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FDA 510(k)

Mobio Total Knee System

K-Number: K202429 · 2020-10-23

ApplicantB-One Ortho, Corp.
Decision Date2020-10-23
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mobio Total Knee System is a medical device manufactured by B-One Ortho, Corp.. It received FDA 510(k) clearance on 2020-10-23 under approval number K202429. 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 Mobio Total Knee System?

Mobio Total Knee System is a medical device that received FDA 510(k) clearance on 2020-10-23. It is manufactured by B-One Ortho, Corp.. The 510(k) number is K202429.

When was Mobio Total Knee System approved by the FDA?

Mobio Total Knee System received FDA 510(k) clearance on 2020-10-23, under approval number K202429.

What company makes Mobio Total Knee System?

Mobio Total Knee System is manufactured by B-One Ortho, Corp..

What is the FDA product code for Mobio Total Knee System?

The FDA product code for Mobio Total Knee System is JWH.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by B-One Ortho, Corp.

K180446b-ONE Total Knee System K173380b-ONE® Total Hip System K182705Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups K183025MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System K210483MOBIO Total Knee System

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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.

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