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Arthrex Virtual Implant Positioning System Software

by Arthrex, Inc.

510(k) K241097

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK241097 Date2 Oct 2024ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Arthrex Virtual Implant Positioning (VIP) System Software
510(k) Number
FDA product code
QHE
Device class
Class II
Regulation
21 CFR Part 888.3660
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Arthrex Virtual Implant Positioning System Software is a shoulder arthroplasty implantation system designed for preoperative planning. It facilitates implant selection and surgical planning for anatomic and reverse total shoulder arthroplasty procedures.

This software is authorized under FDA 510K clearance. It is used in conjunction with patient-specific surgical instrumentation to support surgical transfer and planning.

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