510(k) · Cleared
ClearedLOQTEQ Distal Lateral Femur Plate 4.5 System
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 3, 2021 as substantially equivalent to K121494 (Aap Implantate AG, 2012) and 1 other predicate after a 55-day review. Its family tree reaches back 2 generations to 2006. 1 later device descends from it.
- Decided
- Mar 3, 2021
- Review
- 55 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K062564 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK062564 Synthes LCP Distal Femur PlatesSynthes (Usa) · 2006
- 1 generation backK121494 Loqteq Distal Lateral Femur Plate 4.5 (Left and Right Version)…Aap Implantate AG · 2012
- This deviceK210043 LOQTEQ Distal Lateral Femur Plate 4.5 SystemAap Implantate AG · 2021
- Descendant · cites it directly · 0 of its ownK232115 TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K062564 | Synthes LCP Distal Femur Plates | Synthes (Usa) | 2006 | — |
| −1 | K121494 | Loqteq Distal Lateral Femur Plate 4.5 (Left and Right Version) Loqreq Cortical… | Aap Implantate AG | 2012 | — |
| 0 (this device) | K210043 | LOQTEQ Distal Lateral Femur Plate 4.5 System | Aap Implantate AG | 2021 | — |
| +1 | K232115 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K121494 | Loqteq Distal Lateral Femur Plate 4.5 (Left and Right Version) Loqreq Cortical Screw 4.5…Summary page 4…6C) Stereotaxic, Bone Growth Stimulators and Fracture Fixation Devices Team PREDICATE DEVICE INFORMATION Primary Predicate K121494, aap LOQTEQ Distal Lateral Femur Plate 4.5 System Additional Predicate K062564, Synthes LCP Distal Femur Plates Reference Devic… | 2012 |
| * | K062564 | Synthes LCP Distal Femur PlatesSummary page 4…ion Devices Team PREDICATE DEVICE INFORMATION Primary Predicate K121494, aap LOQTEQ Distal Lateral Femur Plate 4.5 System Additional Predicate K062564, Synthes LCP Distal Femur Plates Reference Device K153034, aap LOQTEQ® VA Radius Set 2.5 510(k) Summary… | 2006 |
| † | K153034 | aap LOQTEQ VA Radius Set 2.5 | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232115 | TDM Large Bone Plate and Screw System | 2024 | 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 2 companies; a new generation was cleared every 8.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K232115 (Tdm Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures; fractures in normal or osteopenic bone; non-unions and malunions; and osteotomies of the femur
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210043: LOQTEQ Distal Lateral Femur Plate 4.5 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210043
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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