Ortholoc Advantim Porous Coated Tibial Base
510(k) K945087
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK945087 | Date17 Mar 1995 | 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- Withdrawn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
- JWH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3560
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Ortholoc Advantim Porous Coated Tibial Base is a porous-coated tibial component for total knee arthroplasty, designed to integrate with bone and provide stability in knee replacement procedures. Its porous coating enhances osseointegration, promoting long-term fixation and load-bearing capacity within the tibial plateau. This device is classified under orthopedic implants and is intended for use in primary or revision knee arthroplasty surgeries.
This tibial base is supplied as a sterile, single-use implant and is regulated under FDA 510(k) clearance (K945087) as substantially equivalent to prior-generation devices. It is intended for use in orthopedic settings, requiring surgical implantation by trained professionals. The device’s porous coating and design specifications are documented in the FDA submission, ensuring compliance with orthopedic implant standards. No additional regulatory markings beyond the FDA 510(k) clearance are referenced in the available data.
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Questions
AI-generated answers, 1 Oct 2026
What is the Ortholoc Advantim Porous Coated Tibial Base used for?
The Ortholoc Advantim Porous Coated Tibial Base is designed specifically for total knee arthroplasty, including both primary and revision surgeries. Its porous coating promotes osseointegration—direct bonding between bone and the implant—which improves long-term stability and load-bearing capacity in the tibial plateau. This makes it ideal for procedures requiring durable fixation in the knee joint.
How is the Ortholoc Advantim Porous Coated Tibial Base supplied?
This device is supplied as a sterile, single-use implant. Sterility ensures patient safety by preventing contamination during surgery, while single-use eliminates the need for reprocessing, reducing infection risks associated with reused medical devices. It must be handled under sterile conditions and used only once per patient.
Is the porous coating on this tibial base intended for any specific clinical outcomes?
Yes, the porous coating on the Ortholoc Advantim Tibial Base is engineered to enhance osseointegration, which is the biological process where bone grows into the porous structure of the implant. This integration provides stronger fixation to the tibial plateau, improving stability and load distribution during knee movement. The design supports long-term durability, particularly in patients with active lifestyles or those requiring revision surgery.
Can this tibial base be reused after a single surgical procedure?
No, this device is explicitly designed for single-use only. Reusing medical implants increases the risk of infection, mechanical failure, and compromised patient outcomes. The sterile packaging ensures it remains uncontaminated until first use, adhering to best practices in orthopedic surgery to maintain safety and efficacy.
What regulatory pathway does the Ortholoc Advantim Porous Coated Tibial Base follow?
The device is cleared under the FDA’s 510(k) pathway, specifically clearance number K945087, as substantially equivalent to prior-generation tibial bases. This classification means it meets FDA standards for safety and effectiveness by demonstrating equivalence to a legally marketed predicate device. The clearance is categorized under orthopedic implants and was reviewed by the Orthopedic Devices Advisory Committee.