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FDA 510(k)

PROCOTYL® PRIME Acetabular Cup System

K-Number: K170444 · 2017-06-26

ApplicantMicroport Orthopedics, Inc.
Decision Date2017-06-26
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROCOTYL® PRIME Acetabular Cup System is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2017-06-26 under approval number K170444. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROCOTYL® PRIME Acetabular Cup System?

PROCOTYL® PRIME Acetabular Cup System is a medical device that received FDA 510(k) clearance on 2017-06-26. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K170444.

When was PROCOTYL® PRIME Acetabular Cup System approved by the FDA?

PROCOTYL® PRIME Acetabular Cup System received FDA 510(k) clearance on 2017-06-26, under approval number K170444.

What company makes PROCOTYL® PRIME Acetabular Cup System?

PROCOTYL® PRIME Acetabular Cup System is manufactured by Microport Orthopedics, Inc..

What is the FDA product code for PROCOTYL® PRIME Acetabular Cup System?

The FDA product code for PROCOTYL® PRIME Acetabular Cup System is LPH.

Related Clinical Trials

NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT03735667 ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement ACTIVE_NOT_RECRUITING NCT05608408 PRIME: PReservIng Memory in Epilepsy RECRUITING NCT06751355 Precision Imaging to Evaluate Kaposi Sarcoma (PRIME-KS): A Device Feasibility Trial RECRUITING

Other Devices by Microport Orthopedics, Inc.

K152631MPO Total Knee Systems MR Labeling K171181PROCOTYL® PRIME E-CLASS™ XLPE Liner K171389EVOLUTION Revision CCK 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 K182125EVOLUTION Stemmed CS Femur

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Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, 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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