510(k) · Cleared
ClearedVari AX Distal Radius Line Extensions of XXL Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HRS Plate, Fixation, Bone
Cleared on May 14, 2010 as substantially equivalent to K040022 (Stryker Leibinger, 2004) and 2 other predicates after a 105-day review. Its family tree reaches back 3 generations to 1989. 80 later devices descend from it.
- Decided
- May 14, 2010
- Review
- 105 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K885250 (1989). 12 ancestors in all. 80 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK885250 Alta Tibial/Upper Extremity Metaphyseal Plate SysHowmedica Corp. · 1989
- 2 generations backK981283 Rogachefsky Distal Radius PlatesHowmedica, Inc. · 1998
- 1 generation backK040022 Stryker Leibinger Universal Distal Radius SystemStryker Leibinger · 2004
- This deviceK100271 Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp. · 2010
- Descendant · cites it directly · 56 of its ownK112455 Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2011
- Descendant · 2 generations on · 40 of its ownK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- Descendant · cites it directly · 21 of its ownK132502 Variax 2 SystemStryker Trauma AG · 2013
- Descendant · cites it directly · 20 of its ownK133974 Variax Distal Radius Plating SystemStryker Leibinger GmbH · 2014
- Descendant · cites it directly · 20 of its ownK131474 Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K112455Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2011 · cites it directly56descendants
- K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012 · 2 generations on40descendants
- K132502Variax 2 SystemStryker Trauma AG · 2013 · cites it directly21descendants
- K133974Variax Distal Radius Plating SystemStryker Leibinger GmbH · 2014 · cites it directly20descendants
- K131474Arthrex Distal Radius Plate SystemArthrex, Inc. · 2013 · cites it directly20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K885250 | Alta Tibial/Upper Extremity Metaphyseal Plate Sys | Howmedica Corp. | 1989 | — |
| −2 | K981283 | Rogachefsky Distal Radius Plates | Howmedica, Inc. | 1998 | — |
| −1 | K040022 | Stryker Leibinger Universal Distal Radius System | Stryker Leibinger | 2004 | — |
| 0 (this device) | K100271 | Vari AX Distal Radius Line Extensions of XXL Plates | Howmedica Osteonics Corp. | 2010 | — |
| +1 | K112455 | Aiming Blocks for Variax Distal Radius Plates | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 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 | — |
| +1 | K133974 | Variax Distal Radius Plating System | Stryker Leibinger GmbH | 2014 | — |
| +1 | K131474 | Arthrex Distal Radius Plate System | Arthrex, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 7 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 4 | 0 |
| 2024 | 11 | 0 |
| 2025 | 7 | 0 |
| 2026 | 9 | 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? (3)
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 |
|---|---|---|---|
| * | K040022 | Stryker Leibinger Universal Distal Radius SystemSummary page 2…to intended use, design materials and operational principles. The following devices are examples of predicate systems: Stryker Leibinger Universal Distal Radius System (K040022) which is marketed under the name of VariAx Distal Radius System, Synthes Diaphyseal-Metaphyseal Volar Distal Radius Plate (K0709… | 2004 |
| * | K070946 | Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius PlatesSummary page 2…inger Universal Distal Radius System (K040022) which is marketed under the name of VariAx Distal Radius System, Synthes Diaphyseal-Metaphyseal Volar Distal Radius Plate (K070946), and Zimmer Periarticular Locking Plate System (K040593). Based upon the mechanical testing, the VariAx Distal Radius Line Exten… | 2007 |
| * | K040593 | Periarticular Locking Plates and Screws, 2358, 2359 SeriesSummary page 2…arketed under the name of VariAx Distal Radius System, Synthes Diaphyseal-Metaphyseal Volar Distal Radius Plate (K070946), and Zimmer Periarticular Locking Plate System (K040593). Based upon the mechanical testing, the VariAx Distal Radius Line Extension of XXL Plates is substantially equivalent for its in… | 2004 |
What descends from it? (80)
See all 804 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 21 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K112455 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2011) has gone furthest, with 56 descendants of its own.
- 11 other devices also cite its predicate K040022.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 indications for use of the Distal Radius System:
The Stryker® XXL Volar Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100271 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100271: Vari AX Distal Radius Line Extensions of XXL Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100271
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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