510(k) · Cleared
ClearedSynthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on Feb 20, 2004 after a 74-day review. The FDA summary names its predicate without a number. 142 later devices descend from it.
- Decided
- Feb 20, 2004
- Review
- 74 days
- Class
- Class II
- Product code
- LXT
- Recalls
- None
- Predicates
- 0
142 later devices descend from it, 7 citing it directly.
- This deviceK033805 Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal PlatesSynthes (Usa) · 2004
- Descendant · cites it directly · 71 of its ownK103332 Aptus Ulna PlatesMedartis AG · 2011
- Descendant · 2 generations on · 59 of its ownK142906 APTUS Wrist 2.5 SystemMedartis AG · 2015
- Descendant · cites it directly · 44 of its ownK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- Descendant · cites it directly · 31 of its ownK042598 Periarticular Locking Plates and Screws, 2357 and 2359 SeriesZimmer, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 27 of its ownK050121 Zimmer Periarticular Locking Plate System, Model 2357 & 2359Zimmer, Inc. · 2005
Showing 5 of 142 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 142 · See all- K103332Aptus Ulna PlatesMedartis AG · 2011 · cites it directly71descendants
- K142906APTUS Wrist 2.5 SystemMedartis AG · 2015 · 2 generations on59descendants
- K120854Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012 · cites it directly44descendants
- K042598Periarticular Locking Plates and Screws, 2357 and 2359 SeriesZimmer, Inc. · 2004 · cites it directly31descendants
- K050121Zimmer Periarticular Locking Plate System, Model 2357 & 2359Zimmer, Inc. · 2005 · 2 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033805 | Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal Plates | Synthes (Usa) | 2004 | — |
| +1 | K103332 | Aptus Ulna Plates | Medartis AG | 2011 | — |
| +2 | K142906 | APTUS Wrist 2.5 System | Medartis AG | 2015 | — |
| +1 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| +1 | K042598 | Periarticular Locking Plates and Screws, 2357 and 2359 Series | Zimmer, Inc. | 2004 | 1 |
| +2 | K050121 | Zimmer Periarticular Locking Plate System, Model 2357 & 2359 | Zimmer, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 9 | 0 |
| 2018 | 9 | 0 |
| 2019 | 8 | 0 |
| 2020 | 11 | 0 |
| 2021 | 9 | 0 |
| 2022 | 5 | 0 |
| 2023 | 7 | 0 |
| 2024 | 16 | 0 |
| 2025 | 17 | 0 |
| 2026 | 20 | 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? (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 |
|---|---|---|---|
| * | — | Synthes (USA) Small Fragment DCL System Named without a submission number | |
| * | — | Synthes (USA) Large Fragment DCL System Named without a submission number |
What descends from it? (142)
See all 1427 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103332 | Aptus Ulna Plates | 2011 | 71 |
| K120854 | Synthes VA LCP Ankle Trauma System | 2012 | 44 |
| K042598 | Periarticular Locking Plates and Screws, 2357 and 2359 Series | 2004 | 31 |
| K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plate | 2012 | 6 |
| K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment… | 2024 | 4 |
| K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | 2018 | 4 |
| K201229 | Intai Anatomic Locking Plate and Screw System | 2022 | 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?
- Of its descendants, K103332 (Medartis AG, 2011) has gone furthest, with 71 descendants of its own.
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.
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 Synthes (USA) 3.5 /4.5mm LCP® Metaphyseal Plate is intended for the fixation of various long bones, excluding the femur. It is also for use in fixation of osteopenic bone and fixation of nonunions or malunions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033805: Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033805
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