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FDA 510(k)

ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)

K-Number: K161668 · 2016-07-15

ApplicantConformis, Inc.
Decision Date2016-07-15
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) is a medical device manufactured by Conformis, Inc.. It received FDA 510(k) clearance on 2016-07-15 under approval number K161668. 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 ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)?

ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) is a medical device that received FDA 510(k) clearance on 2016-07-15. It is manufactured by Conformis, Inc.. The 510(k) number is K161668.

When was ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) approved by the FDA?

ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) received FDA 510(k) clearance on 2016-07-15, under approval number K161668.

What company makes ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)?

ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) is manufactured by Conformis, Inc..

What is the FDA product code for ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)?

The FDA product code for ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) is JWH.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING 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

Other Devices by Conformis, Inc.

K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) 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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