510(k) · Cleared

Cleared

Traumafix (TM) External Fixator

K914558510(k) TraditionalCleared Jan 16, 199293-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

Synthes (Usa) · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Jan 16, 1992 after a 93-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.

Decided: Jan 16, 1992
Review: 93 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 0

29 later devices descend from it, 3 citing it directly.

This deviceK914558 Traumafix (TM) External FixatorSynthes (Usa) · 1992
Descendant · cites it directly · 23 of its ownK960297 Mandibular Bone Distractor IIHowmedica Corp. · 1996
Descendant · cites it directly · 17 of its ownK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
Descendant · 2 generations on · 11 of its ownK972166 Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
Descendant · 2 generations on · 8 of its ownK972154 Cohen DistractorHowmedica Leibinger, Inc. · 1997
Descendant · 2 generations on · 7 of its ownK990944 Osteomed Intraoral Distraction SystemOsteomed Corp. · 1999

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

1996high 4 (1997) · low 0 (2000)2026

Most influential descendants

Showing 5 of 29 · See all

K960297Mandibular Bone Distractor IIHowmedica Corp. · 1996 · cites it directly23descendants
K964649Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997 · cites it directly17descendants
K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997 · 2 generations on11descendants
K972154Cohen DistractorHowmedica Leibinger, Inc. · 1997 · 2 generations on8descendants
K990944Osteomed Intraoral Distraction SystemOsteomed Corp. · 1999 · 2 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K914558	Traumafix (TM) External Fixator	Synthes (Usa)	1992	—
+1	K960297	Mandibular Bone Distractor II	Howmedica Corp.	1996	—
+1	K964649	Vazquez Diner Intraoral Distraction Device	Howmedica Leibinger, Inc.	1997	—
+2	K972166	Guerrero - Bell Distractor	Howmedica Leibinger, Inc.	1997	—
+2	K972154	Cohen Distractor	Howmedica Leibinger, Inc.	1997	—
+2	K990944	Osteomed Intraoral Distraction System	Osteomed Corp.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	4	0
1998	2	0
1999	2	0
2002	2	0
2003	2	0
2004	1	0
2005	1	0
2006	1	0
2007	1	0
2010	1	0
2012	1	0
2013	2	0
2014	3	0
2017	1	0
2018	1	0
2019	1	0
2023	2	0

FIG. 1 — Lineage of K914558, 1992–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (29)

See all 29

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K960297	Mandibular Bone Distractor II	Howmedica Corp.	1996	23
K964649	Vazquez Diner Intraoral Distraction Device	Howmedica Leibinger, Inc.	1997	17
K122455	Synthes Small External Fixation System, Synthes Large External Fixation System	Synthes	2013	3

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, K960297 (Howmedica Corp., 1996) has gone furthest, with 23 descendants 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	—

https://510kreport.com/device/K914558 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914558: Traumafix (TM) External Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914558

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026