QUANTUM Patient Specific Instrumentation (PSI) System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by In2Bones SAS
Identifiers
- 510(k) Number
- K230313 FDA 510(k)
- FDA Product Code
- HSN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3110 FDA 510(k)
- Regulation Number
- 888.3110 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Quantum Patient-Specific Instrumentation System is a patient-specific orthopedic instrumentation device designed for use in ankle arthroplasty procedures. It is classified as a semi-constrained, cemented ankle prosthesis and is intended to assist in precise surgical alignment and component placement during total ankle replacement surgeries.
This system is supplied as a reusable medical device and is intended for use in sterile surgical environments. It is not MRI-compatible and must be handled according to standard orthopedic instrumentation protocols. The system is authorised under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), with registration numbers and FEI numbers listed for compliance tracking. Storage and handling follow standard orthopedic device guidelines to ensure sterility and functionality.
Frequently asked questions
What types of surgical procedures is the Quantum Patient-Specific Instrumentation (PSI) System designed for?
The Quantum PSI System is specifically designed to assist in ankle arthroplasty procedures, particularly for total ankle replacement surgeries. It aids in achieving precise surgical alignment and component placement of semi-constrained, cemented ankle prostheses.
Is the Quantum PSI System reusable or single-use, and how should it be handled in the operating room?
The Quantum PSI System is a reusable medical device, intended for use in sterile surgical environments. It must be handled according to standard orthopedic instrumentation protocols to maintain sterility and functionality.
What regulatory pathways has the Quantum PSI System undergone, and how can I verify its compliance?
The Quantum PSI System has been authorized under both the FDA 510(k) clearance process and the EU Medical Device Regulation (MDR). Compliance can be verified using the provided registration numbers and FEI numbers listed in the device specifications, which are essential for tracking and auditing purposes.
Can the Quantum PSI System be used in MRI environments, and what special considerations should be taken during storage?
No, the Quantum PSI System is explicitly stated as not MRI-compatible. Storage and handling should follow standard orthopedic device guidelines to ensure sterility and functionality, as outlined in the manufacturer’s instructions.
How do I determine which specific model or variant of the Quantum PSI System is compatible with my patient’s anatomy?
The Quantum PSI System is patient-specific instrumentation, meaning it is tailored to individual anatomy through pre-surgical planning. The exact model or variant is determined based on the patient’s unique anatomical measurements and surgical requirements, as provided by the manufacturer’s pre-operative planning tools.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230313 | Class II | Active |
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Manufacturer
- Manufacturer
- In2Bones SAS
Sources (2)
- FDA 510(k) K230313 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026