Company · US
Mako Surgical Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
42510(k) clearances (1 in 12 months)
31recalls (0 in 12 months)
30recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 48 |
| HAW | Neurological Stereotaxic Instrument | 6 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 6 |
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 6 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | 2 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 |
| KQM | Camera, Surgical And Accessories | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 |
| NJD | Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 25, 2026 | K260222 | Mako Total Knee Application Mako Surgical Corp. | OLO |
| Apr 25, 2025 | K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer Mako Surgical Corp. | OLO |
| Mar 5, 2025 | K243751 | Mako Total Hip Application 5.0 Mako Surgical Corp. | OLO |
| Nov 7, 2024 | K242373 | Mako Shoulder Application (1.0) Mako Surgical Corp. | OLO |
| Jun 11, 2024 | K241011 | Mako Total Knee Application Mako Surgical Corp. | OLO |
| Jun 2, 2022 | K220930 | Restoris Multi-Compartmental Knee System Mako Surgical Corp. | HSX |
| Apr 15, 2022 | K220459 | Mako Total Knee Application Mako Surgical Corp. | OLO |
| Jul 14, 2020 | K193515 | Mako Total Knee Application Mako Surgical Corp. | OLO |
| Feb 2, 2020 | K193128 | Mako Total Hip Application Mako Surgical Corp. | OLO |
| Sep 24, 2019 | K191998 | Mako Total Hip Application, Mako Total Knee Application Mako Surgical Corp. | OLO |
| Nov 2, 2017 | K172301 | Mako Partial Knee Application Mako Surgical Corp. | OLO |
| Sep 21, 2017 | K172219 | Mako Total Knee Application Mako Surgical Corp. | OLO |
| May 24, 2017 | K170891 | Mako Partial Knee Application Mako Surgical Corp. | OLO |
| May 11, 2017 | K170584 | Mako Partial Knee Application Mako Surgical Corp. | OLO |
| May 11, 2017 | K170581 | Mako Total Knee Application Mako Surgical Corp. | OLO |
| Apr 18, 2017 | K170593 | Mako Total Hip Application Mako Surgical Corp. | OLO |
| Sep 16, 2015 | K142530 | Partial Knee Application (PKA) Mako Surgical Corporation | OLO |
| Aug 6, 2015 | K143752 | Total Knee Application (TKA) Mako Surgical Corp. | OLO |
| Mar 20, 2015 | K150410 | RESTORIS POROUS PARTIAL KNEE SYSTEM Mako Surgical Corporation | HRY |
| Mar 10, 2015 | K150307 | RESTORIS Multicompartmental Knee System Mako Surgical Corp. | NPJ |
| Feb 20, 2015 | K143635 | KINETIS Total Knee System Mako Surgical | JWH |
| Jan 26, 2015 | K142606 | Trident® Tritanium® PST® Acetabular Shells Mako Surgical Corp. | LPH |
| Nov 13, 2014 | K141989 | MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM Mako Surgical Corporation | OLO |
| Jul 8, 2014 | K133811 | RESTORIS POROUS PARTIAL KNEE SYSTEM Mako Surgical Corp. | NJD |
| Dec 10, 2013 | K133039 | RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM Mako Surgical Corporation | NPJ |
| Jun 6, 2012 | K121064 | MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM Mako Surgical Corporation | OLO |
| Mar 1, 2012 | K112507 | RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM Mako Surgical Corporation | OLO |
| Feb 24, 2010 | K093425 | MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA Mako Surgical Corp. | OLO |
| Sep 28, 2009 | K091998 | ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP Mako Surgical Corp. | OLO |
| Jun 19, 2009 | K083644 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP Mako Surgical Corp. | OLO |
| Jun 17, 2009 | K090763 | RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM Mako Surgical Corporation | NPJ |
| Nov 28, 2008 | K082172 | MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM Mako Surgical Corporation | HSX |
| Nov 25, 2008 | K081867 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0 Mako Surgical Corp. | HAW |
| Oct 22, 2008 | K082088 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II Mako Surgical Corp. | KRR |
| Oct 15, 2008 | K082081 | MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III Mako Surgical Corp. | HSX |
| Jun 20, 2008 | K080368 | MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II Mako Surgical Corp. | HSX |
| May 16, 2008 | K080029 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM Mako Surgical Corp. | KRR |
| Jan 24, 2008 | K072806 | MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) Mako Surgical Corp. | HAW |
| Dec 12, 2007 | K073248 | MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM Mako Surgical Corp. | HSX |
