P.F.C. Modular Plus Offset Tibial Tray

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K984158 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What types of knee surgeries is this tibial tray designed for, and why is the offset feature important?

  This P.F.C. Modular Plus Offset Tibial Tray is specifically designed for total knee arthroplasty (TKA), a procedure to replace damaged knee joints. The offset feature—where the baseplate is positioned away from the central stem—addresses anatomical variations in the tibial canal, ensuring a more precise fit and improved stability during implantation. This helps accommodate patients whose tibial canals are not perfectly centered, reducing the risk of malalignment and enhancing long-term implant performance.

• How is this device fixed in place during surgery, and what materials are used?

  Fixation is achieved through polymethylmethacrylate (PMMA) bone cement, which bonds the tibial tray to the bone. The tray includes a keel geometry for deeper insertion and cement pockets with four screw holes, allowing optional wedge attachment for additional stability. The device itself is constructed from polymer, metal, and polymer layers, combining durability with biocompatibility for long-term use.

• Is this tibial tray reusable, or is it intended for single-use only? How should it be stored?

  The P.F.C. Modular Plus Offset Tibial Tray is supplied as a single-use, sterile component, meaning it is not designed for reuse. To maintain sterility before use, it should be stored in its original packaging in a clean, dry environment, away from direct sunlight or extreme temperatures, as recommended by the manufacturer. Proper storage ensures the device remains uncontaminated until implantation.

• What regulatory pathway was followed for FDA clearance, and what does that mean for clinicians?

  This device received FDA clearance via a 510(k) submission (K984158), determined to be substantially equivalent to a predicate device under Product Code JWH (Orthopedic Knee Prosthesis). The clearance was reviewed by the Orthopedic Devices Advisory Committee (OR) and classified as a traditional 510(k). For clinicians, this means the device has undergone FDA evaluation for safety and effectiveness in its intended use for total knee arthroplasty, adhering to established orthopedic standards.