510(k) · Cleared
ClearedLoqteq Distal Lateral Femur Plate 4.5 (Left and Right Version) Loqreq Cortical Screw 4.5 T25, Self-Tapping
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 Nov 19, 2012 as substantially equivalent to K062564 (Synthes (Usa), 2006) after a 182-day review. Its family tree reaches back 1 generation to 2006. 2 later devices descend from it.
- Decided
- Nov 19, 2012
- Review
- 182 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062564 (2006). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK062564 Synthes LCP Distal Femur PlatesSynthes (Usa) · 2006
- This deviceK121494 Loqteq Distal Lateral Femur Plate 4.5 (Left and Right Version)…Aap Implantate AG · 2012
- Descendant · cites it directly · 1 of its ownK210043 LOQTEQ Distal Lateral Femur Plate 4.5 SystemAap Implantate AG · 2021
- Descendant · 2 generations on · 0 of its ownK232115 TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2024
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 | K062564 | Synthes LCP Distal Femur Plates | Synthes (Usa) | 2006 | — |
| 0 (this device) | K121494 | Loqteq Distal Lateral Femur Plate 4.5 (Left and Right Version) Loqreq Cortical… | Aap Implantate AG | 2012 | — |
| +1 | K210043 | LOQTEQ Distal Lateral Femur Plate 4.5 System | Aap Implantate AG | 2021 | — |
| +2 | K232115 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K062564 | Synthes LCP Distal Femur PlatesSummary page 1…crew, Fixation, Bone Predicate device: LCPO Distal Femur Plates of Synthes (USA) with premarket noti- fication no. K062564 (OCT 19, 2006). Device Description: Bone plates and screws are used for fixation of bone fragments,… | 2006 |
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 |
|---|---|---|---|
| K210043 | LOQTEQ Distal Lateral Femur Plate 4.5 System | 2021 | 1 |
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?
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 aap LOQTEQ6 Distal Lateral Femur Plate 4.5 System include plates for the left and right human femur. The plates accept 4.5 MM locking screws, 4.5 mm cortical screws and 4.5 mm periprosthetic screws. They are intended 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/K121494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121494: Loqteq Distal Lateral Femur Plate 4.5 (Left and Right Version) Loqreq Cortical Screw 4.5 T25, Self-Tapping.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121494
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