510(k) · Cleared
Recalled · Class II · 2013Variax 2 Compression Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Trauma AG · HRS Plate, Fixation, Bone
Cleared on Mar 22, 2013 as substantially equivalent to K000684 (Synthes (Usa), 2000) and 1 other predicate after a 79-day review. Its family tree reaches back 4 generations to 1998. 27 later devices descend from it. It has been recalled once.
- Decided
- Mar 22, 2013
- Review
- 79 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K981372 (1998). 12 ancestors in all. 27 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 3 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 2 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 1 generation backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- This deviceK130009 Variax 2 Compression Plating SystemStryker Trauma AG · 2013
- 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 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · 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 |
|---|---|---|---|---|---|
| −4 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −3 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −2 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −1 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| 0 (this device) | K130009 | Variax 2 Compression Plating System | Stryker Trauma AG | 2013 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 2…rison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the following predicate device: " K000684 Small Fragment Dynamic Compression Locking (DCL) System * K082807- SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION… | 2000 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 2…nded use, materials and performance characteristics to the following predicate device: " K000684 Small Fragment Dynamic Compression Locking (DCL) System * K082807- SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS Non-Clinical Testing Non-clini… | 2008 |
What descends from it? (27)
See all 273 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2013 | Class II | Z-1507-2016 | Device Design | Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole. |
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 4.5 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K132502 (Stryker Trauma AG, 2013) has gone furthest, with 21 descendants of its own.
- 68 other devices also cite its predicate K000684.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula for the following indications:
" osteotomies, mat-unions, and non-unions
* single, segmental, and comminuted fractures
normal bone density and osteopenic bone
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130009: Variax 2 Compression 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/K130009
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