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Pitkar External Fixation System Rail Mechanism

by S.H.Pitkar Orthotools Pvt., Ltd. 510(k)

Active United States

510(k) K200518

Overview

The Pitkar External Fixation System Rail Mechanism is an orthopedic device comprised of the Rail Fixation System and the ALFA Fixator System. It is intended for use in fracture fixation, the correction of diaphyseal and metaphyseal deformities with or without shortenings, and the correction of bony or soft tissue deformities.

This system is designed for use on both adult and pediatric patients and includes various orthopedic implants such as tapered pins, Schanz pins, and pins with HAP coatings. The device has received FDA 510k clearance. It is manufactured by S.H. Pitkar Orthotools Pvt. Ltd.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200518 Date29 Jul 2020ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KTT
FDA applicant
S.H.Pitkar Orthotools Pvt. , Ltd.
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from S.H.Pitkar Orthotools Pvt., Ltd.

Questions

  • What is the intended use of the Pitkar External Fixation System?

    This system is designed for fracture fixation and the correction of bony or soft tissue deformities. It is also indicated for the correction of diaphyseal and metaphyseal deformities, including those involving limb shortening.

  • Which patient populations can be treated with this system?

    The Pitkar External Fixation System is designed for use on both adult and pediatric patients, allowing for versatility in orthopedic treatment across different age groups.

  • What components are included in the Pitkar External Fixation System?

    The system comprises the Rail Fixation System and the ALFA Fixator System. It includes various orthopedic implants such as tapered pins, Schanz pins, and pins with HAP coatings to facilitate secure fixation.

  • What is the regulatory status of this device?

    The Pitkar External Fixation System has received FDA 510k clearance under K-number K200518, confirming it has been found substantially equivalent to predicate devices for its intended orthopedic applications.