510(k) · Cleared
Recalled · Class II · 2017Galaxy 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 Jan 6, 2016 as substantially equivalent to K082650 (Synthes (Usa), 2008) and 1 other predicate after a 58-day review. Its family tree reaches back 4 generations to 1983. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 6, 2016
- Review
- 58 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K831576 (1983). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 3 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- 2 generations backK113770 Orthofix Galaxy Fixation SystemOrthofix Srl · 2012 · Recalled
- 1 generation backK142052 Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl · 2014 · Recalled
- This deviceK153233 Galaxy UNYCO SystemOrthofix Srl · 2016
- Descendant · cites it directly · 0 of its ownK170146 Galaxy UNYCO SystemOrthofix Srl · 2017
Most influential descendants
Showing 1 of 1 · See all- K170146Galaxy UNYCO SystemOrthofix Srl · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −3 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| −2 | K113770 | Orthofix Galaxy Fixation System | Orthofix Srl | 2012 | 13 |
| −1 | K142052 | Orthofix Galaxy Unyco Diaphyseal Tibia Kit | Orthofix Srl | 2014 | 1 |
| 0 (this device) | K153233 | Galaxy UNYCO System | Orthofix Srl | 2016 | — |
| +1 | 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 |
|---|---|---|
| 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? (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…oduct Code KTT Predicate Device Name 510(k) Number Manufacturer Synthes Large External Fixation, MR Conditional K082650 Synthes Orthofix Galaxy Unyco Diaphyseal Tibia Kit K142052 Orthofix Srl Descriptio… | 2008 |
| * | K142052 | Orthofix Galaxy Unyco Diaphyseal Tibia KitSummary page 4…mber Manufacturer Synthes Large External Fixation, MR Conditional K082650 Synthes Orthofix Galaxy Unyco Diaphyseal Tibia Kit K142052 Orthofix Srl Description The Orthofix Galaxy UNYCO System consists of a series of sterile kits that… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170146 | Galaxy UNYCO System | 2017 | 0 |
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 33 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K170146 (Orthofix Srl, 2017) has gone furthest, with 0 descendants 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. 2016, 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 tibia and foot in conditions and procedures, such as: • comminuted open or closed tibial 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 (136 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 tibia and foot in conditions and procedures, such as:
• comminuted open or closed tibial 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
The Galaxy UNYCO System is compatible with Galaxy Fixation System and bicortical screws. Galaxy Fixation System and bicortical screws must be used when Galaxy UNYCO is not indicated or available.
The product is indicated for non-weight-bearing use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153233: Galaxy UNYCO System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153233
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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