United U2 Femoral Component, PS, #7
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120507 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 United U2 Femoral Component, PS, #7 is a metallic femoral component classified as a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer. It is intended for use in total knee arthroplasty, providing a mechanical replacement for the femoral condyles to restore joint function and mobility in patients with degenerative or traumatic knee damage.
Implanted by orthopedic surgeons in a clinical or hospital setting, this component is secured via bone cement and designed to accommodate internal/external rotation of up to ±3.7°. Supplied sterile and intended for single-use, it adheres to FDA 510(k) clearance (K120507) under product code JWH. Storage and handling must comply with sterile orthopedic implant protocols to ensure integrity and safety.
Frequently asked questions
What is the primary use case for the United U2 Femoral Component, PS, #7 in knee replacement surgery?
The United U2 Femoral Component, PS, #7 is designed specifically for total knee arthroplasty, replacing the femoral condyles to restore joint function and mobility in patients suffering from degenerative or traumatic knee damage. It is a semi-constrained, cemented prosthesis intended to provide stability while accommodating natural knee movement, including internal and external rotation of up to ±3.7°. This makes it suitable for cases where patients require improved joint mechanics and pain relief.
Is this device single-use or reusable, and how should it be stored to maintain sterility?
The United U2 Femoral Component, PS, #7 is intended for single-use only and is supplied in a sterile condition. To preserve sterility, it must be stored and handled according to standard sterile orthopedic implant protocols, ensuring the packaging remains unopened and undamaged until immediate preoperative use. Improper storage or exposure could compromise its integrity and safety.
What size or model variations are available for this femoral component, and how does the ‘#7’ designation factor in?
The ‘#7’ designation in the United U2 Femoral Component, PS, #7 refers to a specific size variant within the product line, tailored to fit particular patient anatomies during total knee arthroplasty. While the provided data does not list all available sizes, the ‘PS’ in the name suggests it is part of a polyethylene-bearing system (polymer/metal/polymer construction) designed for semi-constrained applications. For exact sizing options, refer to the manufacturer’s catalog or surgical planning tools, as orthopedic implants require precise matching to patient-specific bone dimensions.
How is the United U2 Femoral Component, PS, #7 secured during surgery, and what does ‘cemented’ mean in this context?
The term ‘cemented’ indicates this femoral component is secured to the patient’s femur using bone cement (typically polymethylmethacrylate, or PMMA), which acts as an adhesive and structural support. During surgery, the surgeon prepares the femoral bone surface, applies the cement, and then presses the component into place while the cement hardens. This method ensures a stable, long-term fixation critical for weight-bearing and mobility post-surgery.
What regulatory pathway does this device follow, and how does the ‘FDA 510(k)’ clearance relate to its use?
The United U2 Femoral Component, PS, #7 follows the FDA 510(k) clearance pathway, classified under product code JWH (Prosthesis, Knee, Patellofemorotibial). This clearance indicates the manufacturer has demonstrated that the device is substantially equivalent to a legally marketed predicate device in terms of technology and safety. Clinically, this means it has undergone FDA review for compliance with orthopedic implant standards, ensuring it meets performance and risk criteria for use in total knee arthroplasty when implanted by trained orthopedic surgeons.
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: UNITED U2 FEMORAL COMPONENT, PS, #7 - Innolitics, UNITED U2 FEMORAL COMPONENT, PS, #7 510(k) K120507 - FDA.report, U2 PSA Knee | United Orthopedic Corporation | Hip and Knee Implants
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120507 | Class II | Active |
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Manufacturer
- Manufacturer
- United Orthopedic Corporation
Sources (1)
- FDA 510(k) K120507 24 fields · synced Oct 6, 2026