# K200518: Pitkar External Fixation System - Rail Mechanism

- Pathway: 510(k) (Traditional)
- Applicant: S.H.Pitkar Orthotools Pvt., Ltd.
- Decided: Jul 29, 2020 after 149 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K802814 (1980). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955848: Orthofix Modulsystem, Orthofix, Inc. (1996) Summary page 5.
- K090926: Smith & Nephew Rail System, Smith & Nephew, Inc. (2009) Summary page 5.

## Most influential descendants
- K241357: XT3 System (2025), 1 descendant of its own
- K260073: XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm (2026), 0 descendants of its own

## Indications for use
Pitkar External Fixation System- Rail Mechanism consist of Rail Fixation System and ALFA Fixator System. Their components are intended to be used on adult or pediatric patients as required. A. Rail fixation System 1.Fracture fixation 2.For correcting diaphyseal deformities, metaphyseal deformities with or without shortenings 3.Correction of bony or soft tissue deformities 4.Limb Lengthening 5.For treating non-union and mal-union 6.Bone transport application B. ALFA Fixator System 1.Open and closed fracture fixation 2.Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; 3.Pseudoarthrosis of long bones; 4.Limb lengthening; 5.Infected fractures or non-unions; and 6.Correction of long bone deformities. Note: For Rail Fixation System and ALFA Fixator System 1. For Adult Assembly: Population to be adult males and females for given indications 2. For Pediatric Assembly: Population to be between age of 5 to 10 for given indications 3. It is recommended to avoid operating on children under the age of five, in case of pediatric application

Source page: https://510kreport.com/device/K200518
Methodology: https://510kreport.com/methodology