510(k) · Cleared

Cleared

Pitkar DeftFix System

K200728510(k) TraditionalCleared Oct 6, 2020200-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

S.H.Pitkar Orthotools Pvt., Ltd. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Oct 6, 2020 as substantially equivalent to K970748 (Smith & Nephew, Inc., Orthopaedic Div., 1997) after a 200-day review. Its family tree reaches back 1 generation to 1997.

Decided: Oct 6, 2020
Review: 200 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K970748 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK970748 Taylor Spatial Frame External Fixation SystemSmith & Nephew, Inc., Orthopaedic Div. · 1997
This deviceK200728 Pitkar DeftFix SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970748	Taylor Spatial Frame External Fixation System	Smith & Nephew, Inc., Orthopaedic Div.	1997	—
0 (this device)	K200728	Pitkar DeftFix System	S.H.Pitkar Orthotools Pvt., Ltd.	2020	—

FIG. 1 — Lineage of K200728, 1997–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K970748	Taylor Spatial Frame External Fixation System Summary page 4 …1 CFR 888.3030) Product Code: KTT, OSN Regulatory Class: II 3. Predicate Device(s): Smith & Nephew Inc.- Taylor Spatial Frame -K 970748 4. Device Description: The purpose of this submission is to request clearance for the…	Smith & Nephew, Inc., Orthopaedic Div.	1997	—

Also cleared against K970748: 13 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.
13 other devices also cite its predicate K970748.

How does its category compare?

All KTT devices

KTT 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

2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007high 200 (2020) · low 25 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KTT

2in 2021

2007high 14 (2018) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KTT

673in 2025

2007high 961 (2021) · low 45 (2007)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 Sixafix System is indicated for the following treatments in adults, and in both children (3-12) and adolescents

(12-21) in which the growth of plates have fused or will not be the crossed with the hardware.

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/K200728 · printed Nov 3, 2026

Cite this page

510(k) Report. “K200728: Pitkar DeftFix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200728

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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