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

FDA 510(k)

PROLIXUS TOTAL KNEE SYSTEM

K-Number: K170534 · 2017-11-09

ApplicantOtis Biotech Co., Ltd.
Decision Date2017-11-09
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROLIXUS TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Otis Biotech Co., Ltd.. It received FDA 510(k) clearance on 2017-11-09 under 510(k) number K170534. 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 PROLIXUS TOTAL KNEE SYSTEM?

PROLIXUS TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2017-11-09. The listed applicant is Otis Biotech Co., Ltd.. The 510(k) number is K170534.

When did PROLIXUS TOTAL KNEE SYSTEM receive FDA 510(k) clearance?

PROLIXUS TOTAL KNEE SYSTEM received FDA 510(k) clearance on 2017-11-09, under 510(k) number K170534.

Who is the listed applicant for PROLIXUS TOTAL KNEE SYSTEM?

The FDA 510(k) record lists Otis Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROLIXUS TOTAL KNEE SYSTEM?

The FDA product code for PROLIXUS TOTAL KNEE SYSTEM is JWH.

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.

↑