Mako Surgical Corp.
Weston, FL, US
MAKO SURGICAL CORP. appears in FDA device records in Weston, FL. FDA records list 42 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 31 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 42 510(k) clearances for Mako Surgical Corp. between 2005 and 2026. The busiest year on record is 2008, with 7. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 7 |
| 2009 | 3 |
| 2010 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 6 |
| 2017 | 6 |
| 2019 | 1 |
| 2020 | 2 |
| 2022 | 2 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260222 | Mako Total Knee Application | OLO | Substantially Equivalent | |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer | OLO | Substantially Equivalent | |
| K243751 | Mako Total Hip Application 5.0 | OLO | Substantially Equivalent | |
| K242373 | Mako Shoulder Application (1.0) | OLO | Substantially Equivalent | |
| K241011 | Mako Total Knee Application | OLO | Substantially Equivalent | |
| K220930 | Restoris Multi-Compartmental Knee System | HSX | Substantially Equivalent | |
| K220459 | Mako Total Knee Application | OLO | Substantially Equivalent | |
| K193515 | Mako Total Knee Application | OLO | Substantially Equivalent | |
| K193128 | Mako Total Hip Application | OLO | Substantially Equivalent | |
| K191998 | Mako Total Hip Application, Mako Total Knee Application | OLO | Substantially Equivalent | |
| K172301 | Mako Partial Knee Application | OLO | Substantially Equivalent | |
| K172219 | Mako Total Knee Application | OLO | Substantially Equivalent | |
| K170891 | Mako Partial Knee Application | OLO | Substantially Equivalent | |
| K170584 | Mako Partial Knee Application | OLO | Substantially Equivalent | |
| K170581 | Mako Total Knee Application | OLO | Substantially Equivalent | |
| K170593 | Mako Total Hip Application | OLO | Substantially Equivalent | |
| K142530 | Partial Knee Application (PKA) | OLO | Substantially Equivalent | |
| K143752 | Total Knee Application (TKA) | OLO | Substantially Equivalent | |
| K150410 | RESTORIS POROUS PARTIAL KNEE SYSTEM | HRY | Substantially Equivalent | |
| K150307 | RESTORIS Multicompartmental Knee System | NPJ | Substantially Equivalent | |
| K143635 | KINETIS Total Knee System | JWH | Substantially Equivalent | |
| K142606 | Trident® Tritanium® PST® Acetabular Shells | LPH | Substantially Equivalent | |
| K141989 | MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM | OLO | Substantially Equivalent | |
| K133811 | RESTORIS POROUS PARTIAL KNEE SYSTEM | NJD | Substantially Equivalent | |
| K133039 | RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM | NPJ | Substantially Equivalent | |
| K121064 | MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM | OLO | Substantially Equivalent | |
| K112507 | RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM | OLO | Substantially Equivalent | |
| K093425 | MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA | OLO | Substantially Equivalent | |
| K091998 | ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP | OLO | Substantially Equivalent | |
| K083644 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP | OLO | Substantially Equivalent | |
| K090763 | RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM | NPJ | Substantially Equivalent | |
| K082172 | MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM | HSX | Substantially Equivalent | |
| K081867 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 | HAW | Substantially Equivalent | |
| K082088 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II | KRR | Substantially Equivalent | |
| K082081 | MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III | HSX | Substantially Equivalent | |
| K080368 | MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II | HSX | Substantially Equivalent | |
| K080029 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM | KRR | Substantially Equivalent | |
| K072806 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) | HAW | Substantially Equivalent | |
| K073248 | MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM | HSX | Substantially Equivalent | |
| K060017 | MAKO SURGICAL UNICONDYLAR KNEE SYSTEM | HSX | Substantially Equivalent | |
| K052851 | VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS) | HAW | Substantially Equivalent | |
| K050973 | MODIFICATION TO: VOYAGER LINUX | HAW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017410889 | 3005985723 | MAKO SURGICAL CORP. | 3365 ENTERPRISE AVE, Weston, FL 33331 US | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FQMBandage, Elastic
- KTZCaliper
- HTJGauge, Depth
- HAWNeurological Stereotaxic Instrument
- FWZOperating Room Accessories Table Tray
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- NJDProsthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
- KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- FMPProtector, Skin Pressure
- GADRetractor
- LRPTray, Surgical
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
Showing 25 of 31| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1735-2022 | Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System. | 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. | Class II | Terminated | |
| Z-0472-2021 | Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). | 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. | Class II | Completed | |
| Z-2745-2020 | Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167 | Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures. | Class II | Terminated | |
| Z-1824-2019 | 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0) | The bearings of the saw attachments were ungreased. | Class II | Terminated | |
| Z-1823-2019 | 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) | The bearings of the saw attachments were ungreased. | Class II | Terminated | |
| Z-2925-2018 | Stryker Mako Vizadisc Hip Procedure Tracking Kit | 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. | Class II | Terminated | |
| Z-2924-2018 | Stryker Mako Vizadisc Knee Procedure Tracking Kit | 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. | Class II | Terminated | |
| Z-2794-2018 | Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement. | Out of tolerance. | Class II | Terminated | |
| Z-2051-2018 | Restoris MCK Onlay Insert Extractor. | Possible hinge pin disassociation from the Mako Onlay Insert Extractor. | Class II | Terminated | |
| Z-3182-2018 | Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include Unicondylar knee replacement and/or patellofemoral knee replacement. | Communication-connection error. | Class II | Terminated | |
| Z-1644-2018 | RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements. | Incorrect product and/or label. Sizing is labeled incorrectly. | Class II | Terminated | |
| Z-3131-2017 | Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. | Software discrepancy of not showing all the EE constants, when the screen is filled. | Class II | Terminated | |
| Z-3130-2017 | Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. | Software discrepancy of not showing all the EE constants, when the screen is filled. | Class II | Terminated | |
| Z-2741-2017 | MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures. | An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection. | Class II | Terminated | |
| Z-1411-2017 | 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 | Class II | Terminated | |
| Z-1193-2017 | Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures. | Failure of the Offset Cup Reamer Handle not engaging its mating components. | Class II | Terminated | |
| Z-1583-2016 | RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery. | Potential disassociation of the orientation pin. | Class II | Terminated | |
| Z-1031-2016 | Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO. | Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier. | Class II | Terminated | |
| Z-1588-2016 | MAKOplasty Hip Array Kit Laminate 150230 | 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. | Class II | Terminated | |
| Z-0224-2016 | Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures. | The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector. | Class II | Terminated | |
| Z-1128-2015 | Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures. | 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 | Class II | Terminated | |
| Z-0830-2015 | RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery. | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. | Class II | Terminated | |
| Z-0829-2015 | RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery. | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. | Class II | Terminated | |
| Z-0828-2015 | RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery. | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. | Class II | Terminated | |
| Z-1508-2016 | Robotic Arm Interactive Orthopedic System (RIO) | Revision of the field manual | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain