510(k) · Cleared

Recalled · Class II · 2018

Orthofix Galaxy Wrist

K141760510(k) TraditionalCleared Dec 8, 2014160-day reviewClass II21 CFR 888.3030Recalls 1

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

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

Cleared on Dec 8, 2014 as substantially equivalent to K963618 (Synthes (Usa), 1996) and 3 other predicates after a 160-day review. Its family tree reaches back 3 generations to 1983. It has been recalled once.

Decided: Dec 8, 2014
Review: 160 days
Class: Class II
Product code: KTT
Recalls: 1
Predicates: 4

Its longest line of descent runs back 3 generations to K831576 (1983). 12 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
2 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
1 generation backK113770 Orthofix Galaxy Fixation SystemOrthofix Srl · 2012 · Recalled
This deviceK141760 Orthofix Galaxy WristOrthofix Srl · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K831576	Orthofix	Electro-Biology, Inc.	1983	—
−2	K955848	Orthofix Modulsystem	Orthofix, Inc.	1996	23
−1	K113770	Orthofix Galaxy Fixation System	Orthofix Srl	2012	13
0 (this device)	K141760	Orthofix Galaxy Wrist	Orthofix Srl	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0
2005	2	0
2006	1	0
2008	2	0
2010	1	0
2012	1	0

FIG. 1 — Lineage of K141760, 1983–2014Source: 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? (4)

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
*	K963618	Synthes Simple Small External Fixator (Ssef) Summary page 4 …s II Regulation Number 21 CFR 888.3030 Product Code KTT Device Name 510(k) Number Manufacturer Synthes Small External K963618 Synthes Fixation System Stryker Hoffmann II MRI K053038 Stryker Compact External Fixation Syst…	Synthes (Usa)	1996	—
*	K053038	Hoffmann II Compact Mri External Fixation System Summary page 4 …ame 510(k) Number Manufacturer Synthes Small External K963618 Synthes Fixation System Stryker Hoffmann II MRI K053038 Stryker Compact External Fixation System Orthofix Penning Dynamic K955848 Orthofix Wrist Fixato…	Howmedica Osteonics Corp.	2005	—
*	K955848	Orthofix Modulsystem Summary page 4 …3618 Synthes Fixation System Stryker Hoffmann II MRI K053038 Stryker Compact External Fixation System Orthofix Penning Dynamic K955848 Orthofix Wrist Fixator Orthofix Galaxy Fixation K113770 Orthofix system Description…	Orthofix, Inc.	1996	23
*	K113770	Orthofix Galaxy Fixation System Summary page 4 …53038 Stryker Compact External Fixation System Orthofix Penning Dynamic K955848 Orthofix Wrist Fixator Orthofix Galaxy Fixation K113770 Orthofix system Description The Orthofix Galaxy Wrist is a complimentary system for the current…	Orthofix Srl	2012	13

Also cleared against K963618: 2 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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 27, 2018	Class II	Z-0403-2020	Device Design	As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
4 of the 12 ancestors have a recall of any class.
2 other devices also cite its predicate K963618.

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. 2014, 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?

The Orthofix Galaxy Wrist external fixator is an orthopedic device intended to be used for bone stabilization in trauma and orthopedic procedures, both on adults and pediatric patients as required.

The indications for use include:

- intra-articular or extra-articular fractures and dislocations of the wrist with or without soft tissue damage:

- polytrauma;

- carpal dislocations;

- unreduced fractures following conservative treatment;

- bone-loss or other reconstructive procedures;

- infection.

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/K141760 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141760: Orthofix Galaxy Wrist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141760

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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