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FDA 510(k)

ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)

K-Number: K161366 · 2016-06-14

ApplicantConformis, Inc.
Decision Date2016-06-14
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) is a medical device manufactured by Conformis, Inc.. It received FDA 510(k) clearance on 2016-06-14 under approval number K161366. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)?

ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) is a medical device that received FDA 510(k) clearance on 2016-06-14. It is manufactured by Conformis, Inc.. The 510(k) number is K161366.

When was ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) approved by the FDA?

ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) received FDA 510(k) clearance on 2016-06-14, under approval number K161366.

What company makes ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)?

ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) is manufactured by Conformis, Inc..

What is the FDA product code for ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)?

The FDA product code for ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) is JWH.

Related Clinical Trials

NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT07601269 Replacement of the Native Mitral Valve Using the ReValve System RECRUITING NCT06414265 Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation RECRUITING NCT06608823 ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ RECRUITING NCT03242642 Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. RECRUITING NCT07276711 CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material RECRUITING

Other Devices by Conformis, Inc.

K161668ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) K153721iTotal Cruciate Retaining (CR) Knee Replacement System K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System K153217ConforMIS iTotal Posterior Stabilized Knee Replacement System K170226iTotal Family Reusable Instrument Tray K162719iTotal® Hip Replacement System

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Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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