Arthrex Virtual Implant Positioning System Software
510(k) K241097
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241097 | Date2 Oct 2024 | StatusActive |
Official records
- FDA 510(k) database K241097
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.