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Mitek Cancellous Fixation Screw, Cortical Fixation Screw, Soft Tissue Washer

by Mitek Surgical Products, Inc.

510(k) K934366

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)SN Traditional NumberK934366 Date7 Oct 1994DecidedStatusActive

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  • Withdrawn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
SN

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 Mitek Cancellous Fixation Screw, Cortical Fixation Screw, and Soft Tissue Washer are orthopedic fixation devices designed for internal bone stabilization and soft tissue management. The cancellous screw is intended for use in cancellous bone, providing secure fixation in spongy bone structures, while the cortical screw is engineered for denser cortical bone. The soft tissue washer is used to distribute forces and protect surrounding tissues during fixation procedures.

These devices are supplied sterile and intended for single-use in surgical settings. They are classified under FDA product code HWC and were granted FDA 510(k) clearance under K934366, with a decision dated October 7, 1994. The screws are part of a traditional 510(k) submission reviewed by the Orthopedic (OR) Advisory Committee and are not intended for MRI use. Storage and handling must comply with sterile surgical instrument protocols.

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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 are the Mitek Cancellous and Cortical Fixation Screws designed for?

    The Mitek Cancellous Fixation Screw is specifically engineered for secure fixation in spongy cancellous bone, while the Cortical Fixation Screw is intended for denser cortical bone. Both are used in orthopedic procedures to stabilize internal bone structures during surgical interventions.

  • How are these devices supplied and intended for use?

    These devices are supplied sterile and are intended exclusively for single-use in surgical settings. They follow standard sterile surgical instrument protocols and are not designed for reuse or repeated use in the same patient.

  • Are the screws compatible with MRI imaging?

    No, these screws are explicitly not intended for MRI use. Their design and materials are not optimized for magnetic resonance imaging environments, so they should not be used in procedures involving MRI.

  • What is the regulatory status of these devices?

    The Mitek Cancellous Fixation Screw, Cortical Fixation Screw, and Soft Tissue Washer received FDA 510(k) clearance under K934366, with a decision dated October 7, 1994. The clearance was granted under the Orthopedic (OR) Advisory Committee and classified under product code HWC.

  • How should these devices be stored to maintain sterility?

    These devices must be stored and handled according to sterile surgical instrument protocols to ensure sterility. Proper storage conditions, such as sealed packaging and controlled environments, are essential to prevent contamination before use.