Conformis Iuni Unicondylar Knee Replacement System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121974 FDA 510(k)
- FDA Product Code
- HSX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3520 FDA 510(k)
- Regulation Number
- 888.3520 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The iUni Unicompartmental Knee Replacement System is a bicruciate-retaining unicompartmental knee prosthesis designed to replace the damaged articular surface in either the medial or lateral compartment of an osteoarthritic knee. It is intended for patients with localized cartilage wear while preserving healthy bone and ligaments, including the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL). The system is personalized to match the patient’s unique anatomy, ensuring precise fit and alignment. Its design targets unicompartmental osteoarthritis, offering a minimally invasive alternative to total knee arthroplasty.
The system is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K121974) as substantially equivalent to predicate devices in the orthopedic category. Components are manufactured for MRI safety compatibility, though specific imaging protocols should be followed per facility guidelines. Storage requires adherence to sterile packaging instructions, and surgical use follows standard aseptic techniques. No additional regulatory approvals beyond the stated 510(k) are referenced in the device data.
Frequently asked questions
What is the iUni Unicompartmental Knee Replacement System designed for?
The iUni Unicompartmental Knee Replacement System is specifically designed to replace damaged articular cartilage in either the medial or lateral compartment of a knee affected by osteoarthritis. It preserves healthy bone and ligaments, including the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL), making it ideal for patients with localized cartilage wear who do not require a total knee replacement. The system provides a minimally invasive alternative to broader arthroplasty procedures.
How is the iUni system personalized for patients?
The iUni system is personalized to match each patient’s unique knee anatomy, ensuring precise fit and alignment. This customization is achieved through advanced imaging and manufacturing techniques that tailor the prosthesis to the individual’s specific joint geometry, optimizing function and longevity.
Is the iUni Unicompartmental Knee Replacement System sterile and single-use?
Yes, the iUni system is supplied sterile and intended for single-use only. This design ensures patient safety by minimizing the risk of infection and contamination, aligning with standard surgical best practices for orthopedic implants.
What regulatory clearance does the iUni system hold?
The iUni Unicompartmental Knee Replacement System holds FDA 510(k) clearance (K121974), confirming it is substantially equivalent to predicate devices in the orthopedic category. This clearance validates its safety and effectiveness for the intended use as described in the device data.
Can the iUni system be used with MRI imaging, and are there any precautions?
The components of the iUni system are manufactured with MRI safety compatibility in mind. However, specific imaging protocols should be followed per facility guidelines to ensure safe and accurate MRI use. Always consult your facility’s radiology department for detailed instructions.
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: Our Products - Conformis, Customized Knee Replacements | Conformis, Partial Knee Replacement Options | Conformis, CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM by CONFORMIS, INC ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121974 | Class II | Active |
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Manufacturer
- Manufacturer
- Conformis, Inc.
Sources (1)
- FDA 510(k) K121974 24 fields · synced Oct 1, 2026