Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of StrykerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Mako Surgical with 42 510(k) clearances and 27 device recalls. The most recent is a 510(k) clearance dated Feb 25, 2026: Mako Total Knee Application.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 25, 2026 | Mako Total Knee ApplicationK260222 · OLO | 510(k) clearances |
| Apr 25, 2025 | Mako Total Knee Application (3.0); Hybrid Tip PointerK250608 · OLO | 510(k) clearances |
| Mar 5, 2025 | Mako Total Hip Application 5.0K243751 · OLO | 510(k) clearances |
| Nov 7, 2024 | Mako Shoulder Application (1.0)K242373 · OLO | 510(k) clearances |
| Jun 11, 2024 | Mako Total Knee ApplicationK241011 · OLO | 510(k) clearances |
| Aug 8, 2022 | Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.Class II · Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potenti | Device recalls |
| Jun 2, 2022 | Restoris Multi-Compartmental Knee SystemK220930 · HSX | 510(k) clearances |
| Apr 15, 2022 | Mako Total Knee ApplicationK220459 · OLO | 510(k) clearances |
| Oct 23, 2020 | Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0Class II · Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. Th | Device recalls |
| Jul 14, 2020 | Mako Total Knee ApplicationK193515 · OLO | 510(k) clearances |
| Jul 9, 2020 | Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167Class II · Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certa | Device recalls |
| Apr 25, 2019 | 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)Class II · The bearings of the saw attachments were ungreased. | Device recalls |
| Apr 25, 2019 | 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)Class II · The bearings of the saw attachments were ungreased. | Device recalls |
| Jul 24, 2018 | Stryker Mako Vizadisc Knee Procedure Tracking KitClass II · Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to | Device recalls |
| Jul 24, 2018 | Stryker Mako Vizadisc Hip Procedure Tracking KitClass II · Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to | Device recalls |
| Dec 27, 2017 | Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), foClass II · Communication-connection error. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
