SurgiTwin
by Twinsight 510(k)
Active
510(k) K250290
Overview
SurgiTwin is a personalized pre-operative planning tool designed for healthcare professionals. It provides automatic 3D templating based on patient clinical measurements and exports surgery targets such as cut values and implant sizes.
The device features AI-powered bone segmentation and labeling, offering reliable, accurate segmentation and clinical measurements. It is supplied as a software tool for use in clinical settings, with authorization under FDA 510(k) clearance (K250290) and product code LLZ.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250290 | Date29 Aug 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is SurgiTwin used for?
SurgiTwin is a personalized pre-operative planning tool designed for healthcare professionals. It provides automatic 3D templating based on patient clinical measurements and exports surgery targets such as cut values and implant sizes, using AI-powered bone segmentation and labeling to support surgical planning.
How is SurgiTwin supplied and what type of device is it?
SurgiTwin is supplied as a software tool for use in clinical settings. It is not a physical implant or hardware device but a digital planning application that processes patient data to generate surgical targets like cut values and implant sizes.
Is SurgiTwin a single-use or reusable device?
As a software tool, SurgiTwin is not subject to single-use or reuse limitations in the traditional sense. It can be used repeatedly for multiple patient cases as a digital planning aid, provided it operates within its intended functionality and system requirements.
What regulatory pathway was used for SurgiTwin’s authorization?
SurgiTwin received authorization through the FDA 510(k) clearance pathway, specifically under clearance K250290, with a decision date of August 29, 2025, and was found substantially equivalent to a predicate device.
What product code and advisory committee classification apply to SurgiTwin?
SurgiTwin is classified under product code LLZ and was reviewed by the Radiology advisory committee (RA), as indicated in its FDA 510(k) submission details. This classification reflects the device’s role in radiological imaging and pre-operative planning.