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FDA 510(k)

Arthrex Virtual Implant Positioning (VIP) System

K-Number: K222007 · 2023-03-08

ApplicantArthrex, Inc.
Decision Date2023-03-08
Product CodeQHE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Virtual Implant Positioning (VIP) System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2023-03-08 under approval number K222007. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Virtual Implant Positioning (VIP) System?

Arthrex Virtual Implant Positioning (VIP) System is a medical device that received FDA 510(k) clearance on 2023-03-08. It is manufactured by Arthrex, Inc.. The 510(k) number is K222007.

When was Arthrex Virtual Implant Positioning (VIP) System approved by the FDA?

Arthrex Virtual Implant Positioning (VIP) System received FDA 510(k) clearance on 2023-03-08, under approval number K222007.

What company makes Arthrex Virtual Implant Positioning (VIP) System?

Arthrex Virtual Implant Positioning (VIP) System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Virtual Implant Positioning (VIP) System?

The FDA product code for Arthrex Virtual Implant Positioning (VIP) System is QHE.

Related Clinical Trials

NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT07612332 Non-Immersive Virtual Reality for Gait and Balance Training in Children With Cerebral Palsy NOT_YET_RECRUITING

Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

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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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