510(k) · Cleared
ClearedGalaxy UNYCO System
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 Oct 12, 2017 as substantially equivalent to K082650 (Synthes (Usa), 2008) and 1 other predicate after a 268-day review. Its family tree reaches back 5 generations to 1983.
- Decided
- Oct 12, 2017
- Review
- 268 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K831576 (1983). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 4 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- 3 generations backK113770 Orthofix Galaxy Fixation SystemOrthofix Srl · 2012 · Recalled
- 2 generations backK142052 Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl · 2014 · Recalled
- 1 generation backK153233 Galaxy UNYCO SystemOrthofix Srl · 2016 · Recalled
- This deviceK170146 Galaxy UNYCO SystemOrthofix Srl · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −4 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| −3 | K113770 | Orthofix Galaxy Fixation System | Orthofix Srl | 2012 | 13 |
| −2 | K142052 | Orthofix Galaxy Unyco Diaphyseal Tibia Kit | Orthofix Srl | 2014 | 1 |
| −1 | K153233 | Galaxy UNYCO System | Orthofix Srl | 2016 | 1 |
| 0 (this device) | 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 |
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 21.4 · 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? (2)
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…Product Code KTT Predicate Device Name 510(k) Number Manufacturer Synthes Large External Fixation, MR Conditional K082650 Synthes Galaxy Unyco System K153233 Orthofix Srl Description… | 2008 |
| * | K153233 | Galaxy UNYCO SystemSummary page 4…) Number Manufacturer Synthes Large External Fixation, MR Conditional K082650 Synthes Galaxy Unyco System K153233 Orthofix Srl Description The Galaxy UNYCO System consists of a series of sterile kits that… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 6 of the 14 ancestors have a recall of any class.
- 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. 2017, 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 System is intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment. Temporary stabilization of the femur, tibia and ankle in conditions and procedures, such as: • comminuted open or closed fractures • polytrauma patient • damage control orthopedics for fractures with severe soft tissue injuries • peri-prosthetic or peri-implant fractures • joint dislocations…
Read the full statement (99 words)
The Galaxy UNYCO System is intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
Temporary stabilization of the femur, tibia and ankle in conditions and procedures, such as:
• comminuted open or closed fractures
• polytrauma patient
• damage control orthopedics for fractures with severe soft tissue injuries
• peri-prosthetic or peri-implant fractures
• joint dislocations, intra- and extra-articular injuries where spanning fixation is needed
• intra-operative fracture reduction
• intermediate stabilization in staged surgery
• infected non-union pending second stage treatment bone-loss or other reconstructive procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170146 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170146: Galaxy UNYCO System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170146
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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