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. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jan 11, 2006 after a 28-day review. The FDA summary names its predicate without a number. 31 later devices descend from it.
- Decided
- Jan 11, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 6 citing it directly.
- This deviceK053472 Hoffmann II Mri External Fixation SystemHowmedica Osteonics Corp. · 2006
- Descendant · cites it directly · 13 of its ownK111786 Hoffmann 3 Modular External Fixation SystemStryker Corp. · 2012
- Descendant · cites it directly · 11 of its ownK091258 Extrafix External Fixation SystemQfx Technologies, Inc. · 2009
- Descendant · cites it directly · 9 of its ownK111155 Xtrafix External Fixation SystemExtraortho, Inc. · 2011
- Descendant · 2 generations on · 8 of its ownK113383 Xtrafix External Fixation SystemExtraortho, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK122284 Hoffmann 3Stryker Corp. · 2012
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K111786Hoffmann 3 Modular External Fixation SystemStryker Corp. · 2012 · cites it directly13descendants
- K091258Extrafix External Fixation SystemQfx Technologies, Inc. · 2009 · cites it directly11descendants
- K111155Xtrafix External Fixation SystemExtraortho, Inc. · 2011 · cites it directly9descendants
- K113383Xtrafix External Fixation SystemExtraortho, Inc. · 2012 · 2 generations on8descendants
- K122284Hoffmann 3Stryker Corp. · 2012 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053472 | Hoffmann II Mri External Fixation System | Howmedica Osteonics Corp. | 2006 | — |
| +1 | K111786 | Hoffmann 3 Modular External Fixation System | Stryker Corp. | 2012 | — |
| +1 | K091258 | Extrafix External Fixation System | Qfx Technologies, Inc. | 2009 | — |
| +1 | K111155 | Xtrafix External Fixation System | Extraortho, Inc. | 2011 | — |
| +2 | K113383 | Xtrafix External Fixation System | Extraortho, Inc. | 2012 | — |
| +1 | K122284 | Hoffmann 3 | Stryker Corp. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 21.4 · 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 |
|---|---|---|---|
| * | — | Hoffmann II MRI External Fixation System Named without a submission number | |
| * | — | Hoffmann II External Fixation System Named without a submission number |
What descends from it? (31)
See all 316 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111786 | Hoffmann 3 Modular External Fixation System | 2012 | 13 |
| K091258 | Extrafix External Fixation System | 2009 | 11 |
| K111155 | Xtrafix External Fixation System | 2011 | 9 |
| K122284 | Hoffmann 3 | 2012 | 6 |
| K080408 | External Fixation Clamp 5.0 MM Pin X9.5MM Rod, Model 1151-100, External Fixaton Clamp… | 2008 | 2 |
| K181630 | Revolution External Plating System | 2019 | 1 |
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 MRI components are external fixation frame components for use with the components of the H1offinann® External Fixation System, I loffmann® I External Fixation System, Monotube® TRIAX TM 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/K053472 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053472: Hoffmann II Mri External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053472
Report an extraction error
Are you the manufacturer?
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