510(k) · Cleared
ClearedVariAx Distal Radius Plating System, VariAx 2 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 Feb 21, 2017 as substantially equivalent to K141430 (Stryker Leibinger GmbH & Co KG, 2014) and 1 other predicate after a 133-day review. Its family tree reaches back 12 generations to 1979. 4 later devices descend from it.
- Decided
- Feb 21, 2017
- Review
- 133 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K792022 (1979). 107 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations between
- 3 generations backK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- 2 generations backK132502 Variax 2 SystemStryker Trauma AG · 2013
- 1 generation backK140769 Variax 2 SystemStryker Trauma AG · 2014
- This deviceK162841 VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH · 2017
- Descendant · cites it directly · 3 of its ownK191641 AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable…Industrias Medicas Sampedro S.A.S · 2019
- Descendant · 2 generations on · 1 of its ownK242343 BPS Wrist Fracture SystemOrthonovis, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK250498 BPS Wrist Fracture SystemOrthonovis, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK220199 AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc. · 2022
Show all 12 generations
- Root · 12 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 11 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 10 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 9 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 8 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 7 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 6 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 5 generations backK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
- 4 generations backK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- 3 generations backK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- 2 generations backK132502 Variax 2 SystemStryker Trauma AG · 2013
- 1 generation backK140769 Variax 2 SystemStryker Trauma AG · 2014
- This deviceK162841 VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH · 2017
Most influential descendants
Showing 4 of 4 · See all- K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S · 2019 · cites it directly3descendants
- K242343BPS Wrist Fracture SystemOrthonovis, Inc. · 2024 · 2 generations on1descendant
- K250498BPS Wrist Fracture SystemOrthonovis, Inc. · 2025 · 2 generations on0descendants
- K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −11 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −10 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −9 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −8 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −7 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −6 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −5 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
| −4 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| −3 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| −2 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
| −1 | K140769 | Variax 2 System | Stryker Trauma AG | 2014 | — |
| 0 (this device) | K162841 | VariAx Distal Radius Plating System, VariAx 2 System | Stryker GmbH | 2017 | — |
| +1 | K191641 | AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle… | Industrias Medicas Sampedro S.A.S | 2019 | — |
| +2 | K242343 | BPS Wrist Fracture System | Orthonovis, Inc. | 2024 | — |
| +2 | K250498 | BPS Wrist Fracture System | Orthonovis, Inc. | 2025 | — |
| +2 | K220199 | AFFINITY Proximal Tibia System | Techfit Digital Surgery, Inc. | 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 | 4 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K141430 | Variax Distal Radius Plating SystemSummary page 6…Phone: +1 201 831 6365 Date Prepared: December 13, 2016 Primary Predicate: VariAx Distal Radius Plating System, K141430 Reference Predicate: VariAx 2 System (screws), K140769 Description This Traditional 510(k) submission is intended to provi… | 2014 |
| * | K140769 | Variax 2 SystemSummary page 6…pared: December 13, 2016 Primary Predicate: VariAx Distal Radius Plating System, K141430 Reference Predicate: VariAx 2 System (screws), K140769 Description This Traditional 510(k) submission is intended to provide information on a new packaging configuration of the VariAx… | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191641 | AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius… | 2019 | 3 |
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 38 years and passes through 10 companies; a new generation was cleared every 1.8 years on median.
- 19 of the 107 ancestors have a recall of any class.
- Of its descendants, K191641 (Industrias Medicas Sampedro S.A.S, 2019) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K141430.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Distal Radius Plating System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures. Indications include: * compression fractures * intra-articular and extra-articular fractures * displaced fractures Following additional indications apply only for the XXL Volar Distal Radius Plates: Osteotomies, non-unions, and mal-unions. The Stryker VariAx 2 System…
Read the full statement (280 words)
The VariAx Distal Radius Plating System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures.
Indications include:
* compression fractures
* intra-articular and extra-articular fractures
* displaced fractures
Following additional indications apply only for the XXL Volar Distal Radius Plates: Osteotomies, non-unions, and mal-unions.
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 2.7mm 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 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 & Ankle and Distal Radius;
* TI0 3.5mm and T10 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162841 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162841: VariAx Distal Radius Plating System, VariAx 2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162841
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