510(k) K090763 ยท NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM
| Applicant | Mako Surgical Corporation, Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Jun 17, 2009 |
| Received | Mar 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090763
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2023 | Howmedica Osteonics Corp. stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure Open, Classified |
HSX | None listed |
| Apr 12, 2023 | Howmedica Osteonics Corp. stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure Open, Classified |
HSX | None listed |
| Jun 1, 2018 | Mako Surgical Corporation Restoris MCK Onlay Insert Extractor. Terminated |
NPJ | None listed |
| Jan 15, 2016 | Mako Surgical Corporation Restoris Multicompartmental Knee (MCK) System
RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO. Terminated |
NPJ | None listed |
| Mar 4, 2014 | Mako Surgical Corporation Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system Terminated |
NPJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.