DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K201944 ↗

FDA Product Code

JEY

Device Class

Class II

Regulation

21 CFR Part 872.4760

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Synthes (USA) Products LLC →

• What is the primary use of the DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws?

  These screws are designed specifically for internal fixation in oral and maxillofacial surgery, particularly for securing mandibular plates. Their self-tapping mechanism allows for stable attachment to the mandible, making them ideal for fracture repair, trauma stabilization, and reconstructive procedures in this region. The titanium alloy construction ensures biocompatibility and corrosion resistance in the oral environment.

• Are these screws intended for single-use or reusable applications?

  The DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws are supplied sterile and explicitly intended for single-use only. This ensures patient safety by preventing cross-contamination and maintaining sterility during surgical procedures. Reuse is not recommended or supported by the manufacturer.

• What lengths are available for these screws, and how are they identified?

  These screws come in lengths ranging from 26mm to 40mm in 2mm increments. Each length is color-coded for easy identification during surgery, reducing the risk of selection errors. The color-coding system aligns with the MatrixMANDIBLE plating system for seamless integration.

• How should these screws be stored before use?

  The screws should be stored in their original sterile packaging until ready for use. The packaging must remain unopened and intact to preserve sterility. Store in a clean, dry environment away from direct sunlight or extreme temperatures, as recommended for medical devices. Follow the manufacturer’s instructions for proper handling and expiration dates.

• What material are these screws made from, and why is this important?

  The screws are manufactured from titanium alloy (Ti-6Al-7Nb), a material chosen for its strength, lightweight properties, and biocompatibility. Titanium alloy resists corrosion in the oral environment, reducing the risk of adverse reactions or failure over time. This material also provides excellent fatigue resistance, which is critical for long-term stability in fracture fixation.