510(k) · Cleared
ClearedHoffmann II Compact Mri External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Nov 22, 2005 after a 26-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.
- Decided
- Nov 22, 2005
- Review
- 26 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 3 citing it directly.
- This deviceK053038 Hoffmann II Compact Mri External Fixation SystemHowmedica Osteonics Corp. · 2005
- Descendant · cites it directly · 13 of its ownK111786 Hoffmann 3 Modular External Fixation SystemStryker Corp. · 2012
- Descendant · 2 generations on · 6 of its ownK122284 Hoffmann 3Stryker Corp. · 2012
- Descendant · 2 generations on · 6 of its ownK113770 Orthofix Galaxy Fixation SystemOrthofix Srl · 2012 · Recalled
- Descendant · 3 generations on · 2 of its ownK142052 Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl · 2014 · Recalled
- Descendant · 4 generations on · 1 of its ownK153233 Galaxy UNYCO SystemOrthofix Srl · 2016 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K111786Hoffmann 3 Modular External Fixation SystemStryker Corp. · 2012 · cites it directly13descendants
- K122284Hoffmann 3Stryker Corp. · 2012 · 2 generations on6descendants
- K113770Orthofix Galaxy Fixation SystemOrthofix Srl · 2012 · 2 generations on6descendants
- K142052Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl · 2014 · 3 generations on2descendants
- K153233Galaxy UNYCO SystemOrthofix Srl · 2016 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053038 | Hoffmann II Compact Mri External Fixation System | Howmedica Osteonics Corp. | 2005 | — |
| +1 | K111786 | Hoffmann 3 Modular External Fixation System | Stryker Corp. | 2012 | — |
| +2 | K122284 | Hoffmann 3 | Stryker Corp. | 2012 | — |
| +2 | K113770 | Orthofix Galaxy Fixation System | Orthofix Srl | 2012 | 13 |
| +3 | K142052 | Orthofix Galaxy Unyco Diaphyseal Tibia Kit | Orthofix Srl | 2014 | 1 |
| +4 | K153233 | Galaxy UNYCO System | Orthofix Srl | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 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 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? (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 Compact External Fixation System Named without a submission number |
What descends from it? (16)
See all 163 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 KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 ® II Compact TM MRI components are intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting, and other means of internal fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053038: Hoffmann II Compact 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/K053038
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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