510(k) · Cleared
ClearedPitkar External Fixation System
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 Oct 16, 2019 as substantially equivalent to K083789 (DePuy Orthopaedics, Inc., 2009) and 1 other predicate after a 230-day review. Its family tree reaches back 2 generations to 1980. 2 later devices descend from it.
- Decided
- Oct 16, 2019
- Review
- 230 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K801594 (1980). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK801594 Ace Fischer External Fixation DeviceAce Orthopedic Manufacturing Co. · 1980
- 1 generation backK083789 Ace Fischer External Fixation SystemDePuy Orthopaedics, Inc. · 2009
- This deviceK190486 Pitkar External Fixation SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK202833 Sequel External Fixation DeviceSequel Medical, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK253291 Excelsior SystemBlue Ocean Global · 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 |
|---|---|---|---|---|---|
| −2 | K801594 | Ace Fischer External Fixation Device | Ace Orthopedic Manufacturing Co. | 1980 | — |
| −1 | K083789 | Ace Fischer External Fixation System | DePuy Orthopaedics, Inc. | 2009 | — |
| 0 (this device) | K190486 | Pitkar External Fixation System | S.H.Pitkar Orthotools Pvt., Ltd. | 2019 | — |
| +1 | K202833 | Sequel External Fixation Device | Sequel Medical, Inc. | 2021 | — |
| +2 | K253291 | Excelsior System | Blue Ocean Global | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 21.3 · 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 |
|---|---|---|---|
| * | K083789 | Ace Fischer External Fixation SystemSummary page 4…W – Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) Predicate Device(s): K083789 ACE-Fischer DePuy Orthopaedics External Fixation… | 2009 |
| * | K970748 | Taylor Spatial Frame External Fixation SystemSummary page 4…External Fixation System K970748 Taylor Spatial Smith & Frame Nephew, Inc.… | 1997 |
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 |
|---|---|---|---|
| K202833 | Sequel External Fixation Device | 2021 | 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 39 years and passes through 3 companies; a new generation was cleared every 28.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K202833 (Sequel Medical, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K083789.
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. 2019, 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?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190486 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190486: Pitkar External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190486
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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