510(k) · Cleared
ClearedLOQTEQ® VA Proximal Humerus Plate 3.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aap Implantate AG · HRS Plate, Fixation, Bone
Cleared on Mar 24, 2026 as substantially equivalent to K211582 (Aap Implantate AG, 2021) after an 85-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Mar 24, 2026
- Review
- 85 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011815 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK011815 Synthes LCP Proximal Humerus PlatesSynthes (Usa) · 2001
- 2 generations backK121495 Loqteq Proximal Humerus Plate 3.5, Short Loqteq Proximal Humerus…Aap Implantate AG · 2012
- 1 generation backK211582 LOQTEQ Proximal Humerus Plate 3.5 SystemAap Implantate AG · 2021
- This deviceK254253 LOQTEQ® VA Proximal Humerus Plate 3.5Aap Implantate AG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011815 | Synthes LCP Proximal Humerus Plates | Synthes (Usa) | 2001 | — |
| −2 | K121495 | Loqteq Proximal Humerus Plate 3.5, Short Loqteq Proximal Humerus Plate 3.5, Long | Aap Implantate AG | 2012 | — |
| −1 | K211582 | LOQTEQ Proximal Humerus Plate 3.5 System | Aap Implantate AG | 2021 | — |
| 0 (this device) | K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | Aap Implantate AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K211582 | LOQTEQ Proximal Humerus Plate 3.5 SystemSummary page 5…n of Restorative, Repair and Trauma Devices (DHT6C) Restorative, Repair and Trauma Devices PREDICATE DEVICE INFORMATION Primary Predicate Device K211582, LOQTEQ® Proximal Humerus Plate 3.5 System, aap Implantate AG Reference Devices K121495, LOQTEQ® Proximal Humerus Plate 3.5 Syst… | 2021 |
| † | K121495 | Loqteq Proximal Humerus Plate 3.5, Short Loqteq Proximal Humerus Plate 3.5, Long | 2012 |
| † | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, Long | 2004 |
| † | K230141 | LOQTEQ® VA Elbow Plates 2.7/3.5 System | 2023 |
| † | K113652 | Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15, Self Tapping Loqteq… | 2012 |
| † | K233008 | Cannulated Headless Bone Screws | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 2 companies; a new generation was cleared every 8.9 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
LOQTEQ® VA Proximal Humerus Plate 3.5 is indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254253: LOQTEQ® VA Proximal Humerus Plate 3.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254253
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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