FDA 510(k)

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

K-Number: K210809 · 2021-05-12

Decision Date2021-05-12

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) is the device name listed in this FDA 510(k) record. The listed applicant is Conformis, Inc.. It received FDA 510(k) clearance on 2021-05-12 under 510(k) 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. The listed applicant is Conformis, Inc.. The 510(k) number is K210809.

When did iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) receive FDA 510(k) clearance?

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

Who is the listed applicant for iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)?

The FDA 510(k) record lists Conformis, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02525601Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. UncementedACTIVE_NOT_RECRUITING NCT0283985014022 ATTUNE Cementless RP Clinical Performance EvaluationACTIVE_NOT_RECRUITING NCT04103502In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune PCR TKAWITHDRAWN NCT07533188Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty With Randomized Insert TypesRECRUITING

Other records listing Conformis, Inc. as applicant

K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS K231178ACTERA™ hip system K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert

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Related Devices (Code: JWH)

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC K261032NovoKnee (SteriKnee)NovoSource K253793Materialise TKA Guide SystemMaterialise NV

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.