510(k) K121064 ยท OLO Orthopedic Stereotaxic Instrument
MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
| Applicant | Mako Surgical Corporation, Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Jun 6, 2012 |
| Received | Apr 6, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121064
| 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 | None listed |
| Aug 24, 2018 | Mako Surgical Corporation Stryker Mako Vizadisc Hip Procedure Tracking Kit Terminated |
OLO | None listed |
| 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 | None listed |
| Dec 22, 2016 | Mako Surgical Corporation MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery. Terminated |
OLO | None listed |
| 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 | None listed |
| Apr 18, 2016 | Mako Surgical Corporation Robotic Arm Interactive Orthopedic System (RIO) Terminated |
OLO | None listed |
| 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 | None listed |
| Nov 25, 2015 | Mako Surgical Corporation MAKOplasty Hip Array Kit Laminate 150230 Terminated |
OLO | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.