Conformis BiCompartmental Knee Repair System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K053488 FDA 510(k)
- FDA Product Code
- NPJ 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 Conformis BiCompartmental Knee Repair System is a Prosthesis, Knee Patellofemoral, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, designed for bicompartmental knee replacement. It is intended for patients with severe knee joint pain and disability requiring treatment beyond single-compartment prostheses, such as unicondylar or patellofemoral implants. The system is engineered to restore joint function and alleviate pain by addressing degenerative conditions affecting multiple knee compartments simultaneously. Its semi-constrained design balances stability and natural knee motion while accommodating individual anatomical variations.
This system is supplied as a sterile, single-use device and is MRI-safe per its regulatory classification. It is intended for cemented implantation in orthopedic settings by trained surgeons. The system includes multiple FEI numbers (e.g., 3005706667, 1000137563) corresponding to specific component sizes and configurations, ensuring compatibility with individual patient anatomy. Authorized under FDA 510(k) clearance (K053488), it adheres to Device Class II standards and is regulated under 21 CFR 888.3560. Storage and handling follow standard orthopedic implant protocols to maintain sterility and integrity.
Frequently asked questions
What conditions is the Conformis BiCompartmental Knee Repair System designed to treat?
This system is specifically intended for patients with severe knee joint pain and disability who require treatment beyond single-compartment prostheses, such as unicondylar or patellofemoral implants. It addresses degenerative conditions affecting multiple knee compartments simultaneously, restoring joint function and alleviating pain by accommodating individual anatomical variations.
How is the Conformis BiCompartmental Knee Repair System supplied and prepared for use?
The system is supplied as a sterile, single-use device, ensuring safety and compliance with orthopedic implant protocols. It is designed for cemented implantation in orthopedic settings by trained surgeons, with no reuse intended to maintain sterility and integrity.
Is the Conformis BiCompartmental Knee Repair System MRI-safe?
Yes, the Conformis BiCompartmental Knee Repair System is classified as MRI-safe according to its regulatory standards. This allows for MRI imaging of the knee post-implantation without interference, provided the device is used as intended and within its approved parameters.
What sizes and configurations are available for the Conformis BiCompartmental Knee Repair System?
The system includes multiple FEI numbers corresponding to specific component sizes and configurations, ensuring compatibility with a wide range of patient anatomies. Examples include FEI numbers like 3005706667, 1000137563, and others, which cover various bicompartmental knee replacements. These variations allow surgeons to select the optimal fit for individual patients.
How should the Conformis BiCompartmental Knee Repair System be stored to maintain sterility?
The system must be stored following standard orthopedic implant protocols to preserve sterility and structural integrity. This includes maintaining sealed packaging, protecting from physical damage, and adhering to manufacturer guidelines for temperature and humidity control. Proper storage ensures the device remains ready for single-use implantation as intended.
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: Customized Knee Replacements | Conformis, Our Products - Conformis, CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM (K053488) — FDA 510 (k ..., Conformis Knee Replacement - accesssportsmed.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K053488 | Class II | Active |
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Manufacturer
- Manufacturer
- Conformis, Inc.
Sources (1)
- FDA 510(k) K053488 24 fields · synced Oct 1, 2026