510(k) · Cleared
ClearedVariAx 2 One-Third Tubular Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker GmbH · HRS Plate, Fixation, Bone
Cleared on Aug 6, 2015 as substantially equivalent to K141204 (Stryker Trauma AG, 2014) after a 28-day review. Its family tree reaches back 3 generations to 2000. 6 later devices descend from it.
- Decided
- Aug 6, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000684 (2000). 4 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 2 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 1 generation backK141204 Variax 2 One Third Tubular Plating SystemStryker Trauma AG · 2014
- This deviceK151879 VariAx 2 One-Third Tubular Plating SystemStryker GmbH · 2015
- Descendant · cites it directly · 4 of its ownK231262 Pangea Femur Plating System, Pangea Fibula Plating System, Pangea…Stryker GmbH · 2023
- Descendant · 2 generations on · 2 of its ownK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
- Descendant · 2 generations on · 1 of its ownK253640 T2 Alpha Femur Retrograde Nailing System; Pangea Femur…Stryker GmbH · 2026
- Descendant · cites it directly · 1 of its ownK231257 Pangea Utility Plating System, Pangea PlatformStryker GmbH · 2023
- Descendant · 3 generations on · 0 of its ownK261481 Pangea Femur Reconstruction SystemStryker GmbH · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH · 2023 · cites it directly4descendants
- K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025 · 2 generations on2descendants
- K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH · 2026 · 2 generations on1descendant
- K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH · 2023 · cites it directly1descendant
- K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −2 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −1 | K141204 | Variax 2 One Third Tubular Plating System | Stryker Trauma AG | 2014 | — |
| 0 (this device) | K151879 | VariAx 2 One-Third Tubular Plating System | Stryker GmbH | 2015 | — |
| +1 | K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia… | Stryker GmbH | 2023 | — |
| +2 | K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025 | — |
| +2 | K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | 2026 | — |
| +1 | K231257 | Pangea Utility Plating System, Pangea Platform | Stryker GmbH | 2023 | — |
| +3 | K261481 | Pangea Femur Reconstruction System | Stryker GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K141204 | Variax 2 One Third Tubular Plating SystemSummary page 4…n This Special 510(k) submission is being supplied to the U.S. FDA seeking clearance for a device modification of VariAx 2 One-Third Tubular Plates previously cleared in K141204 (VariAx 2 One-Third Tubular Plating System). Modification includes a change of plate thickness and addition of grooves to the wai… | 2014 |
What descends from it? (6)
2 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 15 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K231262 (Stryker GmbH, 2023) has gone furthest, with 4 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. 2015, 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?
The Stryker VariAx 2 One-Third Tubular Plating System i1s intended for internal fixation of fractures of the clavicle,
scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in
adult patients.
Indications include the following:
» osteotomies, and non-unions
» fixation of fractures
» normal bone density and osteopenic bone
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151879 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151879: VariAx 2 One-Third Tubular Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151879
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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