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)

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 the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2024-01-18 under 510(k) 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. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K233507.

When did EVOLUTION® Tibial Cones receive FDA 510(k) clearance?

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

Who is the listed applicant for EVOLUTION® Tibial Cones?

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

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

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

Other records listing Microport 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.

K250444NEXUS® Hip StemK243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueK240046Ethylene Oxide Sterilization Supplier Change for MPO HipsK240452Ceramic Femoral HeadK240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseK231947EVOLUTION® Cement Keel

View all 29 devices →

Related Devices (Code: MBH)

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.

K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

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.

↑