mediCAD 4.0
by mediCAD HECTEC GMBH United States EUDAMED510(k)
510(k) K170702
Product code LLZ
Overview
mediCAD 4.0 is a Computer-Assisted Surgery System for pre-operative planning of joint replacement surgeries, designed to facilitate digital simulation and optimization of orthopaedic procedures. It integrates radiographic imaging and anatomical data to generate precise surgical templates and implant positioning plans, enhancing surgical precision and reducing operative risks.
This software is supplied as a standalone application for use in radiology departments and orthopaedic clinics, requiring no additional hardware beyond standard imaging systems. It is intended for single-use per surgical case, with no sterility requirements, and operates within standard MRI safety guidelines (non-MRI compatible). The system is authorised under FDA 510(k) clearance (K170702) and EU MDR compliance, with no third-party involvement in its regulatory submission.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK170702 | Date7 Sep 2018 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
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
Other devices from mediCAD HECTEC GMBH
Questions
What types of joint replacement surgeries can the mediCAD 4.0 system help plan for, and how does it integrate with existing imaging systems?
The mediCAD 4.0 is designed specifically for pre-operative planning of joint replacement surgeries, though the exact surgical types are not detailed beyond this. It integrates with standard radiographic imaging systems to combine anatomical data and imaging for precise surgical planning. Since it requires no additional hardware beyond standard imaging systems, it can be used with existing MRI or X-ray equipment in radiology departments or orthopaedic clinics. The system generates surgical templates and implant positioning plans to enhance precision and reduce operative risks.
Is the mediCAD 4.0 software reusable for multiple surgical cases, or is it intended for single-use per procedure?
The mediCAD 4.0 is explicitly stated as intended for single-use per surgical case. This means each new surgical planning session would require a fresh installation or activation of the software, though it does not require sterilization since it is a non-sterile digital application. The software itself is not a physical device subject to reuse constraints, but its intended use aligns with a one-to-one relationship with a surgical case.
How does the mediCAD 4.0 system ensure safety when used in clinical settings, particularly in relation to MRI environments?
The mediCAD 4.0 system is explicitly labeled as non-MRI compatible, meaning it should not be used within an MRI environment. Its safety is ensured through adherence to standard MRI safety guidelines, which likely means it avoids materials or configurations that could interfere with MRI operations. Since it is a standalone software application, its safety primarily relies on proper usage in approved clinical settings like radiology departments or orthopaedic clinics, where MRI compatibility is not required.
What regulatory pathways has mediCAD 4.0 followed, and who was responsible for the FDA submission?
The mediCAD 4.0 system has undergone regulatory review through the FDA’s 510(k) clearance process, specifically under the traditional pathway with a decision code of SESE (Substantially Equivalent). The submission was filed by mediCAD HECTEC GmbH, with no third-party involvement noted in the regulatory documentation. It is also compliant with EU MDR requirements, ensuring its authorization spans both the U.S. and European markets.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K170702
- EUDAMED