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Injection Screw

by Biedermann Medtech, Inc.

510(k) K173556

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 NumberK173556 Date13 Jul 2018ClearedStatusActive

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  • Withdrawn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 Injection Screw (Model MDS) is a bone fixation device classified as a Screw, Fixation, Bone under product code HWC. It is designed to provide stable internal fixation for orthopedic procedures, particularly in extremity applications, by securing bone fragments together during the healing process. Constructed for use with polyaxial locking plate systems, it ensures precise alignment and mechanical stability. This device is intended for surgical use in orthopedic trauma settings where secure fixation is required.

The Injection Screw (Model MDS) is supplied sterile and intended for single-use. It is regulated under 21 CFR 888.3040 and holds an FDA 510(k) clearance (K173556), granted on July 13, 2018, following a review by the Orthopedic (OR) Advisory Committee. The device is intended for use in sterile surgical environments and must be handled according to standard aseptic techniques. No additional regulatory markings or MRI safety classifications are specified in the available data.

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 Injection Screw (Model MDS) used for?

    The Injection Screw (Model MDS) is a bone fixation device intended for orthopedic procedures, specifically to secure bone fragments together during the healing process in extremity applications. It is designed to work with polyaxial locking plate systems to ensure precise alignment and mechanical stability, making it ideal for orthopedic trauma settings where secure internal fixation is required.

  • How is the Injection Screw (Model MDS) supplied and intended for use?

    The Injection Screw (Model MDS) is supplied sterile and is intended for single-use only. It must be used in sterile surgical environments, adhering to standard aseptic techniques to maintain its integrity and ensure patient safety.

  • Is the Injection Screw (Model MDS) reusable or single-use?

    The Injection Screw (Model MDS) is explicitly designed for single-use only. This ensures sterility and reduces the risk of infection or contamination, which is critical in surgical environments where precision and reliability are paramount.

  • What regulatory approval does the Injection Screw (Model MDS) hold?

    The Injection Screw (Model MDS) holds an FDA 510(k) clearance (K173556), granted on July 13, 2018. It was reviewed by the Orthopedic (OR) Advisory Committee and classified under 21 CFR 888.3040 as substantially equivalent to a predicate device. This clearance confirms its compliance with U.S. regulatory standards for bone fixation devices.

  • Are there any special handling or storage requirements for the Injection Screw (Model MDS)?

    While specific storage instructions are not detailed in the available data, the Injection Screw (Model MDS) must be handled as a sterile, single-use device. It should be stored in a clean, dry environment, protected from contamination, and used within its expiration date if applicable. Always follow manufacturer guidelines for optimal performance and safety.