iUni Unicondylar Knee Replacement System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132640 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 Unicondylar Knee Replacement System is a custom-made orthopedic implant designed for unicompartmental knee arthroplasty. It replaces the damaged articular surface in one compartment of an osteoarthritic knee, preserving healthy bone and retaining both the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL). This device is intended for patients with medial or lateral compartment osteoarthritis who have sufficient healthy bone to support the implant components. The system is classified as a bicruciate-retaining knee replacement, ensuring ligament integrity during the procedure.
The iUni Unicondylar Knee Replacement System is supplied as a sterile, single-use orthopedic implant. It is used in an operating room setting by orthopedic surgeons for partial knee replacement procedures. The system is regulated under FDA 510(k) clearance (K132640) and is intended for use in patients with unicompartmental osteoarthritis. Storage and handling must comply with standard orthopedic implant protocols to maintain sterility and functionality.
Frequently asked questions
What is the iUni Unicondylar Knee Replacement System used for?
This system is designed for unicompartmental knee arthroplasty, replacing only the damaged articular surface in one compartment of an osteoarthritic knee. It preserves healthy bone and retains both the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL), making it ideal for patients with medial or lateral compartment osteoarthritis who still have sufficient healthy bone to support the implant components.
Is the iUni Unicondylar Knee Replacement System single-use or reusable?
The iUni Unicondylar Knee Replacement System is supplied as a sterile, single-use device. This ensures patient safety and sterility for each procedure, as reuse could compromise the integrity and sterility of the implant.
How is the iUni Unicondylar Knee Replacement System stored and handled?
Storage and handling must comply with standard orthopedic implant protocols to maintain sterility and functionality. This includes keeping the device in its original packaging until use, protecting it from contamination, and following manufacturer guidelines for shelf life and environmental conditions.
Does this system require removal of both cruciate ligaments?
No, the iUni Unicondylar Knee Replacement System is a bicruciate-retaining knee replacement. This means it preserves both the ACL and PCL during the procedure, which helps maintain knee stability and natural joint function.
What regulatory clearance does the iUni Unicondylar Knee Replacement System have?
The system is regulated under FDA 510(k) clearance with the reference number K132640. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets applicable safety and effectiveness standards.
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: Partial Knee Replacement Options | Conformis, Our Products - Conformis, CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM by CONFORMIS, INC ..., Conformis Iuni Unicondylar Knee Replacement System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132640 | Class II | Active |
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Manufacturer
- Manufacturer
- Conformis, Inc.
Sources (1)
- FDA 510(k) K132640 24 fields · synced Oct 1, 2026