510(k) · Cleared

Cleared

SIDEKICK EZ FRAME External Fixation System

K143220510(k) TraditionalCleared Jan 8, 201559-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

Wrightmedicaltechnologyinc · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Jan 8, 2015 as substantially equivalent to K130044 (Wrightmedicaltechnologyinc, 2013) after a 59-day review. Its family tree reaches back 2 generations to 2005.

Decided: Jan 8, 2015
Review: 59 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K043289 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK043289 E-Z Frame External Surgical Support BootSignal Medical Corp. · 2005
1 generation backK130044 Sidekick EZ Frame External Fixation SystemWrightmedicaltechnologyinc · 2013
This deviceK143220 SIDEKICK EZ FRAME External Fixation SystemWrightmedicaltechnologyinc · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K043289	E-Z Frame External Surgical Support Boot	Signal Medical Corp.	2005	—
−1	K130044	Sidekick EZ Frame External Fixation System	Wrightmedicaltechnologyinc	2013	—
0 (this device)	K143220	SIDEKICK EZ FRAME External Fixation System	Wrightmedicaltechnologyinc	2015	—

FIG. 1 — Lineage of K143220, 2005–2015Source: 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 21.3 · 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
*	K130044	Sidekick EZ Frame External Fixation System Summary page 4 …nce: 21 CFR 888.3030 – Class II Device Product Code, Device Panel: KTT, Orthopedic (a)(3). Predicate Devices: K130044: SIDEKICK® EZ FRAME™ External Fixation System (a)(4). Device Description…	Wrightmedicaltechnologyinc	2013	—

Also cleared against K130044: 3 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?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K130044.

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. 2015, 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?

Wright’s SIDEKICK® EZ FRAME™ External Fixation System is intended for:

• Triple Arthrodesis

• Isolated Rearfoot Arthrodesis

• Midfoot Arthrodesis

• Comminuted Trauma

• Diabetic Charcot Reconstruction

• Most foot pathology not requiring fixation above the ankle

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K143220 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143220: SIDEKICK EZ FRAME 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/K143220

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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