510(k) · Cleared
ClearedHoffmann 3 Modular External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jan 26, 2012 as substantially equivalent to K051306 (Howmedica Osteonics Corp., 2005) and 2 other predicates after a 216-day review. Its family tree reaches back 1 generation to 2005. 13 later devices descend from it.
- Decided
- Jan 26, 2012
- Review
- 216 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K051306 (2005). 3 ancestors in all. 13 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK051306 Hoffmann II Mri External Fixation SystemHowmedica Osteonics Corp. · 2005
- This deviceK111786 Hoffmann 3 Modular External Fixation SystemStryker Corp. · 2012
- Descendant · cites it directly · 6 of its ownK122284 Hoffmann 3Stryker Corp. · 2012
- Descendant · cites it directly · 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
- Descendant · cites it directly · 1 of its ownK121252 Hoffmann 3 Modular External Fixation SystemStryker Corp. · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K122284Hoffmann 3Stryker Corp. · 2012 · cites it directly6descendants
- K113770Orthofix Galaxy Fixation SystemOrthofix Srl · 2012 · cites it directly6descendants
- K142052Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl · 2014 · 2 generations on2descendants
- K153233Galaxy UNYCO SystemOrthofix Srl · 2016 · 3 generations on1descendant
- K121252Hoffmann 3 Modular External Fixation SystemStryker Corp. · 2012 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051306 | Hoffmann II Mri External Fixation System | Howmedica Osteonics Corp. | 2005 | — |
| 0 (this device) | K111786 | Hoffmann 3 Modular External Fixation System | Stryker Corp. | 2012 | — |
| +1 | K122284 | Hoffmann 3 | Stryker Corp. | 2012 | — |
| +1 | 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 |
| +1 | K121252 | Hoffmann 3 Modular External Fixation System | Stryker Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 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 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 |
|---|---|---|---|
| * | K051306 | Hoffmann II Mri External Fixation SystemSummary page 3…sed device is substantially equivalent in intended, use, materials and performance characteristics to the Hoffmann 11 MRI System, predicate device, previously cleared in K051306, K053038, and K053472. The subject Hoffmann 3 Modular External Fixation System components share the same intended use and basic d… | 2005 |
| * | K053038 | Hoffmann II Compact Mri External Fixation SystemSummary page 3…e is substantially equivalent in intended, use, materials and performance characteristics to the Hoffmann 11 MRI System, predicate device, previously cleared in K051306, K053038, and K053472. The subject Hoffmann 3 Modular External Fixation System components share the same intended use and basic design con… | 2005 |
| * | K053472 | Hoffmann II Mri External Fixation SystemSummary page 3…ially equivalent in intended, use, materials and performance characteristics to the Hoffmann 11 MRI System, predicate device, previously cleared in K051306, K053038, and K053472. The subject Hoffmann 3 Modular External Fixation System components share the same intended use and basic design concepts as that… | 2006 |
What descends from it? (13)
See all 135 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?
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 Hoffmann 3 Modular External Fixation System components are external fixation frame components for use with the components of the Hoffmann 11 MRI and Hoffmann 11 Compact MRI External Fixation Systems, 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 rods, casts or other means of internal fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111786 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111786: Hoffmann 3 Modular 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/K111786
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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