SynPlug Cement Obturator

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Synplug

510(k) Number

K010840 ↗

FDA Product Code

LZN

Device Class

Class II

Regulation

21 CFR Part 878.3300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the SynPlug used for in orthopedic procedures and how does it improve surgical precision?

  The SynPlug is a Cement Obturator designed to seal and block bone cement during orthopedic surgeries, preventing unintended leakage into spaces like the medullary canal or soft tissues. By obstructing cement flow, it enhances precision in procedures such as joint replacements or fracture repairs, ensuring cement stays where intended for better surgical outcomes.

• Is the SynPlug intended for single-use or can it be reused in multiple procedures?

  The SynPlug is explicitly supplied as a single-use, sterile instrument, meaning it is intended for one-time clinical use only. Reusing it would compromise sterility and could introduce infection risks, so adherence to single-use guidelines is critical.

• What storage instructions should be followed to maintain the SynPlug’s sterility?

  The SynPlug must be stored according to the manufacturer’s guidelines to preserve sterility. While specific conditions aren’t detailed here, typical best practices for single-use sterile devices—such as keeping packaging intact, avoiding contamination, and storing in a clean, dry environment—should be followed.

• How was the SynPlug’s regulatory pathway determined, and what does its classification as a Class II device imply?

  The SynPlug was cleared via a FDA 510(k) pathway (K010840) under Special Review by the Orthopaedic Devices Panel (OR), with a decision of Substantially Equivalent (SESE). Its classification as a Class II device under FDA regulation 878.3300 indicates it carries moderate risk and requires premarket notification (510(k)) to ensure safety and effectiveness before commercial distribution.