510(k) · Cleared
ClearedVariAx 2 Distal Radius System, VariAx 2 Distal Ulna 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 Jan 19, 2022 as substantially equivalent to K133974 (Stryker Leibinger GmbH, 2014) and 3 other predicates after a 156-day review. Its family tree reaches back 15 generations to 1979. 4 later devices descend from it.
- Decided
- Jan 19, 2022
- Review
- 156 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K792022 (1979). 140 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 11 generations between
- 3 generations backK173135 VariAx 2 SystemStryker GmbH · 2017
- 2 generations backK180500 VariAx 2 SystemStryker GmbH · 2018
- 1 generation backK191412 VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH · 2019
- This deviceK212581 VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH · 2022
- Descendant · cites it directly · 2 of its ownK233919 VariAx 2 Distal Radius SystemStryker GmbH · 2024
- Descendant · 2 generations on · 1 of its ownK242343 BPS Wrist Fracture SystemOrthonovis, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK250620 KLS Martin Ixos SystemKLS Martin L.P. · 2025
- Descendant · 3 generations on · 0 of its ownK250498 BPS Wrist Fracture SystemOrthonovis, Inc. · 2025
Show all 15 generations
- Root · 15 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 14 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 13 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 12 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 11 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 10 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 9 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 8 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 7 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 6 generations backK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- 5 generations backK132502 Variax 2 SystemStryker Trauma AG · 2013
- 4 generations backK140769 Variax 2 SystemStryker Trauma AG · 2014
- 3 generations backK173135 VariAx 2 SystemStryker GmbH · 2017
- 2 generations backK180500 VariAx 2 SystemStryker GmbH · 2018
- 1 generation backK191412 VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH · 2019
- This deviceK212581 VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH · 2022
Most influential descendants
Showing 4 of 4 · See all- K233919VariAx 2 Distal Radius SystemStryker GmbH · 2024 · cites it directly2descendants
- K242343BPS Wrist Fracture SystemOrthonovis, Inc. · 2024 · 2 generations on1descendant
- K250620KLS Martin Ixos SystemKLS Martin L.P. · 2025 · cites it directly0descendants
- K250498BPS Wrist Fracture SystemOrthonovis, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −14 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −13 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −12 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −11 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −10 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −9 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −8 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −7 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| −6 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| −5 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
| −4 | K140769 | Variax 2 System | Stryker Trauma AG | 2014 | — |
| −3 | K173135 | VariAx 2 System | Stryker GmbH | 2017 | — |
| −2 | K180500 | VariAx 2 System | Stryker GmbH | 2018 | — |
| −1 | K191412 | VariAx 2 System, VariAx 2 Mini Fragment System | Stryker GmbH | 2019 | — |
| 0 (this device) | K212581 | VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System | Stryker GmbH | 2022 | — |
| +1 | K233919 | VariAx 2 Distal Radius System | Stryker GmbH | 2024 | — |
| +2 | K242343 | BPS Wrist Fracture System | Orthonovis, Inc. | 2024 | — |
| +1 | K250620 | KLS Martin Ixos System | KLS Martin L.P. | 2025 | — |
| +3 | K250498 | BPS Wrist Fracture System | Orthonovis, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 12 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 12 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 9 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K133974 | Variax Distal Radius Plating SystemSummary page 5…JAN 19, 2022 Predicate Device: Primary Predicate: VariAx Distal Radius Plating System Line Extension (K133974) Additional Predicate Devices: VariAx 2 Mini Fragment & VariAx 2 System… | 2014 |
| * | K191412 | VariAx 2 System, VariAx 2 Mini Fragment SystemSummary page 5…(K133974) Additional Predicate Devices: VariAx 2 Mini Fragment & VariAx 2 System (K191412), TriMed Wrist Fixation System (K060041), LCP Distal Ulna Plate (K063049) Device Descr… | 2019 |
| * | K060041 | Trimed Bone PlatesSummary page 5…Additional Predicate Devices: VariAx 2 Mini Fragment & VariAx 2 System (K191412), TriMed Wrist Fixation System (K060041), LCP Distal Ulna Plate (K063049) Device Description: The distal ra… | 2006 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 5…VariAx 2 System (K191412), TriMed Wrist Fixation System (K060041), LCP Distal Ulna Plate (K063049) Device Description: The distal radius plates consist of an anatomically shaped Dorsal DR Plate… | 2006 |
What descends from it? (4)
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 43 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
- 27 of the 140 ancestors have a recall of any class.
- Of its descendants, K233919 (Stryker GmbH, 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K133974.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 VariAx 2 Distal Radius System is indicated for the fixation of fractures, osteotomies, nonunions, and malunions of the bones of the hand and wrist, including osteopenic bone.
The VariAx 2 Distal Ulna System is indicated for the fixation of fractures, osteotomies, nonunions, and malunions of the wrist, including osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212581: VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212581
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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