Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)

K-Number: K210809 · 2021-05-12

ApplicantConformis, Inc.
Decision Date2021-05-12
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) is a medical device manufactured by Conformis, Inc.. It received FDA 510(k) clearance on 2021-05-12 under approval number K210809. 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 iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)?

iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) is a medical device that received FDA 510(k) clearance on 2021-05-12. It is manufactured by Conformis, Inc.. The 510(k) number is K210809.

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

iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) received FDA 510(k) clearance on 2021-05-12, under approval number K210809.

What company makes iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)?

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

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

The FDA product code for iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (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) 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

View all 30 devices →

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.

↑