Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K260536 FDA 510(k)
- FDA Product Code
- KWL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3360 FDA 510(k)
- Regulation Number
- 888.3360 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Prostalac Hip System with SmartSet V+G Dual Antibiotic Bone Cement is a femoral hip prosthesis designed for use in total hip arthroplasty. It combines a modular femoral component with a dual-antibiotic bone cement to enhance infection resistance and fixation during surgical implantation.
This system is intended for use in orthopedic surgical settings and is supplied as a sterile, single-use device. The SmartSet V+G bone cement incorporates vancomycin and gentamicin to reduce perioperative infection risk. The modular femoral components are available in multiple sizes and configurations, as listed in the provided FEI numbers, and are regulated under FDA 510(k) clearance and EU MDR compliance. Storage and handling must adhere to manufacturer guidelines to maintain sterility and performance.
Frequently asked questions
What types of femoral sizes and configurations are available for the Prostalac Hip System, and how does this modularity benefit the surgeon?
The Prostalac Hip System offers a wide range of modular femoral components, with over 100 distinct FEI numbers listed, covering various sizes and configurations. This modularity allows surgeons to select the most appropriate implant for each patient’s anatomy, ensuring a precise fit and tailored fixation during total hip arthroplasty. The variety supports customization for different patient morphologies, improving surgical outcomes and stability.
Is the SmartSet V+G Dual Antibiotic Bone Cement reusable, and if not, how should it be handled to maintain sterility?
The SmartSet V+G Dual Antibiotic Bone Cement is supplied as a single-use device, meaning it is intended for one surgical procedure only. To maintain sterility, it must be stored and handled according to the manufacturer’s guidelines, typically in a sealed, sterile packaging until use. Reusing the cement could compromise its sterility and effectiveness, particularly the antibiotic properties (vancomycin and gentamicin), which are designed to reduce perioperative infection risk.
What regulatory pathways does the Prostalac Hip System follow, and how does this affect its availability in different markets?
The Prostalac Hip System is cleared under FDA 510(k) (traditional pathway, substantially equivalent) and complies with EU MDR (Medical Device Regulation). This dual regulatory clearance allows the device to be legally marketed in both the U.S. and the European Economic Area, provided local compliance requirements (e.g., labeling, post-market surveillance) are met. The system’s orthopedic classification and advisory committee designation (OR) further support its use in total hip arthroplasty procedures.
How does the inclusion of vancomycin and gentamicin in the SmartSet V+G cement reduce infection risk during hip replacement surgery?
The SmartSet V+G Dual Antibiotic Bone Cement incorporates vancomycin and gentamicin, two broad-spectrum antibiotics, to create a localized antimicrobial barrier at the implant site. These antibiotics are released gradually during cement polymerization, helping to inhibit bacterial growth and reduce the risk of perioperative infections—a critical concern in joint replacement surgeries. This feature is particularly beneficial for patients at higher infection risk, such as those with compromised immune systems or prior infections.
What should clinicians consider when selecting a femoral component size from the Prostalac Hip System’s extensive FEI catalog?
When selecting a femoral component size, clinicians should prioritize anatomical fit to ensure proper alignment and load distribution, as well as patient-specific factors like bone density, activity level, and surgical approach. The system’s FEI numbers correspond to specific dimensions, so preoperative imaging (e.g., CT or X-ray templates) is essential to match the implant to the patient’s femoral canal. Overly large or small components could lead to instability, improper fixation, or excessive stress on surrounding bone, potentially compromising long-term outcomes.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K260536 | Class II | Active |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
Sources (2)
- FDA 510(k) K260536 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026