Syrigene Pre-Filled Syringe

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K935669 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What specific orthopedic procedures is the Syrigene Pre-Filled Syringe designed to assist with, and why is this important for surgical planning?

  The Syrigene Pre-Filled Syringe is specifically designed for hip arthroplasty procedures, particularly as a delivery system for bone cement during the implantation of semi-constrained metal-cemented acetabular components. This precision in design ensures controlled application of bone cement, which is critical for achieving proper fixation and stability in the acetabular region during hip replacement surgeries.

• Is the Syrigene Pre-Filled Syringe reusable, or is it intended for single-use only? How does this affect its use in a sterile surgical environment?

  The Syrigene Pre-Filled Syringe is explicitly intended for single-use only in sterile surgical environments. This design ensures patient safety by preventing cross-contamination and maintaining aseptic conditions, which is essential in orthopedic procedures where infection risks can significantly impact outcomes.

• What storage or handling precautions should be taken with the Syrigene Pre-Filled Syringe before use, and why are these important?

  The device requires adherence to standard sterile surgical protocols during storage and handling, though no additional specific instructions are provided. This is critical because orthopedic procedures demand sterile conditions to minimize infection risks, and improper handling could compromise the integrity of the pre-filled syringe or introduce contaminants.

• Are there different sizes or models of the Syrigene Pre-Filled Syringe, and if so, how might a clinician determine which one to use for a particular patient?

  The provided data does not specify distinct sizes or models of the Syrigene Pre-Filled Syringe beyond its classification as a delivery system for bone cement in hip arthroplasty. Clinicians should rely on the manufacturer’s guidelines or surgical protocol recommendations, as the choice may depend on factors like cement volume requirements or specific surgical technique preferences.

• Can the Syrigene Pre-Filled Syringe be used in imaging studies like MRI, or are there any restrictions related to its material composition?

  The Syrigene Pre-Filled Syringe is not MRI-safe, meaning it should not be used in or near MRI environments. This restriction is important because MRI-compatible materials are essential for imaging post-surgery, and using non-compatible devices could interfere with diagnostic accuracy or pose safety risks.