510(k) · Cleared
ClearedVariax Distal Fibula Plate
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 Jul 18, 2008 after a 73-day review. The FDA summary names its predicate without a number. 100 later devices descend from it.
- Decided
- Jul 18, 2008
- Review
- 73 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
100 later devices descend from it, 8 citing it directly.
- This deviceK081284 Variax Distal Fibula PlateHowmedica Osteonics Corp. · 2008
- Descendant · cites it directly · 77 of its ownK102282 The Varia Fibula Locked Plating System Line Extension Addition of…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010
- Descendant · 2 generations on · 54 of its ownK123000 Integra Total Foot SystemsIntegra LifeSciences Corporation · 2012
- Descendant · 3 generations on · 23 of its ownK132594 Crosscheck Plating SystemSolana Surgical, LLC · 2013 · Recalled
- Descendant · 4 generations on · 22 of its ownK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015
- Descendant · 3 generations on · 21 of its ownK163293 Colink™ Plating SystemIn2bones USA, LLC · 2017 · Recalled
Showing 5 of 100 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 100 · See all- K102282The Varia Fibula Locked Plating System Line Extension Addition of Straight PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010 · cites it directly77descendants
- K123000Integra Total Foot SystemsIntegra LifeSciences Corporation · 2012 · 2 generations on54descendants
- K132594Crosscheck Plating SystemSolana Surgical, LLC · 2013 · 3 generations on23descendants
- K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015 · 4 generations on22descendants
- K163293Colink™ Plating SystemIn2bones USA, LLC · 2017 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081284 | Variax Distal Fibula Plate | Howmedica Osteonics Corp. | 2008 | — |
| +1 | K102282 | The Varia Fibula Locked Plating System Line Extension Addition of Straight… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010 | — |
| +2 | K123000 | Integra Total Foot Systems | Integra LifeSciences Corporation | 2012 | — |
| +3 | K132594 | Crosscheck Plating System | Solana Surgical, LLC | 2013 | 21 |
| +4 | K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | Wrightmedicaltechnologyinc | 2015 | — |
| +3 | K163293 | Colink™ Plating System | In2bones USA, LLC | 2017 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 10 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 10 | 0 |
| 2021 | 9 | 0 |
| 2022 | 6 | 0 |
| 2023 | 11 | 0 |
| 2024 | 12 | 0 |
| 2025 | 7 | 0 |
| 2026 | 8 | 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? (4)
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 |
|---|---|---|---|
| * | — | Stryker® Foot Named without a submission number | |
| * | — | Profyle® Named without a submission number | |
| * | — | Universal Distal Radius System Named without a submission number | |
| * | — | Synthes® Small Fragment Locking Compression Plate (LCP) System Named without a submission number |
What descends from it? (100)
See all 1008 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102282 | The Varia Fibula Locked Plating System Line Extension Addition of Straight Plates | 2010 | 77 |
| K132502 | Variax 2 System | 2013 | 21 |
| K151886 | Acumed Ankle and Small Fragment Base Set Update | 2015 | 15 |
| K120409 | Piccolo Composite Plate System | 2012 | 11 |
| K152158 | ARIX Ankle System | 2015 | 6 |
| K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System… | 2023 | 4 |
| K231441 | ARIX Ankle System | 2023 | 0 |
| K170979 | ARIX Ankle Fibula Hook Plate System | 2017 | 0 |
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, K102282 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2010) has gone furthest, with 77 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. 2008, 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 VariAxTM Distal Lateral Fibula Plate is intended for use in internal fixation of the
distal fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081284 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081284: Variax Distal Fibula Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081284
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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