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FDA 510(k)

EVOLUTION® Tibial Cones

K-Number: K233507 · 2024-01-18

ApplicantMicroport Orthopedics, Inc.
Decision Date2024-01-18
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOLUTION® Tibial Cones is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2024-01-18 under approval number K233507. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVOLUTION® Tibial Cones?

EVOLUTION® Tibial Cones is a medical device that received FDA 510(k) clearance on 2024-01-18. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K233507.

When was EVOLUTION® Tibial Cones approved by the FDA?

EVOLUTION® Tibial Cones received FDA 510(k) clearance on 2024-01-18, under approval number K233507.

What company makes EVOLUTION® Tibial Cones?

EVOLUTION® Tibial Cones is manufactured by Microport Orthopedics, Inc..

What is the FDA product code for EVOLUTION® Tibial Cones?

The FDA product code for EVOLUTION® Tibial Cones is MBH.

Other Devices by Microport Orthopedics, Inc.

K152631MPO Total Knee Systems MR Labeling K171181PROCOTYL® PRIME E-CLASS™ XLPE Liner K171389EVOLUTION Revision CCK System K170444PROCOTYL® PRIME Acetabular Cup System K170288BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell K162026EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions

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Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, Inc.

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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