Mako Surgical Corporation
Mako Surgical Corporation holds FDA 510(k) medical device clearances, first cleared 2008, most recent 2015, with 27 FDA device recalls on record.
Top product codes for Mako Surgical Corporation
FDA recalls by Mako Surgical Corporation
10 most recent of 27- Z-1735-2022 — Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
- Z-0472-2021 — 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 robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).
- Z-2745-2020 — Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
- Z-1824-2019 — 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
- Z-1823-2019 — 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
- Z-2925-2018 — Stryker Mako Vizadisc Hip Procedure Tracking Kit
- Z-2924-2018 — Stryker Mako Vizadisc Knee Procedure Tracking Kit
- Z-2794-2018 — 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 software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.
- Z-2051-2018 — Restoris MCK Onlay Insert Extractor.
- Z-3182-2018 — 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 which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include Unicondylar knee replacement and/or patellofemoral knee replacement.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Mako Surgical Corporation
- K142530 — Partial Knee Application (PKA)
- K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM
- K141989 — MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM
- K133039 — RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
- K121064 — MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
- K112507 — RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
- K090763 — RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM
- K082172 — MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.