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Precimed Cannulated Screw System

by Precimed, Inc.

510(k) K050754

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050754 Date18 May 2005ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Precimed Cannulated Screw System is a Cannulated Screw System (product code HWC) designed for orthopedic fixation. It provides immediate stability and temporary fixation during the natural healing process of bone fractures and reconstructions. The system consists of metallic screws available in varying diameters and lengths, allowing customisation for surgical applications. Its cannulated design facilitates insertion over guide wires, enhancing precision and reducing trauma to surrounding tissue.

This device is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified as Class II under FDA regulations and holds a FDA 510(k) clearance (K050754) for orthopedic fixation applications. Screws are available in multiple sizes, ensuring compatibility with diverse clinical scenarios. Storage and handling must adhere to sterile medical device protocols to maintain integrity prior to use.

Other devices from Precimed, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Precimed Cannulated Screw System used for?

    The Precimed Cannulated Screw System is designed for orthopedic fixation, providing immediate stability and temporary support during the natural healing process of bone fractures and reconstructions. Its cannulated design allows screws to be inserted over guide wires, reducing trauma to surrounding tissue and improving precision during surgery.

  • How is the Precimed Cannulated Screw System supplied and intended for use?

    The system is supplied sterile and is intended for single-use in orthopedic surgical settings. This ensures safety and sterility during procedures, adhering to medical device protocols for optimal patient outcomes.

  • Are the screws in this system reusable or single-use?

    The screws in the Precimed Cannulated Screw System are designed for single-use only. This design choice aligns with sterile medical device standards to prevent contamination and ensure patient safety during surgical procedures.

  • What sizes of screws are available in the Precimed Cannulated Screw System?

    The system includes metallic screws available in varying diameters and lengths, allowing for customization to fit diverse clinical scenarios. This flexibility ensures compatibility with different surgical needs and patient anatomies.

  • How should the Precimed Cannulated Screw System be stored and handled?

    Storage and handling of the Precimed Cannulated Screw System must follow strict sterile medical device protocols to maintain its integrity before use. Proper storage ensures the sterility and functionality of the screws, which is critical for successful surgical outcomes.