iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair Syst…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K193105 FDA 510(k)
- FDA Product Code
- JWH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3560 FDA 510(k)
- Regulation Number
- 888.3560 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, and iTotal PS Knee Replacement System are custom-designed knee prostheses. The iUni targets unicompartmental osteoarthritis by replacing a single knee compartment, while the iDuo addresses bicompartmental osteoarthritis with a partial repair. The iTotal CR and iTotal PS are total knee replacements, with the CR retaining the anterior cruciate ligament and the PS substituting it for stability. These devices are engineered to restore joint function and reduce pain in patients with degenerative joint conditions.
These systems are intended for surgical use in orthopedic settings and are supplied sterile for single-use. Implantation requires surgical expertise and is tailored to patient-specific anatomy via custom fabrication. The devices fall under product code JWH and have received FDA 510(k) clearance as substantially equivalent. No MRI safety data is provided, and sizing is determined through patient-specific imaging. Storage and handling adhere to standard sterile orthopedic implant protocols.
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: iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee ..., Partial Knee Replacement Options | Conformis, Our Products - Conformis
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193105 | Class II | Active |
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Manufacturer
- Manufacturer
- Conformis, Inc.
Sources (1)
- FDA 510(k) K193105 24 fields · synced Sep 20, 2026