Skip to content

IRENE Cannulated Screw System

by Tianjin Zhengtian Medical Instrument Co., Ltd.

510(k) K170056

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170056 Date23 Oct 2017ClearedStatusActive

Official records

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

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 Irene Cannulated Screw System is a metallic bone fixation fastener classified under Smooth or Threaded Metallic Bone Fixation Fastener (21 CFR 888.3040). It consists of cannulated screws designed for orthopedic applications, providing internal fixation to stabilize bone fractures or assist in joint reconstruction procedures. These screws feature a hollow core to accommodate guidewires, allowing for precise placement through existing tunnels or drill holes. The system is intended for use in orthopedic surgeries where secure, internal fixation is required.

The device is supplied as a reusable orthopedic implant and is regulated under FDA 510(k) clearance (K170056) as substantially equivalent to predicate devices. It is intended for use in sterile surgical settings and must be handled according to standard aseptic techniques. The cannulated design supports minimally invasive techniques, reducing soft tissue trauma. No specific MRI safety classification is stated in the regulatory data, and the system is categorized under product code HWC for orthopedic fixation devices.

Other devices from Tianjin Zhengtian Medical Instrument Co., Ltd.

See all devices from Tianjin Zhengtian Medical Instrument Co., Ltd. →