Orthosoft Inc. (d/b/a) Zimmer CAS FDA Approvals

0 new drug approvals and 13 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Signature ONE System510(k)Jun 4, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jun 4, 2026
ROSA® Shoulder System510(k)May 21, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	May 21, 2026
Signature ONE System510(k)Feb 4, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Feb 4, 2026
Rosa® Knee System510(k)Nov 13, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 13, 2025
ROSA® Knee System510(k)Oct 18, 2024Neurology	Neurology	510(k)Substantially Equivalent (Special)	Oct 18, 2024
ROSA® Shoulder System510(k)Feb 21, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Feb 21, 2024
Signature ONE System510(k)Dec 12, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 12, 2023
OptiVu ROSA® MxR510(k)Jun 13, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 13, 2023
ROSA Hip System510(k)May 23, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	May 23, 2023
Rosa Knee System510(k)Feb 22, 2023Neurology	Neurology	510(k)Substantially Equivalent (Special)	Feb 22, 2023
OptiVu ROSA MxR510(k)Jul 29, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 29, 2022
ROSA® Knee System510(k)Apr 22, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 22, 2022
Signature ONE System510(k)Oct 12, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 12, 2021