510(k) · Cleared
Recalled · Class II · 2016Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate Narrow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on Oct 9, 2013 as substantially equivalent to K112345 (Medos International SARL, 2011) after a 41-day review. Its family tree reaches back 1 generation to 2011. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 9, 2013
- Review
- 41 days
- Class
- Class II
- Product code
- LXT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K112345 (2011). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK112345 Distal Volar Radius Plating SystemsMedos International SARL · 2011 · Recalled
- This deviceK132704 Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim…Biomet · 2013
- Descendant · cites it directly · 1 of its ownK191118 Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK261145 Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K112345 | Distal Volar Radius Plating Systems | Medos International SARL | 2011 | 4 |
| 0 (this device) | K132704 | Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate Narrow | Biomet | 2013 | — |
| +1 | K191118 | Avanti Distal Radius and Forearm System | Avanti Orthopaedics, Inc. | 2019 | — |
| +2 | K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 LXT? 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 LXT device
- #1 K230067 Para-Fix External Fixation Systemscore 6.3 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K112345 | Distal Volar Radius Plating SystemsSummary page 1…ar Rim Plating System is substantially equivalent to currently marketed Distal Volar Radius Plating System (K112345). Device Description: The Distal Radius Volar Rim Plating System consists of a series of… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191118 | Avanti Distal Radius and Forearm System | 2019 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 29, 2016 | Class II | Z-1082-2016 | Package design/selection | Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-sterilize the product. If oxidative material would flake off a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LXT devicesLXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LXT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LXT
Too few LXT 510(k)s in any year since 2007 to give a median.
Recalls per year · LXT
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXT
7in 2025
MAUDE reports naming product code LXT, 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 | 1 | — | 1 | 26 |
| 2008 | 1 | — | 0 | 58 |
| 2009 | 1 | — | 7 | 41 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 1 | — | 0 | 85 |
| 2012 | 0 | — | 0 | 42 |
| 2013 | 2 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 35 |
| 2016 | 0 | — | 0 | 38 |
| 2017 | 0 | — | 0 | 66 |
| 2018 | 0 | — | 2 | 73 |
| 2019 | 0 | — | 0 | 40 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 21 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 27 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The system Is intended for fixation of fractures, malunions and osteotomies involving the dlistal radius.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132704: Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate Narrow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132704
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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