510(k) · Cleared
ClearedHoffmann II Foot Ring
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 Sep 8, 2004 after a 77-day review. The FDA summary names no predicate by number. 24 later devices descend from it.
- Decided
- Sep 8, 2004
- Review
- 77 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 2 citing it directly.
- This deviceK041706 Hoffmann II Foot RingHowmedica Osteonics Corp. · 2004
- Descendant · cites it directly · 17 of its ownK113327 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp. · 2012 · Recalled
- Descendant · 2 generations on · 15 of its ownK130907 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2013
- Descendant · 2 generations on · 15 of its ownK130334 Hoffmann LRF (Limb Reconstruction Frame System)Stryker Trauma AG · 2013
- Descendant · 2 generations on · 14 of its ownK140961 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2014
- Descendant · 3 generations on · 13 of its ownK153377 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH · 2016 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K113327Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp. · 2012 · cites it directly17descendants
- K130907Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2013 · 2 generations on15descendants
- K130334Hoffmann LRF (Limb Reconstruction Frame System)Stryker Trauma AG · 2013 · 2 generations on15descendants
- K140961Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2014 · 2 generations on14descendants
- K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH · 2016 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041706 | Hoffmann II Foot Ring | Howmedica Osteonics Corp. | 2004 | — |
| +1 | K113327 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker Corp. | 2012 | 3 |
| +2 | K130907 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker Trauma AG | 2013 | — |
| +2 | K130334 | Hoffmann LRF (Limb Reconstruction Frame System) | Stryker Trauma AG | 2013 | — |
| +2 | K140961 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker Trauma AG | 2014 | — |
| +3 | K153377 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker GmbH | 2016 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (24)
See all 242 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, K113327 (Stryker Corp., 2012) has gone furthest, with 17 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 Hybrid Frame System is intended for use to provide stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to: * Bone fracture fixation *…
Read the full statement (107 words)
The Hoffmann ® II Hybrid Frame System is intended for use to provide stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:
* Bone fracture fixation
* Osteotomy
* Arthrodesis
* Correction of deformity
* Revision procedure where other treatments or devices have been unsuccessful
* Bone reconstruction procedures
* Fusions and replantations of the foot
* Charcot foot reconstruction and Lisfranc dislocations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041706 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041706: Hoffmann II Foot Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041706
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