Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132290 FDA 510(k)
- FDA Product Code
- PBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Surgicase Orthopaedics System is classified as an Orthopaedic Surgical Planning and Instrument Guide. It is a software-integrated system designed to assist in pre-operative planning and intra-operative guidance for orthopaedic procedures, including non-acute osteotomies of the upper extremity and around the knee. The system generates patient-specific surgical guides to improve precision in bone cuts and implant positioning.
The system is supplied as a combination of software and reusable mechanical guides, intended for use in orthopaedic surgical settings. It requires pre-operative imaging data for guide fabrication and is regulated under FDA 510(k) clearance (K132290) as a Class II device. No sterility or single-use designation is specified, and MRI safety is not addressed in the provided data.
Frequently asked questions
What types of orthopaedic procedures is the Surgicase Orthopaedics System designed to assist with during surgery?
The Surgicase Orthopaedics System is specifically designed to assist in pre-operative planning and intra-operative guidance for orthopaedic procedures involving non-acute osteotomies of the upper extremity and around the knee. It generates patient-specific surgical guides to enhance precision in bone cuts and implant positioning, ensuring tailored support for these targeted procedures.
Is the Surgicase Orthopaedics System intended for single-use or reusable applications, and what does this mean for my workflow?
The system is supplied as a combination of software and reusable mechanical guides, meaning the physical guides can be used across multiple procedures after proper cleaning and maintenance. This design allows for cost efficiency and flexibility in workflow, as the guides do not need to be discarded after a single use. However, the reusable nature requires adherence to sterile protocols during each surgical application.
How does the Surgicase Orthopaedics System integrate with pre-operative planning, and what data is required to use it?
The system relies on pre-operative imaging data (such as CT or MRI scans) to create patient-specific surgical guides. This data is uploaded into the software, which then generates custom guides tailored to the patient’s anatomy. The imaging ensures the guides align precisely with the planned osteotomy or implant placement, improving surgical accuracy.
What regulatory pathway has the Surgicase Orthopaedics System followed, and what does this mean for its use in clinical settings?
The system has undergone FDA 510(k) clearance (K132290) as a Class II device, classified under Orthopaedic Surgical Planning and Instrument Guides. This means it has been evaluated for substantial equivalence to a predicate device and meets FDA safety and performance requirements. Clinically, this clearance indicates it is authorized for use in orthopaedic settings as described in its intended purpose.
Are there multiple models or sizes of the Surgicase Orthopaedics System, and how do I determine which one is appropriate for my patient?
The system includes multiple guide variants (as indicated by the diverse FEI numbers in the data), each likely designed to accommodate different anatomical regions or procedure types (e.g., upper extremity vs. knee osteotomies). The appropriate model is determined by the pre-operative imaging data and the specific surgical plan, as the software selects or generates the correct guide based on the patient’s anatomy and the intended procedure.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides ..., surgicase orthopaedics system surgicase connect surgicase guides, K163156 - SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides ..., Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132290 | Class II | Active |
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Manufacturer
- Manufacturer
- Materialise NV
Sources (1)
- FDA 510(k) K132290 24 fields · synced Sep 19, 2026