NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta
510(k) K143100
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK143100 | Date5 Mar 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LOD
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3027
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The NP Cement Genta series comprises radiopaque polymethylmethacrylate (PMMA) bone cements designed for orthopedic use. These cements are formulated to secure artificial joint prostheses to host bone during the second stage of a two-stage revision arthroplasty following infection clearance. Available in both high-viscosity (HV) and low-viscosity (LV) formulations, they provide tailored fixation properties for varying clinical scenarios.
The NP Cement Genta products are supplied as powder and liquid components for manual mixing, while the NP Cement System Genta integrates storage, mixing, and extrusion into a single closed syringe-like device. All variants are intended for single-use and are regulated under FDA 510(k) clearance (K143100) as Class II devices. They are not MRI-safe and must be stored according to manufacturer instructions to maintain sterility and performance.
Other devices from Cossington, Ltd.
Questions
AI-generated answers, 19 Sep 2026
What is the NP Cement Genta series primarily used for in orthopedic surgery?
The NP Cement Genta series is designed specifically for securing artificial joint prostheses to host bone during the second stage of a two-stage revision arthroplasty after infection has been cleared. This ensures stable fixation of the prosthesis in cases where prior infection required removal and reimplantation.
Are the NP Cement Genta products single-use or reusable, and how are they supplied?
The NP Cement Genta products are intended for single-use only. They are supplied as powder and liquid components that require manual mixing. The NP Cement System Genta, however, integrates storage, mixing, and extrusion into a single closed syringe-like device, streamlining the preparation process while maintaining single-use compliance.
What viscosity options are available, and how do they differ in clinical application?
The NP Cement Genta series offers two viscosity formulations: high-viscosity (HV) and low-viscosity (LV). The HV variant is designed for scenarios requiring stronger fixation, while the LV variant provides tailored adaptability for varying clinical scenarios, such as filling gaps or contours more easily during prosthesis reattachment.
How should these cements be stored to maintain sterility and performance?
The NP Cement Genta products must be stored according to the manufacturer’s instructions to preserve sterility and performance. Since they are single-use and radiopaque polymethylmethacrylate (PMMA) bone cements, improper storage—such as exposure to moisture, extreme temperatures, or prolonged light—could compromise their integrity before use.
Are these cements MRI-safe, and what regulatory pathway was followed for clearance?
The NP Cement Genta products are not MRI-safe, as explicitly stated in the manufacturer’s documentation. They were cleared through the FDA 510(k) pathway (K143100) as Class II devices, demonstrating substantial equivalence to predicate devices in orthopedic bone cement applications.