510(k) · Cleared
ClearedVariax Distal Radius Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger GmbH & Co KG · HRS Plate, Fixation, Bone
Cleared on Jul 18, 2014 as substantially equivalent to K060041 (TriMed, Inc., 2006) after a 49-day review. Its family tree reaches back 8 generations to 1996. 12 later devices descend from it.
- Decided
- Jul 18, 2014
- Review
- 49 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K962616 (1996). 29 ancestors in all, the oldest K890939 (1989). 12 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 2 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 1 generation backK060041 Trimed Bone PlatesTriMed, Inc. · 2006 · Recalled
- This deviceK141430 Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG · 2014
- Descendant · cites it directly · 4 of its ownK162841 VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH · 2017
- Descendant · cites it directly · 4 of its ownK161292 Distal Radius Plating SystemMiami Device Solutions, LLC · 2016
- Descendant · 2 generations on · 3 of its ownK191641 AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable…Industrias Medicas Sampedro S.A.S · 2019
- Descendant · 2 generations on · 2 of its ownK162635 Distal Radius Plating SystemMiami Device Solutions, LLC · 2016
- Descendant · 3 generations on · 1 of its ownK242343 BPS Wrist Fracture SystemOrthonovis, Inc. · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH · 2017 · cites it directly4descendants
- K161292Distal Radius Plating SystemMiami Device Solutions, LLC · 2016 · cites it directly4descendants
- K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S · 2019 · 2 generations on3descendants
- K162635Distal Radius Plating SystemMiami Device Solutions, LLC · 2016 · 2 generations on2descendants
- K242343BPS Wrist Fracture SystemOrthonovis, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −7 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −6 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −5 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −2 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −1 | K060041 | Trimed Bone Plates | TriMed, Inc. | 2006 | 3 |
| 0 (this device) | K141430 | Variax Distal Radius Plating System | Stryker Leibinger GmbH & Co KG | 2014 | — |
| +1 | K162841 | VariAx Distal Radius Plating System, VariAx 2 System | Stryker GmbH | 2017 | — |
| +1 | K161292 | Distal Radius Plating System | Miami Device Solutions, LLC | 2016 | — |
| +2 | K191641 | AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle… | Industrias Medicas Sampedro S.A.S | 2019 | — |
| +2 | K162635 | Distal Radius Plating System | Miami Device Solutions, LLC | 2016 | — |
| +3 | K242343 | BPS Wrist Fracture System | Orthonovis, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K060041 | Trimed Bone PlatesSummary page 2…s: Osteotomies, non-unions, and malunions. Summary of Technologies Device comparison showed that subject device is substantially equivalent to the TriMed Wrist Plates (K060041) in regards to intended use, and operational principles for use for internal fixation for fractures of the bones in the distal ra… | 2006 |
What descends from it? (12)
See all 123 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 18 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 29 ancestors have a recall of any class.
- Of its descendants, K162841 (Stryker GmbH, 2017) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K060041.
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 VariAx Distal Radius Locking 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 malunions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141430: Variax Distal Radius Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141430
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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