510(k) · Cleared
Recalled · Class II · 2026Modification to Hoffmann II Micro 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 20, 2004 after a 78-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 7 times.
- Decided
- Jan 20, 2004
- Review
- 78 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 7
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK033476 Modification to Hoffmann II Micro External Fixation SystemHowmedica Osteonics Corp. · 2004
- Descendant · cites it directly · 0 of its ownK122777 NBX - Non Bridging External Fixator HandNutek Orthopaedics, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K122777NBX - Non Bridging External Fixator HandNutek Orthopaedics, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033476 | Modification to Hoffmann II Micro External Fixation System | Howmedica Osteonics Corp. | 2004 | — |
| +1 | K122777 | NBX - Non Bridging External Fixator Hand | Nutek Orthopaedics, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 Micro External Fixation System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122777 | NBX - Non Bridging External Fixator Hand | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 1, 2026 | Class II | Z-2830-2026 | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. |
| Jul 1, 2026 | Class II | Z-2832-2026 | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. |
| Jul 1, 2026 | Class II | Z-2833-2026 | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. |
| Jul 1, 2026 | Class II | Z-2827-2026 | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. |
| Jul 1, 2026 | Class II | Z-2831-2026 | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. |
| Jul 1, 2026 | Class II | Z-2829-2026 | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. |
| Jul 1, 2026 | Class II | Z-2828-2026 | Device Design | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K122777 (Nutek Orthopaedics, Inc., 2013) has gone furthest, with 0 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® I Micro External Fixation System is an intended to be used with the Half Pins or Transfixing Pins of the Hoffinann® 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 precludes 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/K033476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033476: Modification to Hoffmann II Micro 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/K033476
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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