510(k) · Cleared
Recalled · Class II · 2026Orthofix Galaxy Fixation 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 Sep 4, 2012 as substantially equivalent to K082650 (Synthes (Usa), 2008) and 5 other predicates after a 257-day review. Its family tree reaches back 2 generations to 1983. 6 later devices descend from it. It has been recalled 13 times.
- Decided
- Sep 4, 2012
- Review
- 257 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 13
- Predicates
- 6
Its longest line of descent runs back 2 generations to K831576 (1983). 10 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 1 generation backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- This deviceK113770 Orthofix Galaxy Fixation SystemOrthofix Srl · 2012
- Descendant · cites it directly · 2 of its ownK142052 Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK153233 Galaxy UNYCO SystemOrthofix Srl · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK242452 Monkey Bars Pin to Bar External Fixation SystemParagon 28, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK200491 Bfix Orthopedic External Fixator SystemsAike (Shanghai) Medical Instrument Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK170146 Galaxy UNYCO SystemOrthofix Srl · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K142052Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl · 2014 · cites it directly2descendants
- K153233Galaxy UNYCO SystemOrthofix Srl · 2016 · 2 generations on1descendant
- K242452Monkey Bars Pin to Bar External Fixation SystemParagon 28, Inc. · 2024 · cites it directly0descendants
- K200491Bfix Orthopedic External Fixator SystemsAike (Shanghai) Medical Instrument Co., Ltd. · 2021 · cites it directly0descendants
- K170146Galaxy UNYCO SystemOrthofix Srl · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −1 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| 0 (this device) | K113770 | Orthofix Galaxy Fixation System | Orthofix Srl | 2012 | — |
| +1 | K142052 | Orthofix Galaxy Unyco Diaphyseal Tibia Kit | Orthofix Srl | 2014 | 1 |
| +2 | K153233 | Galaxy UNYCO System | Orthofix Srl | 2016 | 1 |
| +1 | K242452 | Monkey Bars Pin to Bar External Fixation System | Paragon 28, Inc. | 2024 | — |
| +1 | K200491 | Bfix Orthopedic External Fixator Systems | Aike (Shanghai) Medical Instrument Co., Ltd. | 2021 | — |
| +3 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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? (6)
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 1…lent in intended use, materials and technological characteristics to the following external fixation systems: " Synthes External Fixation Systems, cleared under K082650 and K090658 " Orthofix Dynamic Axial Fixation System, cleared under K955848 * Additional Accessories for the Orthofax Syste… | 2008 |
| * | K090658 | Synthes External Fixation Devices, MR ConditionalSummary page 1…nded use, materials and technological characteristics to the following external fixation systems: " Synthes External Fixation Systems, cleared under K082650 and K090658 " Orthofix Dynamic Axial Fixation System, cleared under K955848 * Additional Accessories for the Orthofax System, cleared u… | 2010 |
| * | K955848 | Orthofix ModulsystemSummary page 1…lowing external fixation systems: " Synthes External Fixation Systems, cleared under K082650 and K090658 " Orthofix Dynamic Axial Fixation System, cleared under K955848 * Additional Accessories for the Orthofax System, cleared under K944092 * Smith & Nephew Jet-X® Bar System Clamps, Bars and… | 1996 |
| * | K944092 | Additional Accessories for the Orthofix SystemSummary page 1…, cleared under K082650 and K090658 " Orthofix Dynamic Axial Fixation System, cleared under K955848 * Additional Accessories for the Orthofax System, cleared under K944092 * Smith & Nephew Jet-X® Bar System Clamps, Bars and Posts - MR Conditional, cleared under K072212 * Hoffmann 3 Modular… | 1995 |
| * | K072212 | Jet-X Bar System Clamps, Bars and Posts-MR SafeSummary page 1…* Additional Accessories for the Orthofax System, cleared under K944092 * Smith & Nephew Jet-X® Bar System Clamps, Bars and Posts - MR Conditional, cleared under K072212 * Hoffmann 3 Modular External Fixation System, cleared under Kil1786 4. Intended Use: The Orthofix Gal… | 2008 |
| * | K111786 | Hoffmann 3 Modular External Fixation System Cleared while this submission was under review Summary page 3…nal, cleared under K072212 and testing in a Magnetic Resonance Environment safely used in Magnetic Resonance Imaging, under predetermined conditions cleared in K111786 of H-offmann 3 Modular External Fixation System. The components included in the Orthofix Galaxy Fixation system and th… | 2012 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 10, 2026 | Class II | Z-2729-2026 | Process change control | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 |
| Jun 10, 2026 | Class II | Z-2731-2026 | Process change control | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 |
| Jun 10, 2026 | Class II | Z-2732-2026 | Process change control | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 |
| Jun 10, 2026 | Class II | Z-2730-2026 | Process change control | Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 |
| Sep 27, 2018 | Class II | Z-0396-2020 | 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. |
| Sep 27, 2018 | Class II | Z-0397-2020 | 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. |
| Sep 27, 2018 | Class II | Z-0398-2020 | 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. |
| Sep 27, 2018 | Class II | Z-0401-2020 | 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. |
| Sep 27, 2018 | Class II | Z-0402-2020 | 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. |
| Sep 27, 2018 | Class II | Z-0394-2020 | 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. |
| Sep 27, 2018 | Class II | Z-0395-2020 | 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. |
| Sep 27, 2018 | Class II | Z-0399-2020 | 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. |
| Sep 27, 2018 | Class II | Z-0400-2020 | 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. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 16.5 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K142052 (Orthofix Srl, 2014) has gone furthest, with 2 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. 2012, 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 Orthofix Galaxy Fixation System and is intended to be used for bone stabilization in trauma and orthopedic procedures, both on adults and all pediatric subgroups patients except newborns, as required. The indications for use include: - Open or closed fractures in long bones; - Vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures; - Infected and aseptic non-unions; - joint pathologies/injuries of upper…
Read the full statement (121 words)
The Orthofix Galaxy Fixation System and is intended to be used for bone stabilization in trauma and orthopedic procedures, both on adults and all pediatric subgroups patients except newborns, as required.
The indications for use include:
- Open or closed fractures in long bones;
- Vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures;
- Infected and aseptic non-unions;
- joint pathologies/injuries of upper and lower limbs such as:
* proximal humeral fractures;
* intra-articular knee, ankle and wrist fractures;
* Delayed treatment of dislocated and stiff elbows;
* Chronic, persistent elbow joint instability;
* Acute elbow joint instability after complex ligament injuries;
* Unstable elbow fractures;
* Additional elbow stabilization of post-operative unstable internal fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113770: Orthofix Galaxy 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/K113770
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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