Mako
Integrated Cutting System Sagittal Blade - Standard
5manufacturers in China registered for this device type
21catalogue numbers in this listing
23510(k) clearances naming this product code
25recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Mako Surgical Corp., United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K220459 |
| Record published | 2026-01-14 |
| Record revised | 2021-01-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 700000625059 | In distribution | |
| 116171 | In distribution | |
| 212252 | In distribution | |
| 1025-200-075 | In distribution | |
| 116170 | Size: Standard | In distribution |
| TKA 1.0.3 + THA 3.1.4 + PKA 3.0.4 | In distribution | |
| 213951 | In distribution | |
| TKA 2.0.1+TKA 1.0.3+THA 4.1.1+PKA 3.0.4 | In distribution | |
| TKA 1.0.3+ THA 4.1.1 + PKA 3.0.4 | In distribution | |
| TKA 2.0.1+TKA 1.0.3+THA 4.0.2+PKA 3.0.4 | In distribution | |
| 190671 | In distribution | |
| 210490 | In distribution | |
| Shoulder 1.0+TKA 2.0.1+TKA 1.0.3+THA 4.1 | In distribution | |
| 110133 | Size: Standard | In distribution |
| 1.0 | In distribution | |
| 1.0 | In distribution | |
| 1020-200-075 | In distribution | |
| TKA 1.0.3 + THA 4.0.2 + PKA 3.0.4 | In distribution | |
| 290651 | In distribution | |
| 110134 | In distribution | |
| 110135 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valence Robotic Navigation System | Alphatec Spine, Inc. | 813 |
| Olympic | Astura Medical | 684 |
| Excelsius GPS | Globus Medical, Inc. | 383 |
| Orthopedic Stereotaxic Instrument | Medtronic Navigation, Inc. | 356 |
| Masada | Astura Medical | 335 |
| Excelsiusgps | Globus Medical, Inc. | 297 |
| Invictus | Alphatec Spine, Inc. | 235 |
| OrthAlign Plus | OrthAlign, Inc. | 210 |
| Arvis ® | Kico Knee Innovation Company | 174 |
| OMNIBotics | Omni Life Science, Inc. | 150 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 137 |
| Navigation Instruments | VB Spine LLC | 135 |
Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260222 | 2026-02-25 |
| K250608 | 2025-04-25 |
| K243751 | 2025-03-05 |
| K242373 | 2024-11-07 |
| K241011 | 2024-06-11 |
| K220459 | 2022-04-15 |
| K193515 | 2020-07-14 |
| K193128 | 2020-02-02 |
| K191998 | 2019-09-24 |
| K172301 | 2017-11-02 |
| K172219 | 2017-09-21 |
| K170891 | 2017-05-24 |
| K170581 | 2017-05-11 |
| K170584 | 2017-05-11 |
| K170593 | 2017-04-18 |
| K142530 | 2015-09-16 |
| K143752 | 2015-08-06 |
| K141989 | 2014-11-13 |
| K121064 | 2012-06-06 |
| K112507 | 2012-03-01 |
| K093425 | 2010-02-24 |
| K091998 | 2009-09-28 |
| K083644 | 2009-06-19 |
Recalls Naming This Product
10 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Howmedica Osteonics Corp | 510(k) number | 2026-02-02 | Class II | Under Investigation by firm | A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachme | 1098 units | |
| Stryker Orthopaedics | 510(k) number | 2024-04-15 | Class II | Device Design | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not perfo | 334 units | |
| Stryker Orthopaedics | 510(k) number | 2024-04-15 | Class II | Device Design | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not perfo | 1,635 units | |
| Stryker Orthopaedics | 510(k) number | 2024-04-15 | Class II | Device Design | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not perfo | 20 units | |
| Stryker Orthopaedics | 510(k) number | 2024-04-15 | Class II | Device Design | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not perfo | 68 units | |
| Stryker Orthopaedics | 510(k) number | 2024-04-15 | Class II | Device Design | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not perfo | 40 units | |
| Stryker Orthopaedics | 510(k) number | 2024-04-15 | Class II | Device Design | Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not perfo | 0 | |
| Mako Surgical Corp. | 510(k) number | 2020-07-09 | Class II | Under Investigation by firm | Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures. | 12 units | 2023-06-16 |
| Mako Surgical Corp. | 510(k) number | 2017-08-07 | Class II | Software design | Software discrepancy of not showing all the EE constants, when the screen is filled. | 291 (US) and 66 (OUS) | 2019-08-06 |
| Mako Surgical Corp. | 510(k) number | 2016-12-22 | Class II | Labeling design | Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides | 777 | 2019-08-06 |
Recalls
21 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-08-08 | Class II | Under Investigation by firm | 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. | 2 | 2026-05-22 |
| 2020-10-23 | Class II | Under Investigation by firm | 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 pr | 367 units | |
| 2019-04-25 | Class II | Under Investigation by firm | The bearings of the saw attachments were ungreased. | 7 | 2021-04-22 |
| 2019-04-25 | Class II | Under Investigation by firm | The bearings of the saw attachments were ungreased. | 39 | 2021-04-22 |
| 2018-07-24 | Class II | Under Investigation by firm | 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. | 19,906 total devices | 2022-10-11 |
| 2018-07-24 | Class II | Under Investigation by firm | 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. | 19,906 total devices | 2022-10-11 |
| 2018-05-10 | Class II | Nonconforming Material/Component | Out of tolerance. | 10,606 | 2021-01-17 |
| 2017-12-27 | Class II | Nonconforming Material/Component | Communication-connection error. | 736 (US) and 174 (OUS) | 2020-12-14 |
| 2017-12-01 | Class II | Error in labeling | Incorrect product and/or label. Sizing is labeled incorrectly. | 126 | 2020-12-14 |
| 2017-08-07 | Class II | Software design | Software discrepancy of not showing all the EE constants, when the screen is filled. | 349 (US) and 78 (OUS) | 2019-08-06 |
| 2017-06-07 | Class II | Employee error | An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection. | 20 | 2020-06-16 |
| 2016-09-29 | Class II | Component change control | Failure of the Offset Cup Reamer Handle not engaging its mating components. | 595 units | 2019-08-06 |
| 2016-02-23 | Class II | Nonconforming Material/Component | Potential disassociation of the orientation pin. | 96 | 2016-12-14 |
| 2015-11-25 | Class II | Component change control | 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. | 10 units. | 2016-08-25 |
| 2015-07-16 | Class II | Device Design | The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector. | 1,322 units | 2016-12-14 |
| 2015-01-22 | Class II | Device Design | 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 | 228 units | 2016-12-14 |
| 2014-10-07 | Class II | Device Design | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. | Total 404 | 2016-10-03 |
| 2014-10-07 | Class II | Device Design | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. | Total 404 | 2016-10-03 |
| 2014-10-07 | Class II | Device Design | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. | Total 404 | 2016-10-03 |
| 2014-04-30 | Class II | Process control | Revision of the field manual | 249 | 2019-07-24 |
| 2012-09-12 | Class II | Software design | 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 th | 137 devices | 2013-05-22 |
| 2011-01-20 | Not classified | Software change control | 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. | 70 | 2011-12-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.