| Feb 23, 2006 | K060017 | MAKO SURGICAL UNICONDYLAR KNEE SYSTEM Mako Surgical Corp. | HSX |
| Nov 18, 2005 | K052851 | VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS) Mako Surgical Corp. | HAW |
| May 17, 2005 | K050973 | MODIFICATION TO: VOYAGER LINUX Mako Surgical Corp. | HAW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2022 | Mako Surgical Corporation Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System. Terminated |
OLO | K121064 |
| Nov 19, 2020 | Mako Surgical Corporation 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 dist Completed |
OLO | K142350 |
| Jul 31, 2020 | Mako Surgical Corporation Mako Hip End Effector, Variable Angle
Catalog Number: 206967
GTIN:00848486022167 Terminated |
OLO | K141989 |
| Apr 25, 2019 | Mako Surgical Corporation 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0) Terminated |
OLO | K143752 |
| Apr 25, 2019 | Mako Surgical Corporation 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) Terminated |
OLO | K143752 |
| Aug 24, 2018 | Mako Surgical Corporation Stryker Mako Vizadisc Hip Procedure Tracking Kit Terminated |
OLO | K121064 |
| Aug 24, 2018 | Mako Surgical Corporation Stryker Mako Vizadisc Knee Procedure Tracking Kit Terminated |
OLO | K112507 |
| Jun 1, 2018 | Mako Surgical Corporation Restoris MCK Onlay Insert Extractor. Terminated |
NPJ | K090763 |
| May 10, 2018 | Mako Surgical Corporation 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 sur Terminated |
OLO | K170891 |
| Dec 27, 2017 | Mako Surgical Corporation 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 kn Terminated |
OLO | K170581 K170584 +2 |
| Dec 1, 2017 | Mako Surgical Corporation RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements. Terminated |
OLO | K170584 K170891 |
| Aug 7, 2017 | Mako Surgical Corporation 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 an Terminated |
OLO | K121064 K141989 |
| Aug 7, 2017 | Mako Surgical Corporation 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 o Terminated |
OLO | K112507 |
| Jun 7, 2017 | Mako Surgical Corporation MAKO RIO Standard System, internal cPCI Card CageP/N: 201337.
Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures. Terminated |
OLO | K112507 |
| Dec 22, 2016 | Mako Surgical Corporation MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery. Terminated |
OLO | K121064 K141989 |
| Sep 29, 2016 | Mako Surgical Corporation 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. Terminated |
OLO | K121064 |
| Apr 18, 2016 | Mako Surgical Corporation Robotic Arm Interactive Orthopedic System (RIO) Terminated |
OLO | K112507 K121064 |
| Feb 23, 2016 | Mako Surgical Corporation 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. Terminated |
OLO | K121064 |
| Jan 15, 2016 | Mako Surgical Corporation Restoris Multicompartmental Knee (MCK) System
RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO. Terminated |
NPJ | K090763 |
| Nov 25, 2015 | Mako Surgical Corporation MAKOplasty Hip Array Kit Laminate 150230 Terminated |
OLO | K121064 |
| Nov 5, 2015 | Mako Surgical Corporation 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 replacem Terminated |
OLO | K112507 K121064 |
| Feb 19, 2015 | Mako Surgical Corporation 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. Terminated |
OLO | K112507 |
| Dec 18, 2014 | Mako Surgical Corporation 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 co Terminated |
OLO | K121064 |
| Dec 18, 2014 | Mako Surgical Corporation 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 Terminated |
OLO | K121064 |
| Dec 18, 2014 | Mako Surgical Corporation 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 d Terminated |
OLO | K121064 |
| Mar 4, 2014 | Mako Surgical Corporation 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 Terminated |
NPJ | K090763 |
| Nov 19, 2012 | Mako Surgical Corporation 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 anat Terminated |
OLO | K081867 |
| Nov 1, 2011 | Mako Surgical Corporation 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 Terminated |
OLO | K093425 |
| May 20, 2011 | Mako Surgical Corporation 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: Terminated |
KQM | None listed |
| Oct 19, 2009 | Mako Surgical Corporation 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 Terminated |
HAW | K081867 |
| Feb 11, 2009 | Mako Surgical Corporation 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 Terminated |
HAW | K072806 |