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Threaded Fixation Pin (K963433)

by Orthopaedic Biosystems, Ltd.

510(k) K963433

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 NumberK963433 Date6 Nov 1996ClearedStatusActive

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  • Withdrawn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)

Full name
Threaded Fixation Pin
510(k) Number
FDA Product Code
JDW
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Threaded Fixation Pin (K963433) is a surgical orthopedic device classified as a Fixation Pin, Threaded under the FDA’s product code JDW. It is designed for internal fixation and alignment of small bones in the hand and foot, providing mechanical stability during fracture healing or reconstructive procedures.

This device is supplied sterile and intended for single-use. It is regulated under the FDA’s 510(k) clearance process, with a traditional review pathway through the Orthopedic (OR) Advisory Committee. Approved in 1996 under K-number K963433, it adheres to orthopedic fixation standards for minor skeletal structures, with no noted MRI compatibility restrictions in the submitted data.

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Questions

AI-generated answers, 19 Sep 2026

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

  • What types of bones is this threaded fixation pin specifically designed for, and how does it help during surgery?

    This threaded fixation pin is designed for internal fixation and alignment of small bones in the hand and foot. It provides mechanical stability during fracture healing or reconstructive procedures by securing bone fragments together, ensuring proper alignment while the bone repairs itself.

  • Is this pin reusable, or is it meant for single-use only? How is it supplied?

    The threaded fixation pin is intended for single-use only and is supplied sterile to ensure patient safety. This design minimizes the risk of infection and contamination, which is critical in orthopedic surgery.

  • What regulatory pathway was followed for FDA clearance, and when was it originally approved?

    This device was cleared through the FDA’s 510(k) process, specifically under the traditional review pathway with a review by the Orthopedic (OR) Advisory Committee. It was originally approved in November 1996 under the K-number K963433 and remains classified under product code JDW for threaded fixation pins.

  • Are there any known restrictions on using this pin with MRI scans after surgery?

    Based on the submitted data, there are no noted MRI compatibility restrictions for this threaded fixation pin. However, as with all orthopedic hardware, clinicians should always verify compatibility with their specific MRI protocols and equipment before imaging.