the screen is filled. | 08/07/2017Terminated |
| Z-2741-2017 Class II | MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the…An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection. | 06/07/2017Terminated |
| Z-1411-2017 Class II | MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides | 12/22/2016Terminated |
| Z-1193-2017 Class II | Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is…Failure of the Offset Cup Reamer Handle not engaging its mating components. | 09/29/2016Terminated |
| Z-1583-2016 Class II | RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for…Potential disassociation of the orientation pin. | 02/23/2016Terminated |
| Z-1031-2016 Class II | Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or…Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration… | 01/15/2016Terminated |
| Z-1588-2016 Class II | MAKOplasty Hip Array Kit Laminate 150230Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit… | 11/25/2015Terminated |
| Z-0224-2016 Class II | Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and…The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector. | 07/16/2015Terminated |
| Z-1128-2015 Class II | Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm…When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the… | 01/22/2015Terminated |
| Z-0830-2015 Class II | RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument…MAKO has identified the potential that the shell impactors may be damaged intraoperatively. | 10/07/2014Terminated |
| Z-0829-2015 Class II | RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument…MAKO has identified the potential that the shell impactors may be damaged intraoperatively. | 10/07/2014Terminated |
| Z-0828-2015 Class II | RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for…MAKO has identified the potential that the shell impactors may be damaged intraoperatively. | 10/07/2014Terminated |
| Z-1508-2016 Class II | Robotic Arm Interactive Orthopedic System (RIO)Revision of the field manual | 04/30/2014Terminated |
| Z-1132-2014 Class II | Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used…The product may be mislabeled and could result in the incorrect implant being used. | 01/09/2014Terminated |
| Z-0385-2013 Class II | The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist…MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5… | 09/12/2012Terminated |
| Z-0146-2012 | Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL…MAKO Surgical Corp. is recalling their RIO Robotic Arm Interactive Orthopedic System (RIO) due to software… | 01/20/2011Terminated |
| Z-2232-2011 | MAKO PN 204588 Camera 204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX…MAKO Surgical Corporation recalled ONE infra-red camera MAKO PN 204854 which was a component of their RIO… | 10/25/2010Terminated |
| Z-0064-2010 | 200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance…Cables fail to provide adequate transmission. MAKO Surgical Corporation is recalling 200996 Cable Assembly… | 07/17/2009Terminated |
| Z-0915-2009 | Tibial Array and Femoral Array. Model Number(s): 0150ARR00001 and 0150ARR00002.…The product in its current state may fail during use, which would cause the instrument to be in-accurate. | 05/02/2008Terminated |