510(k) · Cleared
ClearedPitkar External Fixation System - Rail Mechanism
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S.H.Pitkar Orthotools Pvt., Ltd. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jul 29, 2020 as substantially equivalent to K955848 (Orthofix, Inc., 1996) and 1 other predicate after a 149-day review. Its family tree reaches back 3 generations to 1980. 2 later devices descend from it.
- Decided
- Jul 29, 2020
- Review
- 149 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K802814 (1980). 10 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK802814 Orthofix Axialexternal Fixation Sys.Cintor Orthopaedic Div. · 1980
- 2 generations backK970751 Heidelberg External FixatorSmith & Nephew, Inc., Orthopaedic Div. · 1997
- 1 generation backK090926 Smith & Nephew Rail SystemSmith & Nephew, Inc. · 2009
- This deviceK200518 Pitkar External Fixation System - Rail MechanismS.H.Pitkar Orthotools Pvt., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK241357 XT3 SystemBiodynamik, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK260073 XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K802814 | Orthofix Axialexternal Fixation Sys. | Cintor Orthopaedic Div. | 1980 | — |
| −2 | K970751 | Heidelberg External Fixator | Smith & Nephew, Inc., Orthopaedic Div. | 1997 | — |
| −1 | K090926 | Smith & Nephew Rail System | Smith & Nephew, Inc. | 2009 | — |
| 0 (this device) | K200518 | Pitkar External Fixation System - Rail Mechanism | S.H.Pitkar Orthotools Pvt., Ltd. | 2020 | — |
| +1 | K241357 | XT3 System | Biodynamik, Inc. | 2025 | — |
| +2 | K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | Biodynamik, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KTT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KTT device
- #1 K242861 TrueLok Elevatescore 21.4 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K955848 | Orthofix ModulsystemSummary page 5…- Rail mechanism is similar to the primary predicate devices namely Orthofix Srl Orthofix Modulsystem – K955848 and secondary predicate device Smith & Nephew Rail System – K09… | 1996 |
| * | K090926 | Smith & Nephew Rail SystemSummary page 5…Orthofix Modulsystem – K955848 and secondary predicate device Smith & Nephew Rail System – K090926 Materials & Chemical Composition: Pitkar External Fixation Syst… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241357 | XT3 System | 2025 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 40 years and passes through 4 companies; a new generation was cleared every 12.1 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K241357 (Biodynamik, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 13 other devices also cite its predicate K955848.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
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…
Read the full statement (165 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200518 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200518: Pitkar External Fixation System - Rail Mechanism.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200518
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026