Identifiers
- 510(k) Number
- K182301 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 PFC Sigma Knee System is a total knee replacement prosthesis designed for arthroplasty procedures. It is classified as a knee joint replacement device, intended to restore function and alleviate pain in patients with severe degenerative joint conditions, including osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, collagen disorders, or pseudogout. The system features modular components to accommodate varying surgical philosophies and anatomical requirements, ensuring customizable fit and alignment.
This device is supplied as a sterile, single-use implant intended for surgical use in orthopedic settings. It is regulated under FDA 510(k) clearance (K182301) as substantially equivalent to prior-generation knee systems, adhering to traditional review pathways. Components are designed for MRI safety where applicable, and the system is distributed in sterile packaging for immediate intraoperative use. No additional sterilization or reprocessing is required.
Frequently asked questions
What types of degenerative joint conditions is the PFC Sigma Knee System intended to address in patients?
The PFC Sigma Knee System is designed for patients suffering from severe degenerative joint conditions such as osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, collagen disorders, or pseudogout. It aims to restore function and alleviate pain by replacing damaged knee joints, offering modular components to adapt to different anatomical needs and surgical approaches.
Is the PFC Sigma Knee System meant for reuse in surgical settings, or is it single-use only?
The PFC Sigma Knee System is explicitly supplied as a sterile, single-use implant. It is packaged for immediate intraoperative use, and the manufacturer states no additional sterilization or reprocessing is required, ensuring compliance with surgical best practices for implant safety.
How does the modular design of the PFC Sigma Knee System benefit surgeons during knee arthroplasty?
The modular components of the PFC Sigma Knee System allow surgeons to customize the prosthesis to fit individual patient anatomy and align with their preferred surgical techniques. This flexibility accommodates varying anatomical requirements and ensures a tailored fit, potentially improving outcomes and stability for the patient.
What regulatory pathway was followed for FDA clearance of the PFC Sigma Knee System, and how does it compare to prior-generation knee systems?
The PFC Sigma Knee System received FDA clearance through a 510(k) submission (K182301) under the Traditional Review pathway, with a decision of Substantially Equivalent (SESE) to prior-generation knee systems. This means the FDA determined it shares the same intended use and technological characteristics as existing devices, ensuring compliance with established safety and effectiveness standards.
Are the components of the PFC Sigma Knee System compatible with MRI scans, and how should they be stored before use?
The PFC Sigma Knee System components are designed for MRI safety where applicable, though specific MRI compatibility should be verified per the device labeling. The system is supplied in sterile packaging and should be stored in a clean, dry environment at room temperature until ready for intraoperative use, as no additional sterilization is required.
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: SIGMA® Total Knee System | P.F.C | DePuy Synthes, PDF P.F.C.® SIGMA® Total Knee System, Depuy | PFC Sigma Knee System - Which Medical Device
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182301 | Class II | Active |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA 510(k) K182301 24 fields · synced Sep 20, 2026