510(k) · Cleared

Cleared

Practifix External Fixation System

K960014510(k) TraditionalCleared Mar 18, 199676-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

Orthopaedic Innovations, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Mar 18, 1996 after a 76-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Mar 18, 1996
Review: 76 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK960014 Practifix External Fixation SystemOrthopaedic Innovations, Inc. · 1996
Descendant · cites it directly · 1 of its ownK983881 Cobra External FixatorOrthopaedic Innovations, Inc. · 1998
Descendant · 2 generations on · 0 of its ownK012078 RadiofixFixano SA · 2001

Most influential descendants

Showing 2 of 2 · See all

K983881Cobra External FixatorOrthopaedic Innovations, Inc. · 1998 · cites it directly1descendant
K012078RadiofixFixano SA · 2001 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K960014	Practifix External Fixation System	Orthopaedic Innovations, Inc.	1996	—
+1	K983881	Cobra External Fixator	Orthopaedic Innovations, Inc.	1998	—
+2	K012078	Radiofix	Fixano SA	2001	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2001	1	0

FIG. 1 — Lineage of K960014, 1996–2001Source: 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? (3)

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	Recalls
*	—	Hex-Fix External Fixation by Smith and Nephew Richards Named without a submission number	—
*	—	Day External Fixation by DePuy Named without a submission number	—
*	—	AP/ASIF External Fixation System by Synthes Named without a submission number	—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K983881	Cobra External Fixator	Orthopaedic Innovations, Inc.	1998	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?

Of its descendants, K983881 (Orthopaedic Innovations, Inc., 1998) has gone furthest, with 1 descendant of its own.

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.

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?

Indications for use include: fracture fixation(open and closed); pseudarthrosis or long bones (both congenital and acquired); limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of osteotomies; and correction of bony or soft tissue defects.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K960014 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960014: Practifix 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/K960014

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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