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FDA 510(k)

MPO Hip Instruments

K-Number: K213816 · 2022-01-05

ApplicantMicroport Orthopedics, Inc.
Decision Date2022-01-05
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MPO Hip Instruments 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 2022-01-05 under 510(k) number K213816. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MPO Hip Instruments?

MPO Hip Instruments is a medical device that received FDA 510(k) clearance on 2022-01-05. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K213816.

When did MPO Hip Instruments receive FDA 510(k) clearance?

MPO Hip Instruments received FDA 510(k) clearance on 2022-01-05, under 510(k) number K213816.

Who is the listed applicant for MPO Hip Instruments?

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 MPO Hip Instruments?

The FDA product code for MPO Hip Instruments is JDI.

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 InseK233507EVOLUTION® Tibial Cones

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Related Devices (Code: JDI)

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.

K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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