510(k) · Cleared
ClearedHoffmann II Mri External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on Jun 17, 2005 after a 29-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Jun 17, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- LXT
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK051306 Hoffmann II Mri External Fixation SystemHowmedica Osteonics Corp. · 2005
- Descendant · cites it directly · 13 of its ownK111786 Hoffmann 3 Modular External Fixation SystemStryker Corp. · 2012
- Descendant · cites it directly · 6 of its ownK122284 Hoffmann 3Stryker Corp. · 2012
- Descendant · 2 generations on · 6 of its ownK113770 Orthofix Galaxy Fixation SystemOrthofix Srl · 2012 · Recalled
- Descendant · 2 generations on · 2 of its ownK142052 Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK153233 Galaxy UNYCO SystemOrthofix Srl · 2016 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K111786Hoffmann 3 Modular External Fixation SystemStryker Corp. · 2012 · cites it directly13descendants
- K122284Hoffmann 3Stryker Corp. · 2012 · cites it directly6descendants
- K113770Orthofix Galaxy Fixation SystemOrthofix Srl · 2012 · 2 generations on6descendants
- K142052Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl · 2014 · 2 generations on2descendants
- K153233Galaxy UNYCO SystemOrthofix Srl · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051306 | Hoffmann II Mri External Fixation System | Howmedica Osteonics Corp. | 2005 | — |
| +1 | K111786 | Hoffmann 3 Modular External Fixation System | Stryker Corp. | 2012 | — |
| +1 | K122284 | Hoffmann 3 | Stryker Corp. | 2012 | — |
| +2 | K113770 | Orthofix Galaxy Fixation System | Orthofix Srl | 2012 | 13 |
| +2 | K142052 | Orthofix Galaxy Unyco Diaphyseal Tibia Kit | Orthofix Srl | 2014 | 1 |
| +3 | K153233 | Galaxy UNYCO System | Orthofix Srl | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 4 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 LXT? 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 LXT device
- #1 K230067 Para-Fix External Fixation Systemscore 6.3 · 2 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Hoffmann® II External Fixation System Named without a submission number |
What descends from it? (14)
See all 143 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K111786 (Stryker Corp., 2012) has gone furthest, with 13 descendants of its own.
How does its category compare?
All LXT devicesLXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LXT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LXT
Too few LXT 510(k)s in any year since 2007 to give a median.
Recalls per year · LXT
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXT
7in 2025
MAUDE reports naming product code LXT, 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 | 1 | — | 1 | 26 |
| 2008 | 1 | — | 0 | 58 |
| 2009 | 1 | — | 7 | 41 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 1 | — | 0 | 85 |
| 2012 | 0 | — | 0 | 42 |
| 2013 | 2 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 35 |
| 2016 | 0 | — | 0 | 38 |
| 2017 | 0 | — | 0 | 66 |
| 2018 | 0 | — | 2 | 73 |
| 2019 | 0 | — | 0 | 40 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 21 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 27 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Hoffmann® II MRI components are external fixation frame components for use with the components of the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Monotube® TRIAX T External Fixation System and in conjunction with Apex® Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051306: Hoffmann II Mri External 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/K051306
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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