510(k) · Cleared
ClearedHoffmann 3
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 Oct 24, 2012 as substantially equivalent to K111786 (Stryker Corp., 2012) and 2 other predicates after an 86-day review. Its family tree reaches back 2 generations to 2005. 6 later devices descend from it.
- Decided
- Oct 24, 2012
- Review
- 86 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K051306 (2005). 4 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK051306 Hoffmann II Mri External Fixation SystemHowmedica Osteonics Corp. · 2005
- 1 generation backK111786 Hoffmann 3 Modular External Fixation SystemStryker Corp. · 2012
- This deviceK122284 Hoffmann 3Stryker Corp. · 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 ownK182285 PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK173883 External Fixation SystemLife Spine, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK172438 ARBOR External Fixation SystemGlobus Medical, Inc. · 2018
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
- K182285PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd. · 2019 · cites it directly0descendants
- K173883External Fixation SystemLife Spine, Inc. · 2018 · cites it directly0descendants
- K172438ARBOR External Fixation SystemGlobus Medical, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051306 | Hoffmann II Mri External Fixation System | Howmedica Osteonics Corp. | 2005 | — |
| −1 | K111786 | Hoffmann 3 Modular External Fixation System | Stryker Corp. | 2012 | — |
| 0 (this device) | K122284 | Hoffmann 3 | Stryker Corp. | 2012 | — |
| +1 | K142052 | Orthofix Galaxy Unyco Diaphyseal Tibia Kit | Orthofix Srl | 2014 | 1 |
| +2 | K153233 | Galaxy UNYCO System | Orthofix Srl | 2016 | 1 |
| +1 | K182285 | PK High Tibial Osteotomy Correction System | Paonan Biotech Co., Ltd. | 2019 | — |
| +1 | K173883 | External Fixation System | Life Spine, Inc. | 2018 | — |
| +1 | K172438 | ARBOR External Fixation System | Globus Medical, Inc. | 2018 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 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 21.4 · 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? (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 |
|---|---|---|---|
| * | K111786 | Hoffmann 3 Modular External Fixation System | 2012 |
| * | K051306 | Hoffmann II Mri External Fixation SystemSummary page 2…valent in intended use, materials and performance characteristics to the following predicate devices: * Ki 11786 Hoffmann 3 Modular External Fixation System * K05 1306 Hoffmann 11 MRI External Fixation System * K053472 Hoffmann 11 MRI Components * K00 1886 Apex Fixation Pins (reference… | 2005 |
| * | K053472 | Hoffmann II Mri External Fixation SystemSummary page 2…eristics to the following predicate devices: * Ki 11786 Hoffmann 3 Modular External Fixation System * K05 1306 Hoffmann 11 MRI External Fixation System * K053472 Hoffmann 11 MRI Components * K00 1886 Apex Fixation Pins (reference predicate) Non-Clinical Testing: Non-clinical laborator… | 2006 |
| † | K001886 | Apex Fixation Pins | 2000 |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K142052 (Orthofix Srl, 2014) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K111786.
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 II MRI and Hoffmann II 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.
The indications for use of external fixation devices include:
* Bone fracture fixation
* Osteotomy
* Arthrodesis
* Correction of deformity
* Revision procedure where other treatments or devices have been unsuccessful
* Bone reconstruction procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122284 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122284: Hoffmann 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122284
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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