Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Zimmer BiometLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Orthosoft with 35 510(k) clearances, 7 device recalls and 1 warning letter. The most recent is a 510(k) clearance dated Feb 21, 2024: ROSA® Shoulder System.
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 21, 2024 | ROSA® Shoulder SystemK233199 · OLO | 510(k) clearances |
| Nov 16, 2023 | ROSA Partial Knee SystemK232533 · OLO | 510(k) clearances |
| Jun 13, 2023 | OptiVu™ ROSA® MxRK230567 · SBF | 510(k) clearances |
| May 23, 2023 | ROSA Hip SystemK231162 · LLZ | 510(k) clearances |
| Mar 29, 2023 | ROSA® Knee SystemK230243 · OLO | 510(k) clearances |
| Feb 22, 2023 | Rosa Knee SystemK230180 · OLO | 510(k) clearances |
| Oct 4, 2022 | ROSA® Knee SystemK221928 · OLO | 510(k) clearances |
| Jul 29, 2022 | OptiVu ROSA MxRK220733 · SBF | 510(k) clearances |
| Jan 7, 2022 | NavitrackER Kit A: Knee, Model Number 20-8000-000-07,Class II · The product was released for distribution without passing sterilization results, which could potentially lead to insuffi | Device recalls |
| Aug 2, 2019 | Warning letter: Medical DevicesCDRH | Warning letters |
| Feb 20, 2017 | SmartTools Knee System Orthopedic Stereotaxic InstrumentClass II · There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufa | Device recalls |
| Oct 6, 2011 | Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of totClass II · Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-U | Device recalls |
| Jun 9, 2009 | NDI P7 Position Sensor, Stereotaxic InstrumentClass II · Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoi | Device recalls |
| Oct 28, 2008 | Navitrack System - OS Knee Universal, Stereotaxic instrumentClass II · Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2. | Device recalls |
| Jun 20, 2008 | Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic InstrumentClass III · ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software ano | Device recalls |
| Jun 4, 2008 | Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based Class II · Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of the workst | 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
