Data / Medical devices / United States / Mako Surgical Corp.
Mako Surgical Corp.: FDA-registered device maker in Weston, FL, United States, 35 510(k) clearances
Mako Surgical Corp. is registered with the FDA (registration 3017410889) in Weston, FL, United States. It lists 21 device types. The FDA files 35 510(k) clearances under its listings, the newest dated February 25, 2026. 26 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017410889
- FEI number
- 3005985723
- Address
- 3365 Enterprise Ave, Weston, FL, United States, 33331
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 29, 1977
- Registered through
- 2027
- Brand names listed
- 10mm SUBFIX TRIAL, 11.5mm SUBFIX TRIAL, 135 mm Reusable Slat, SE Retr, 10 Pack, 155 mm Reusable Slat, SE Retr, 10 Pack, 175mm Reusable Slat, SE Retr, 10 Pack, 206-716 w/2 small sculps/pkg, 234-112-100 VersiQuad Halo Retractor, 3MM DBL SLEEVE 80MM TROC/ASSY and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 25, 2026 | K260222 | Mako Total Knee Application | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| April 25, 2025 | K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| March 5, 2025 | K243751 | Mako Total Hip Application 5.0 | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| December 4, 2024 | K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System | JWH | Substantially Equivalent | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | accessdata.fda.gov |
| November 7, 2024 | K242373 | Mako Shoulder Application (1.0) | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| August 27, 2024 | K241517 | Q Guidance System; Mako Spine System; | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| June 11, 2024 | K241011 | Mako Total Knee Application | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| June 2, 2022 | K220930 | Restoris Multi-Compartmental Knee System | HSX | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| April 15, 2022 | K220459 | Mako Total Knee Application | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| July 14, 2020 | K193515 | Mako Total Knee Application | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| February 2, 2020 | K193128 | Mako Total Hip Application | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| September 24, 2019 | K191998 | Mako Total Hip Application, Mako Total Knee Application | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| June 7, 2018 | K180612 | Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts | HSX | Substantially Equivalent | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | accessdata.fda.gov |
| November 2, 2017 | K172301 | Mako Partial Knee Application | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| October 30, 2017 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | JWH | Substantially Equivalent | Stryker Orthopaedics | accessdata.fda.gov |
| September 21, 2017 | K172219 | Mako Total Knee Application | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| May 24, 2017 | K170891 | Mako Partial Knee Application | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| May 11, 2017 | K170584 | Mako Partial Knee Application | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| May 11, 2017 | K170581 | Mako Total Knee Application | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| April 18, 2017 | K170593 | Mako Total Hip Application | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| September 16, 2015 | K142530 | Partial Knee Application (PKA) | OLO | Substantially Equivalent | Mako Surgical Corporation | accessdata.fda.gov |
| August 6, 2015 | K143752 | Total Knee Application (TKA) | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| March 20, 2015 | K150410 | RESTORIS POROUS PARTIAL KNEE SYSTEM | HRY | Substantially Equivalent | Mako Surgical Corporation | accessdata.fda.gov |
| March 10, 2015 | K150307 | RESTORIS Multicompartmental Knee System | NPJ | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| January 26, 2015 | K142606 | Trident® Tritanium® PST® Acetabular Shells | LPH | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| November 13, 2014 | K141989 | MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM | OLO | Substantially Equivalent | Mako Surgical Corporation | accessdata.fda.gov |
| July 8, 2014 | K133811 | RESTORIS POROUS PARTIAL KNEE SYSTEM | NJD | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| December 10, 2013 | K133039 | RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM | NPJ | Substantially Equivalent | Mako Surgical Corporation | accessdata.fda.gov |
| June 6, 2012 | K121064 | MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM | OLO | Substantially Equivalent | Mako Surgical Corporation | accessdata.fda.gov |
| March 1, 2012 | K112507 | RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM | OLO | Substantially Equivalent | Mako Surgical Corporation | accessdata.fda.gov |
| February 24, 2010 | K093425 | MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| June 17, 2009 | K090763 | RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM | NPJ | Substantially Equivalent | Mako Surgical Corporation | accessdata.fda.gov |
| November 28, 2008 | K082172 | MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM | HSX | Substantially Equivalent | Mako Surgical Corporation | accessdata.fda.gov |
