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Conformis, Inc. FDA Approvals

0 new drug approvals and 15 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
Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts510(k)Sep 8, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Sep 8, 2023
Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System510(k)Jul 21, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 21, 2023
iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System510(k)Jul 17, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 17, 2023
Identity Imprint CR KRS and Identity Imprint PS KRS510(k)May 26, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	May 26, 2023
ACTERA hip system510(k)May 23, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	May 23, 2023
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert510(k)Apr 27, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Apr 27, 2023
Actera hip system510(k)Aug 4, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 4, 2022
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)510(k)Jul 26, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 26, 2022
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)510(k)May 10, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	May 10, 2022
Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System510(k)Nov 10, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Nov 10, 2021
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)510(k)Sep 23, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 23, 2021
iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS)510(k)May 12, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 12, 2021
Identity Imprint Knee Replacement System510(k)May 6, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 6, 2021
Triathlon AS-1510(k)Apr 19, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 19, 2021
iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System510(k)Feb 17, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Feb 17, 2021

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