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FDA 510(k)

OVOMotion Reverse Shoulder Arthroplasty System

K-Number: K203375 · 2021-06-24

ApplicantArthrosurface, Inc.
Decision Date2021-06-24
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OVOMotion Reverse Shoulder Arthroplasty System is a medical device manufactured by Arthrosurface, Inc.. It received FDA 510(k) clearance on 2021-06-24 under approval number K203375. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVOMotion Reverse Shoulder Arthroplasty System?

OVOMotion Reverse Shoulder Arthroplasty System is a medical device that received FDA 510(k) clearance on 2021-06-24. It is manufactured by Arthrosurface, Inc.. The 510(k) number is K203375.

When was OVOMotion Reverse Shoulder Arthroplasty System approved by the FDA?

OVOMotion Reverse Shoulder Arthroplasty System received FDA 510(k) clearance on 2021-06-24, under approval number K203375.

What company makes OVOMotion Reverse Shoulder Arthroplasty System?

OVOMotion Reverse Shoulder Arthroplasty System is manufactured by Arthrosurface, Inc..

What is the FDA product code for OVOMotion Reverse Shoulder Arthroplasty System?

The FDA product code for OVOMotion Reverse Shoulder Arthroplasty System is PHX.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT05735119 Embody Post-Market Clinical Follow-Up Study ACTIVE_NOT_RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT03073941 A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Arthrosurface, Inc.

K161539Arthrosurface Bone Screws K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty System K172383Arthrosurface Bone Screws K170440KISSloc Suture System K170350ToeMATE® Hammertoe Correction System K162391AlignMATE™ Lapidus Arthrodesis System

View all 11 devices →

Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, 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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