510(k) · Cleared
ClearedVariax Distal Radius Torx Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HRS Plate, Fixation, Bone
Cleared on Mar 19, 2008 after a 9-day review. The FDA summary names its predicate without a number. 22 later devices descend from it.
- Decided
- Mar 19, 2008
- Review
- 9 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 1 citing it directly.
- This deviceK080667 Variax Distal Radius Torx ScrewsHowmedica Osteonics Corp. · 2008
- Descendant · cites it directly · 21 of its ownK132502 Variax 2 SystemStryker Trauma AG · 2013
- Descendant · 2 generations on · 19 of its ownK140769 Variax 2 SystemStryker Trauma AG · 2014
- Descendant · 3 generations on · 13 of its ownK173135 VariAx 2 SystemStryker GmbH · 2017
- Descendant · 4 generations on · 12 of its ownK180500 VariAx 2 SystemStryker GmbH · 2018
- Descendant · 5 generations on · 10 of its ownK191412 VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH · 2019
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K132502Variax 2 SystemStryker Trauma AG · 2013 · cites it directly21descendants
- K140769Variax 2 SystemStryker Trauma AG · 2014 · 2 generations on19descendants
- K173135VariAx 2 SystemStryker GmbH · 2017 · 3 generations on13descendants
- K180500VariAx 2 SystemStryker GmbH · 2018 · 4 generations on12descendants
- K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH · 2019 · 5 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080667 | Variax Distal Radius Torx Screws | Howmedica Osteonics Corp. | 2008 | — |
| +1 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
| +2 | K140769 | Variax 2 System | Stryker Trauma AG | 2014 | — |
| +3 | K173135 | VariAx 2 System | Stryker GmbH | 2017 | — |
| +4 | K180500 | VariAx 2 System | Stryker GmbH | 2018 | — |
| +5 | K191412 | VariAx 2 System, VariAx 2 Mini Fragment System | Stryker GmbH | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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 |
|---|---|---|---|
| * | — | Stryker Leibinger Universal Distal Radius System Named without a submission number | |
| * | — | Stryker Foot System Named without a submission number |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132502 | Variax 2 System | 2013 | 21 |
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, K132502 (Stryker Trauma AG, 2013) has gone furthest, with 21 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
Stryker® Leibinger Universal Distal Radius System is intended for use in internal fixation
of the small bone fractures, primarily including distal radius fractures. Examples of these
distal radius fractures include compression fractures, intra-articular and extra-articular
fractures, displaced fractures and surgical reduction. This system can be used for palmar,
dorsal, or orthogonal application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080667 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080667: Variax Distal Radius Torx Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080667
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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