Mako Surgical Corporation

FDA Regulatory Profile

Summary

Total Recalls
27
510(k) Clearances
8
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1735-2022Class IIStryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-ArAugust 8, 2022
Z-0472-2021Class IIMako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 aOctober 23, 2020
Z-2745-2020Class IIMako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167July 9, 2020
Z-1823-2019Class II2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)April 25, 2019
Z-1824-2019Class II2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee ApplicatioApril 25, 2019
Z-2924-2018Class IIStryker Mako Vizadisc Knee Procedure Tracking KitJuly 24, 2018
Z-2925-2018Class IIStryker Mako Vizadisc Hip Procedure Tracking KitJuly 24, 2018
Z-2794-2018Class IIRio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee ApplicatiMay 10, 2018
Z-2051-2018Class IIRestoris MCK Onlay Insert Extractor.January 19, 2018
Z-3182-2018Class IIMakoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage:December 27, 2017
Z-1644-2018Class IIRESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacementsDecember 1, 2017
Z-3130-2017Class IIMakoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic August 7, 2017
Z-3131-2017Class IITotal Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) August 7, 2017
Z-2741-2017Class IIMAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in pJune 7, 2017
Z-1411-2017Class IIMAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.December 22, 2016
Z-1193-2017Class IIStryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hSeptember 29, 2016
Z-1583-2016Class IIRESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purposFebruary 23, 2016
Z-1031-2016Class IIRestoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compaJanuary 15, 2016
Z-1588-2016Class IIMAKOplasty Hip Array Kit Laminate 150230November 25, 2015
Z-0224-2016Class IIRobotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (coJuly 16, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K142530Partial Knee Application (PKA)September 16, 2015
K150410RESTORIS POROUS PARTIAL KNEE SYSTEMMarch 20, 2015
K141989MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEMNovember 13, 2014
K133039RESTORIS MULTICOMPARTMENTAL KNEE SYSTEMDecember 10, 2013
K121064MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMJune 6, 2012
K112507RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEMMarch 1, 2012
K090763RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMJune 17, 2009
K082172MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEMNovember 28, 2008