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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 the device name listed in this FDA 510(k) record. The listed applicant is Conformis, Inc.. It received FDA 510(k) clearance on 2016-07-15 under 510(k) 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. The listed applicant is Conformis, Inc.. The 510(k) number is K161668.

When did ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) receive FDA 510(k) clearance?

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

Who is the listed applicant for ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)?

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 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

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.

NCT0283985014022 ATTUNE Cementless RP Clinical Performance EvaluationACTIVE_NOT_RECRUITINGNCT03391323Medacta GMK Sphere® vs. Medacta GMK PS Post-Market Outcomes StudyCOMPLETEDNCT05391828Persona MC vs PS RCT With ROSARECRUITINGNCT07286513Persona SoluTion PPS Femur PMCFENROLLING_BY_INVITATION

Other records listing Conformis, Inc. as applicant

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.

K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) InsertsK223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement SystemK230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemK231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSK231178ACTERA™ hip systemK230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert

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Related Devices (Code: JWH)

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.

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 UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise 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.

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