510(k) · Cleared
Recalled · Class II · 2017Orthofix Galaxy Unyco Diaphyseal Tibia Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix Srl · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Dec 5, 2014 as substantially equivalent to K082650 (Synthes (Usa), 2008) and 2 other predicates after a 130-day review. Its family tree reaches back 3 generations to 1983. 2 later devices descend from it. It has been recalled once.
- Decided
- Dec 5, 2014
- Review
- 130 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K831576 (1983). 12 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- 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 deviceK142052 Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl · 2014
- Descendant · cites it directly · 1 of its ownK153233 Galaxy UNYCO SystemOrthofix Srl · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK170146 Galaxy UNYCO SystemOrthofix Srl · 2017
Most influential descendants
Showing 2 of 2 · See allView 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) | K142052 | Orthofix Galaxy Unyco Diaphyseal Tibia Kit | Orthofix Srl | 2014 | — |
| +1 | K153233 | Galaxy UNYCO System | Orthofix Srl | 2016 | 1 |
| +2 | K170146 | Galaxy UNYCO System | Orthofix Srl | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K082650 | Synthes Large External Fixation, MR ConditionalSummary page 4…roduct Code KTT Device Name 510(k) Number Manufacturer Synthes Large External Fixation, MR Conditional K082650 Synthes Orthofix Galaxy Fixation K113770 Orthofix Srl Hoffmann 3 Ext… | 2008 |
| * | K113770 | Orthofix Galaxy Fixation SystemSummary page 4…Number Manufacturer Synthes Large External Fixation, MR Conditional K082650 Synthes Orthofix Galaxy Fixation K113770 Orthofix Srl Hoffmann 3 External Fixation System K122284 Stryker Description… | 2012 |
| * | K122284 | Hoffmann 3Summary page 4…Synthes Orthofix Galaxy Fixation K113770 Orthofix Srl Hoffmann 3 External Fixation System K122284 Stryker Description The Orthofix Galaxy UNYCO Diaphyseal Tibia Kit consists of a series of… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153233 | Galaxy UNYCO System | 2016 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 5, 2017 | Class II | Z-0291-2018 | Process change control | The power drill torque limiter may break during use in surgery application. |
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.
- Of its descendants, K153233 (Orthofix Srl, 2016) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K082650.
How does its category compare?
All KTT devicesKTT 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
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 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 Galaxy UNYCO Diaphyseal Tibia Kit is intended to be used to provide treatment for bone stabilization in trauma, specifically lower limb fractures that require temporary fixation prior to definitive fixation. The Galaxy UNYCO Diaphyseal Tibia Kit is indicated to be used for temporary stabilization of tibial fractures in trauma procedures (damage control orthopaedics prior to definitive treatment). The product is indicated for non-weight-bearing use.…
Read the full statement (115 words)
The Galaxy UNYCO Diaphyseal Tibia Kit is intended to be used to provide treatment for bone stabilization in trauma,
specifically lower limb fractures that require temporary fixation prior to definitive fixation.
The Galaxy UNYCO Diaphyseal Tibia Kit is indicated to be used for temporary stabilization of tibial fractures in trauma
procedures (damage control orthopaedics prior to definitive treatment). The product is indicated for non-weight-bearing
use. The indications for use include:
• Tibial fractures extending from about 8cm below the knee to about 7 cm above the ankle joint, including comminuted
open or closed tibial fractures and polytrauma.
• Temporary stabilisation of the tibia after debridement for osteomyelitis or an infected non-union pending second stage
treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142052: Orthofix Galaxy Unyco Diaphyseal Tibia Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142052
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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