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ODI Ultimate Compression Hip Screw

by Orthopedic Designs, Inc.

510(k) K984331

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 NumberK984331 Date20 Jan 1999ClearedStatusActive

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  • Withdrawn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 ODI Ultimate Compression Hip Screw is a hip screw classified under the FDA product code HWC, designed for internal fixation of femoral fractures. It provides stable compression across fracture sites to promote proper bone alignment and healing, utilising a threaded design to anchor within cortical bone. Constructed for orthopaedic applications, it is intended for use in surgical procedures requiring rigid fixation of hip or proximal femoral fractures. The device’s compression mechanism helps maintain reduction while allowing controlled axial loading during the healing process.

This device is supplied as a single-use, sterile orthopaedic implant intended for surgical use only. It is manufactured from materials compliant with FDA standards and cleared under FDA 510(k) clearance (K984331) as substantially equivalent to predicate devices in the Orthopaedic advisory committee category. The screw is not MRI-safe and must be handled using aseptic techniques in an operating room setting. Storage requires adherence to manufacturer-provided instructions to preserve sterility and integrity prior to use.

Other devices from Orthopaedic Designs, 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 ODI Ultimate Compression Hip Screw used for?

    The ODI Ultimate Compression Hip Screw is designed for internal fixation of femoral fractures, particularly in the hip or proximal femur region. Its threaded design provides stable compression across fracture sites, helping maintain proper bone alignment and facilitating healing during the recovery process. This mechanism also allows controlled axial loading, which supports the natural healing process while the bone consolidates.

  • Is the ODI Ultimate Compression Hip Screw single-use or reusable?

    The ODI Ultimate Compression Hip Screw is intended for single-use only. It is supplied sterile and intended exclusively for surgical procedures in an operating room setting. Reuse is not recommended due to potential compromises in sterility, structural integrity, or risk of infection, which could adversely affect patient outcomes.

  • How should the ODI Ultimate Compression Hip Screw be stored?

    Storage of the ODI Ultimate Compression Hip Screw must follow the manufacturer’s instructions to preserve its sterility and structural integrity. It should be kept in its original packaging, protected from moisture, contamination, and physical damage. The packaging is designed to maintain a sterile barrier until immediate preoperative use, ensuring aseptic handling in the operating room.

  • Can the ODI Ultimate Compression Hip Screw be used with MRI imaging?

    No, the ODI Ultimate Compression Hip Screw is not MRI-safe. It contains metallic components that could generate heat or artifacts during MRI scans, posing risks to both the patient and the imaging equipment. Clinicians should avoid MRI procedures involving this device unless explicitly cleared by the manufacturer or radiology team.

  • What materials does the ODI Ultimate Compression Hip Screw comply with?

    The ODI Ultimate Compression Hip Screw is manufactured from materials compliant with FDA standards, ensuring suitability for orthopedic implants. While specific material compositions are not detailed in the provided data, the device has undergone FDA review (510(k) clearance K984331) to confirm its safety, performance, and equivalence to predicate devices in the Orthopedic Advisory Committee category.