Weston, FL, US · 9 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | 8 | 2026-02-25 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | 1 | 2022-06-02 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-08-08 | Class II | Terminated | Z-1735-2022 | Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery S… | — | 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… |
| 2020-10-23 | Class II | Completed | Z-0472-2021 | Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 an… | — | Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the dist… |
| 2020-07-09 | Class II | Terminated | 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. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-02-25 | K260222 | Mako Total Knee Application | OLO | Class II | Neurology |
| 2025-04-25 | K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer | OLO | Class II | Neurology |
| 2025-03-05 | K243751 | Mako Total Hip Application 5.0 | OLO | Class II | Neurology |
| 2024-11-07 | K242373 | Mako Shoulder Application (1.0) | OLO | Class II | Neurology |
| 2024-06-11 | K241011 | Mako Total Knee Application | OLO | Class II | Neurology |
| 2022-06-02 | K220930 | Restoris Multi-Compartmental Knee System | HSX | Class II | Orthopedic |
| 2022-04-15 | K220459 | Mako Total Knee Application | OLO | Class II | Neurology |
| 2020-07-14 | K193515 | Mako Total Knee Application | OLO | Class II | Neurology |
| 2020-02-02 | K193128 | Mako Total Hip Application | OLO | Class II | Neurology |