Mako Surgical Corporation
FDA Regulatory Profile
Mako Surgical Corporation appears in FDA public data with 27 recalls, 8 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1735-2022, Class II) was initiated on August 8, 2022. Its most recent 510(k) clearance was granted on September 16, 2015.
Summary
- Total Recalls
- 27
- 510(k) Clearances
- 8
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1735-2022 | Class II | Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Ar | August 8, 2022 |
| Z-0472-2021 | Class II | Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 a | October 23, 2020 |
| Z-2745-2020 | Class II | Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167 | July 9, 2020 |
| Z-1824-2019 | Class II | 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Applicatio | April 25, 2019 |
| Z-1823-2019 | Class II | 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) | April 25, 2019 |
| Z-2925-2018 | Class II | Stryker Mako Vizadisc Hip Procedure Tracking Kit | July 24, 2018 |
| Z-2924-2018 | Class II | Stryker Mako Vizadisc Knee Procedure Tracking Kit | July 24, 2018 |
| Z-2794-2018 | Class II | Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Applicati | May 10, 2018 |
| Z-2051-2018 | Class II | Restoris MCK Onlay Insert Extractor. | January 19, 2018 |
| Z-3182-2018 | Class II | Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: | December 27, 2017 |
| Z-1644-2018 | Class II | RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements | December 1, 2017 |
| Z-3131-2017 | Class II | Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) | August 7, 2017 |
| Z-3130-2017 | Class II | Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic | August 7, 2017 |
| Z-2741-2017 | Class II | MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in p | June 7, 2017 |
| Z-1411-2017 | Class II | MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery. | December 22, 2016 |
| Z-1193-2017 | Class II | Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to h | September 29, 2016 |
| Z-1583-2016 | Class II | RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpos | February 23, 2016 |
| Z-1031-2016 | Class II | Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compa | January 15, 2016 |
| Z-1588-2016 | Class II | MAKOplasty Hip Array Kit Laminate 150230 | November 25, 2015 |
| Z-0224-2016 | Class II | Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (co | July 16, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K142530 | Partial Knee Application (PKA) | September 16, 2015 |
| K150410 | RESTORIS POROUS PARTIAL KNEE SYSTEM | March 20, 2015 |
| K141989 | MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM | November 13, 2014 |
| K133039 | RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM | December 10, 2013 |
| K121064 | MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM | June 6, 2012 |
| K112507 | RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM | March 1, 2012 |
| K090763 | RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM | June 17, 2009 |
| K082172 | MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM | November 28, 2008 |