# K190486: Pitkar External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: S.H.Pitkar Orthotools Pvt., Ltd.
- Decided: Oct 16, 2019 after 230 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: 2 generations back to K801594 (1980). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083789: Ace Fischer External Fixation System, DePuy Orthopaedics, Inc. (2009) Summary page 4.
- K970748: Taylor Spatial Frame External Fixation System, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 4.

## Most influential descendants
- K202833: Sequel External Fixation Device (2021), 1 descendant of its own
- K253291: Excelsior System (2026), 0 descendants of its own

## Indications for use
The Pitkar External Fixation System is indicated for both adults and pediatric patients for: 1. Open and closed fracture fixation 2. Pseudoarthrosis or non-union of long bones 3. Limb lengthening by epiphyseal or metaphyseal distraction 4. Correction of bony or soft tissue deformities 5. Correction of segmental or nonsegmental bony or soft tissue defects 6. Post-Traumatic joint contracture which has resulted in loss of range of motion

Source page: https://510kreport.com/device/K190486
Methodology: https://510kreport.com/methodology