510(k) · Cleared
Cleared2.4 MM VA-LCP Volar Rim Distal Radius System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes USA · HRS Plate, Fixation, Bone
Cleared on Apr 21, 2011 as substantially equivalent to K102694 (Synthes (Usa), 2010) and 3 other predicates after a 93-day review. Its family tree reaches back 3 generations to 1996. 5 later devices descend from it.
- Decided
- Apr 21, 2011
- Review
- 93 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K962616 (1996). 9 ancestors in all, the oldest K953644 (1996). 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 2 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 1 generation backK102694 2.4MM VA-LCP Dorsal Distal Radius PlatesSynthes (Usa) · 2010 · Recalled
- This deviceK110125 2.4 MM VA-LCP Volar Rim Distal Radius SystemSynthes USA · 2011
- Descendant · cites it directly · 2 of its ownK171320 ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION…Meril Healthcare Pvt., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK241599 Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK210198 GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius…Gpc Medical Limited · 2022
- Descendant · 2 generations on · 0 of its ownK200701 Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK160553 DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd. · 2018 · cites it directly2descendants
- K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd. · 2025 · 2 generations on0descendants
- K210198GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes…Gpc Medical Limited · 2022 · cites it directly0descendants
- K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc. · 2020 · 2 generations on0descendants
- K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −2 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −1 | K102694 | 2.4MM VA-LCP Dorsal Distal Radius Plates | Synthes (Usa) | 2010 | 3 |
| 0 (this device) | K110125 | 2.4 MM VA-LCP Volar Rim Distal Radius System | Synthes USA | 2011 | — |
| +1 | K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws… | Meril Healthcare Pvt., Ltd. | 2018 | — |
| +2 | K241599 | Signature Osteosynthesis Plate System | Signature Orthopaedic Pty, Ltd. | 2025 | — |
| +1 | K210198 | GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6… | Gpc Medical Limited | 2022 | — |
| +2 | K200701 | Skeletal Dynamics Midshaft Humerus Plating System | Skeletal Dynamics, Inc. | 2020 | — |
| +1 | K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes… | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102694 | 2.4MM VA-LCP Dorsal Distal Radius PlatesSummary page 1…hreaded metallic bone fixation fastener Predicate Device: Synthes 2.4 LCP Volar Column Distal Radius Plating System - (K102694) Synthes Volar Distal Radius Plate - (K(953644) Synthes Varia… | 2010 |
| * | K953644 | Volar Distal Radius PlateSummary page 1…2.4 LCP Volar Column Distal Radius Plating System - (K102694) Synthes Volar Distal Radius Plate - (K(953644) Synthes Variable Angle Locking Compression Plate - (K071184)… | 1996 |
| * | K071184 | Synthes (Usa) Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius SystemSummary page 1…4) Synthes Volar Distal Radius Plate - (K(953644) Synthes Variable Angle Locking Compression Plate - (K071184) Synthes Locking Distal Radius Plating System - (K102694) Syn… | 2007 |
| * | K030310 | Synthes Stainless Steel Modular Hand SystemSummary page 1…Synthes Locking Distal Radius Plating System - (K102694) Synthes Stainless Steel Modular Hand System - (K030310) Synthes Small Titanium Wrist Fusion Plate - (K023987) Device Description: The 2… | 2003 |
| Kept off the family tree | K023987 | FDA’s K023987 is Contaflex 38 (Polymacon) Spherical Soft Contact Lens for Daily Wear (Clear and… Our reading of the summary gave K023987, FDA’s number for Contaflex 38 (Polymacon) Spherical Soft Contact Lens for… (Contamac, Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Synthes Small Titanium Wrist Fusion Plate”. Kept off the family tree. Summary page 1…Synthes Stainless Steel Modular Hand System - (K030310) Synthes Small Titanium Wrist Fusion Plate - (K023987) Device Description: The 2.4mm Variable Angle LCP Distal Radius Plates are used with a… | 2003 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS… | 2018 | 2 |
| K210198 | GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes… | 2022 | 0 |
| K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist… | 2017 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K171320 (Meril Healthcare Pvt., Ltd., 2018) has gone furthest, with 2 descendants of its own.
- 12 other devices also cite its predicate K102694.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 2,4mm Variable Angle LCP Volar Rim Distal Radius Plates are intended for
Fixation of complex intra- and extra-articular fractures and osteotomies of the distal
radius and other small bones in adults, skeletally mature adolescents, and the
following adolescent distal radius fractures: intra-articular fractures exiting the
epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and
any injuries which cause growth arrest to the distal radius.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110125: 2.4 MM VA-LCP Volar Rim Distal Radius System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110125
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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