510(k) · Cleared

Cleared

Hoffmann II Micro External Fixation System

K042019510(k) TraditionalCleared Sep 24, 200459-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

Howmedica Osteonics Corp. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Sep 24, 2004 after a 59-day review. The FDA summary names no predicate by number. 2 later devices descend from it.

Decided: Sep 24, 2004
Review: 59 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 0

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

This deviceK042019 Hoffmann II Micro External Fixation SystemHowmedica Osteonics Corp. · 2004
Descendant · cites it directly · 1 of its ownK141912 Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone…Advanced Orthopaedic Solutions, Inc. · 2014
Descendant · 2 generations on · 0 of its ownK232897 Arthrex Small External Fixation SystemArthrex, Inc. · 2023

Most influential descendants

Showing 2 of 2 · See all

K141912Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…Advanced Orthopaedic Solutions, Inc. · 2014 · cites it directly1descendant
K232897Arthrex Small External Fixation SystemArthrex, Inc. · 2023 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K042019	Hoffmann II Micro External Fixation System	Howmedica Osteonics Corp.	2004	—
+1	K141912	Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External…	Advanced Orthopaedic Solutions, Inc.	2014	—
+2	K232897	Arthrex Small External Fixation System	Arthrex, Inc.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2023	1	0

FIG. 1 — Lineage of K042019, 2004–2023Source: 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?

The FDA summary names no predicate by 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
K141912	Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…	Advanced Orthopaedic Solutions, Inc.	2014	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, K141912 (Advanced Orthopaedic Solutions, Inc., 2014) 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?

The Hoffmann® II Micro External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:

* Bone fracture fixation

* Osteotomy

* Arthrodesis

* Correction of deformity

* Revision procedure where other treatments or devices have been unsuccessful

* Non-unions and delayed unions

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042019 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042019: Hoffmann II Micro 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/K042019

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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