| December 12, 2007 | K073248 | MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM | HSX | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| February 23, 2006 | K060017 | MAKO SURGICAL UNICONDYLAR KNEE SYSTEM | HSX | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 8, 2022 | 90727 | Class II | Terminated | 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. | accessdata.fda.gov |
| October 23, 2020 | 86700 | Class II | Completed | 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 roboti | 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 | accessdata.fda.gov |
| July 9, 2020 | 86048 | Class II | Terminated | 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. | accessdata.fda.gov |
| April 25, 2019 | 82738 | Class II | Terminated | 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) | The bearings of the saw attachments were ungreased. | accessdata.fda.gov |
| July 24, 2018 | 80621 | Class II | Terminated | 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. | accessdata.fda.gov |
| May 10, 2018 | 80552 | Class II | Terminated | 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 sof | Out of tolerance. | accessdata.fda.gov |
| January 19, 2018 | 80016 | Class II | Terminated | Restoris MCK Onlay Insert Extractor. | Possible hinge pin disassociation from the Mako Onlay Insert Extractor. | accessdata.fda.gov |
| December 27, 2017 | 80762 | Class II | Terminated | 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 whi | Communication-connection error. | accessdata.fda.gov |
| December 1, 2017 | 79585 | Class II | Terminated | RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements. | Incorrect product and/or label. Sizing is labeled incorrectly. | accessdata.fda.gov |
| August 7, 2017 | 77950 | Class II | Terminated | 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 | Software discrepancy of not showing all the EE constants, when the screen is filled. | accessdata.fda.gov |
| June 7, 2017 | 77553 | Class II | Terminated | 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. | accessdata.fda.gov |
| December 22, 2016 | 76158 | Class II | Terminated | 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 | accessdata.fda.gov |
| September 29, 2016 | 76025 | Class II | Terminated | 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. | accessdata.fda.gov |
| February 23, 2016 | 73512 | Class II | Terminated | 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. | accessdata.fda.gov |
| January 15, 2016 | 73201 | Class II | Terminated | 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. | accessdata.fda.gov |
| November 25, 2015 | 73199 | Class II | Terminated | 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. | accessdata.fda.gov |
| July 16, 2015 | 72224 | Class II | Terminated | 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. | accessdata.fda.gov |
| January 22, 2015 | 70374 | Class II | Terminated | 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 | accessdata.fda.gov |
| October 7, 2014 | 69465 | Class II | Terminated | 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 Arth | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. | accessdata.fda.gov |
| April 30, 2014 | 73202 | Class II | Terminated | Robotic Arm Interactive Orthopedic System (RIO) | Revision of the field manual | accessdata.fda.gov |
| January 9, 2014 | 67444 | Class II | Terminated | Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) a | The product may be mislabeled and could result in the incorrect implant being used. | accessdata.fda.gov |
| September 12, 2012 | 63607 | Class II | Terminated | The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures duri | 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. | accessdata.fda.gov |
| January 20, 2011 | 58162 | Not yet classified | Terminated | Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL ARM, 201251 RIO GUIDANCE MODULE, 200294 RIO CAMERA STAND ASSEMBLY***PN 203999 SN ROB 125 2010-12 V 100/120/230 A 9.6/8.0/4.2 Hz 50/60 | 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. | accessdata.fda.gov |
| October 25, 2010 | 58464 | Not yet classified | Terminated | MAKO PN 204588 Camera 204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-01.*** Weight 86.2kg.***Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995, UL 60601-1: 2003, CAN/CSA-C22.2 N | 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 t | accessdata.fda.gov |
| July 17, 2009 | 53033 | Not yet classified | Terminated | 200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance Module, 200998 Cable Assembly, Hybrid, UI Panel Subcomponents for the 203000 RIO STANDARD SYSTEM Manufactured by: MAKO Surgical, Corp | 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. | accessdata.fda.gov |
| May 2, 2008 | 48598 | Not yet classified | Terminated | Tibial Array and Femoral Array. Model Number(s): 0150ARR00001 and 0150ARR00002. Manufactured by: MAKO Surgical, Corp. The devices are accessories used with MAKO's Tactile Guidance System (TGS). The Tactile Guidance Syste | The product in its current state may fail during use, which would cause the instrument to be in-accurate. | accessdata.fda.gov |
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Updated February 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.