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FDA 510(k)

OVOMotion Shoulder Arthroplasty System

K-Number: K173964 · 2018-04-18

ApplicantArthrosurface, Inc.
Decision Date2018-04-18
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OVOMotion Shoulder Arthroplasty System is a medical device manufactured by Arthrosurface, Inc.. It received FDA 510(k) clearance on 2018-04-18 under approval number K173964. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVOMotion Shoulder Arthroplasty System?

OVOMotion Shoulder Arthroplasty System is a medical device that received FDA 510(k) clearance on 2018-04-18. It is manufactured by Arthrosurface, Inc.. The 510(k) number is K173964.

When was OVOMotion Shoulder Arthroplasty System approved by the FDA?

OVOMotion Shoulder Arthroplasty System received FDA 510(k) clearance on 2018-04-18, under approval number K173964.

What company makes OVOMotion Shoulder Arthroplasty System?

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

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

The FDA product code for OVOMotion Shoulder Arthroplasty System is HSD.

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 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 NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population 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: HSD)

K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc. K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH K151527Arthrex Univers Revers CA Heads and AdaptersArthrex, Inc. K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC K221232Univers Revers Humeral Cup ImplantArthrex, 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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