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 Oct 23, 2013 as substantially equivalent to K080667 (Howmedica Osteonics Corp., 2008) and 9 other predicates after a 75-day review. Its family tree reaches back 10 generations to 1979. 21 later devices descend from it.
- Decided
- Oct 23, 2013
- Review
- 75 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 10 generations to K792022 (1979). 97 ancestors in all. 21 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 6 generations between
- 3 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 2 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 1 generation backK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- This deviceK132502 Variax 2 SystemStryker Trauma AG · 2013
- Descendant · cites it directly · 19 of its ownK140769 Variax 2 SystemStryker Trauma AG · 2014
- Descendant · 2 generations on · 13 of its ownK173135 VariAx 2 SystemStryker GmbH · 2017
- Descendant · 3 generations on · 12 of its ownK180500 VariAx 2 SystemStryker GmbH · 2018
- Descendant · 4 generations on · 10 of its ownK191412 VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH · 2019
- Descendant · 5 generations on · 4 of its ownK212581 VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH · 2022
Show all 10 generations
- Root · 10 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 9 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 8 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 7 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 6 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 5 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 4 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 3 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 2 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 1 generation backK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- This deviceK132502 Variax 2 SystemStryker Trauma AG · 2013
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K140769Variax 2 SystemStryker Trauma AG · 2014 · cites it directly19descendants
- K173135VariAx 2 SystemStryker GmbH · 2017 · 2 generations on13descendants
- K180500VariAx 2 SystemStryker GmbH · 2018 · 3 generations on12descendants
- K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH · 2019 · 4 generations on10descendants
- K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH · 2022 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −9 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −8 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −7 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −6 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −5 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −4 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −3 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −2 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| −1 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| 0 (this device) | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
| +1 | K140769 | Variax 2 System | Stryker Trauma AG | 2014 | — |
| +2 | K173135 | VariAx 2 System | Stryker GmbH | 2017 | — |
| +3 | K180500 | VariAx 2 System | Stryker GmbH | 2018 | — |
| +4 | K191412 | VariAx 2 System, VariAx 2 Mini Fragment System | Stryker GmbH | 2019 | — |
| +5 | K212581 | VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System | Stryker GmbH | 2022 | — |
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 |
|---|---|---|
| 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? (10)
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 |
|---|---|---|---|
| * | K080667 | Variax Distal Radius Torx ScrewsSummary page 3…valent in intended use, materials and performance characteristics to the following predicate devices: Table 1: Predicate devices 510(k) N~umber*________________________ K080667 VariAx Distal Radius Tonx Screws K100271 VariAx Distal Radius Line Extension of XXL Plates K063875… | 2008 |
| * | K100271 | Vari AX Distal Radius Line Extensions of XXL PlatesSummary page 3…aracteristics to the following predicate devices: Table 1: Predicate devices 510(k) N~umber*________________________ K080667 VariAx Distal Radius Tonx Screws K100271 VariAx Distal Radius Line Extension of XXL Plates K063875 Stryker Foot Plating System K08 1284 Va… | 2010 |
| * | K063875 | Stryker Foot Plating SystemSummary page 3…devices 510(k) N~umber*________________________ K080667 VariAx Distal Radius Tonx Screws K100271 VariAx Distal Radius Line Extension of XXL Plates K063875 Stryker Foot Plating System K08 1284 VariAx Distal Fibula Plate K 102282 VariAx Locked Plating Sys… | 2007 |
| * | K081284 | Variax Distal Fibula PlateSummary page 3…K080667 VariAx Distal Radius Tonx Screws K100271 VariAx Distal Radius Line Extension of XXL Plates K063875 Stryker Foot Plating System K08 1284 VariAx Distal Fibula Plate K 102282 VariAx Locked Plating System Line Extension for Addition… | 2008 |
| * | K102282 | The Varia Fibula Locked Plating System Line Extension Addition of Straight PlatesSummary page 3…Screws K100271 VariAx Distal Radius Line Extension of XXL Plates K063875 Stryker Foot Plating System K08 1284 VariAx Distal Fibula Plate K 102282 VariAx Locked Plating System Line Extension for Addition of Fibula Straight Plates K073527… | 2010 |
| * | K073527 | Variax Elbow SystemSummary page 3…em K08 1284 VariAx Distal Fibula Plate K 102282 VariAx Locked Plating System Line Extension for Addition of Fibula Straight Plates K073527 VariAx Elbow System K101056 VariAx Elbow System K113760 VariAx Clavicle System K 130009… | 2008 |
| * | K101056 | Variax Elbow SystemSummary page 3…ula Plate K 102282 VariAx Locked Plating System Line Extension for Addition of Fibula Straight Plates K073527 VariAx Elbow System K101056 VariAx Elbow System K113760 VariAx Clavicle System K 130009 VariAx 2 Compression Plating System K… | 2010 |
| * | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Summary page 3…ked Plating System Line Extension for Addition of Fibula Straight Plates K073527 VariAx Elbow System K101056 VariAx Elbow System K113760 VariAx Clavicle System K 130009 VariAx 2 Compression Plating System K000636 Stryker Trauma Platin… | 2012 |
| * | K130009 | Variax 2 Compression Plating SystemSummary page 3…tion of Fibula Straight Plates K073527 VariAx Elbow System K101056 VariAx Elbow System K113760 VariAx Clavicle System K 130009 VariAx 2 Compression Plating System K000636 Stryker Trauma Plating System Non-Clinical Testing Non-clinical… | 2013 |
| * | K000636 | Stryker Trauma Plating SystemSummary page 3…27 VariAx Elbow System K101056 VariAx Elbow System K113760 VariAx Clavicle System K 130009 VariAx 2 Compression Plating System K000636 Stryker Trauma Plating System Non-Clinical Testing Non-clinical laboratory testing was performed for the VariAx 2 Sys… | 2000 |
What descends from it? (21)
See all 214 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 34 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 16 of the 97 ancestors have a recall of any class.
- Of its descendants, K140769 (Stryker Trauma AG, 2014) has gone furthest, with 19 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. 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 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 lntra-ai-ticular and extra-articular fractures;
o Displaced fractures;
o Reconstruction procedures;
* T8 2.7mm 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 lntra-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 & Ankle and Distal Radius;
* TIO 3.5mm and TIO 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;
o 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/K132502 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132502: 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/K132502
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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