Osteomed Temporary Condylar Attachment System

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

510(k) Number

K031701 ↗

FDA Product Code

NEI

Device Class

Class II

Regulation

21 CFR Part 872.4770

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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See all devices from Osteomed LP →

• What is the primary purpose of the Osteomed Temporary Condylar Attachment System in dental surgery?

  The system is designed to provide temporary stabilization for mandibular condylar reconstruction. It attaches a solid condylar head to an Osteomed Locking Fracture Reconstruction Plate via fastening screws, ensuring secure positioning during the healing process in dental surgical settings.

• Is the Osteomed Temporary Condylar Attachment System intended for reuse or single-use, and why?

  The system is explicitly intended for single-use in dental surgical settings. This is due to its classification as a sterile, ready-to-use kit, which ensures patient safety and compliance with sterile handling protocols for medical devices.

• What configurations are available for the Osteomed Temporary Condylar Attachment System, and how does this affect its use?

  The system is available in right and left configurations, allowing for precise anatomical alignment during mandibular condylar reconstruction. This ensures compatibility with the patient’s specific jaw structure and facilitates proper surgical placement.

• Does the Osteomed Temporary Condylar Attachment System come with any tools, and if so, what are they included?

  Yes, the system is supplied as a sterile, ready-to-use kit that includes screwdrivers specifically designed for placement. These tools are essential for securely attaching the condylar head to the locking plate during surgery.

• How should the Osteomed Temporary Condylar Attachment System be stored to maintain its sterility?

  Since the system is provided as a sterile, ready-to-use kit, it should be stored in its original packaging until immediately before use. The packaging should remain unopened and protected from contamination to preserve sterility, as required for single-use medical devices.