510(k) · Cleared
ClearedVariax 2 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 Apr 17, 2014 as substantially equivalent to K132502 (Stryker Trauma AG, 2013) after a 21-day review. Its family tree reaches back 11 generations to 1979. 19 later devices descend from it.
- Decided
- Apr 17, 2014
- Review
- 21 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K792022 (1979). 98 ancestors in all. 19 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 7 generations between
- 3 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 2 generations backK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- 1 generation backK132502 Variax 2 SystemStryker Trauma AG · 2013
- This deviceK140769 Variax 2 SystemStryker Trauma AG · 2014
- Descendant · cites it directly · 13 of its ownK173135 VariAx 2 SystemStryker GmbH · 2017
- Descendant · 2 generations on · 12 of its ownK180500 VariAx 2 SystemStryker GmbH · 2018
- Descendant · 3 generations on · 10 of its ownK191412 VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH · 2019
- Descendant · 4 generations on · 4 of its ownK212581 VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH · 2022
- Descendant · cites it directly · 4 of its ownK162841 VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH · 2017
Show all 11 generations
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 10 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 9 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 8 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 7 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 6 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 5 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 4 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 3 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 2 generations backK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- 1 generation backK132502 Variax 2 SystemStryker Trauma AG · 2013
- This deviceK140769 Variax 2 SystemStryker Trauma AG · 2014
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K173135VariAx 2 SystemStryker GmbH · 2017 · cites it directly13descendants
- K180500VariAx 2 SystemStryker GmbH · 2018 · 2 generations on12descendants
- K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH · 2019 · 3 generations on10descendants
- K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH · 2022 · 4 generations on4descendants
- K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH · 2017 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −10 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −9 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −8 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −7 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −6 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −5 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −4 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −3 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| −2 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| −1 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
| 0 (this device) | K140769 | Variax 2 System | Stryker Trauma AG | 2014 | — |
| +1 | K173135 | VariAx 2 System | Stryker GmbH | 2017 | — |
| +2 | K180500 | VariAx 2 System | Stryker GmbH | 2018 | — |
| +3 | K191412 | VariAx 2 System, VariAx 2 Mini Fragment System | Stryker GmbH | 2019 | — |
| +4 | K212581 | VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System | Stryker GmbH | 2022 | — |
| +1 | K162841 | VariAx Distal Radius Plating System, VariAx 2 System | Stryker GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 9 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 7 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 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? (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 |
|---|---|---|---|
| * | K132502 | Variax 2 SystemSummary page 2…Normal bone density or osteopenic bone. Substantial Equivalency The subject device components are substantially equivalent to the previously cleared VariAx 2 System (K 132502) in regards to intended use, materials, and operational principles and similar with regard to design for use in for internal bone… | 2013 |
What descends from it? (19)
See all 194 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 35 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 16 of the 98 ancestors have a recall of any class.
- Of its descendants, K173135 (Stryker GmbH, 2017) has gone furthest, with 13 descendants of its own.
- 3 other devices also cite its predicate K132502.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for: * Internal fracture fixation; * Osteotomies; * Revision procedures such as non-unions or mal-unions; In addition, the following indications are specific to the devices listed below: * T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the…
Read the full statement (224 words)
The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for:
* Internal fracture fixation;
* Osteotomies;
* Revision procedures such as non-unions or mal-unions;
In addition, the following indications are specific to the devices listed below:
* T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the treatment of:
o Compression fractures;
o Intra-articular and extra-articular fractures;
o Displaced fractures;
o Reconstruction procedures;
* T8 2.1mm Screws: For use in small bones, including the Distal Radius as well as the fore, mid- and hind Foot and Ankle, in the treatment of:
o Intra-articular and extra-articular fractures of the Distal Radius,
o Displaced and compression fractures of the Distal Radius;
o Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle;
o Reconstruction procedures in the Foot & Anle and Distal Radius;
* TIO 3.5mmn and Ti0 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of:
o Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna;
* Single, segmental and comminuted fractures;
o Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle;
o Normal bone density or osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140769 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140769: Variax 2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140769
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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