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FDA 510(k)

PS2 Knee System

K-Number: K160515 · 2016-12-19

ApplicantConsensus Orthopedics, Inc.
Decision Date2016-12-19
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PS2 Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Consensus Orthopedics, Inc.. It received FDA 510(k) clearance on 2016-12-19 under 510(k) number K160515. 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 PS2 Knee System?

PS2 Knee System is a medical device that received FDA 510(k) clearance on 2016-12-19. The listed applicant is Consensus Orthopedics, Inc.. The 510(k) number is K160515.

When did PS2 Knee System receive FDA 510(k) clearance?

PS2 Knee System received FDA 510(k) clearance on 2016-12-19, under 510(k) number K160515.

Who is the listed applicant for PS2 Knee System?

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

What is the FDA product code for PS2 Knee System?

The FDA product code for PS2 Knee System is JWH.

Other records listing Consensus Orthopedics, 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.

K170344Tahoe Uni Knee SystemK163167CKS Plus Knee System

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.

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 NVK252974EMPOWR KneeEncore 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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