510(k) · Cleared
ClearedLoqteq High Tibia Osteotomy Plate 4.5
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 Nov 18, 2013 as substantially equivalent to K023941 (Synthes (Usa), 2003) and 1 other predicate after a 154-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Nov 18, 2013
- Review
- 154 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K023941 (2003). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK023941 Synthes Tomofix Osteotomy SystemSynthes (Usa) · 2003 · Recalled
- This deviceK131782 Loqteq High Tibia Osteotomy Plate 4.5Aap Implantate AG · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023941 | Synthes Tomofix Osteotomy System | Synthes (Usa) | 2003 | 1 |
| 0 (this device) | K131782 | Loqteq High Tibia Osteotomy Plate 4.5 | Aap Implantate AG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K023941 | Synthes Tomofix Osteotomy SystemSummary page 1…Code: HRS Predicate device: Synthes TomoFiXTM Osteotomy System under the pre- market notification K(023941 (Jan 23, 2003) and Synthes (USA) TomoFiXTM Medial Distal Femur Plates under the… | 2003 |
| * | K081353 | Synthes (Usa) Tomofix Medial Distal Femur PlatesSummary page 1…(Jan 23, 2003) and Synthes (USA) TomoFiXTM Medial Distal Femur Plates under the premarket notification K081353 (Jul 23. 2006). Device Description: The aap LOQTEO®R Osteotomy System consists of bone… | 2008 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 8 other devices also cite its predicate K023941.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 indication for use of the aap LOQTEQ® Osteotomy System are:
LOQTEQ® High Tibial Osteotomy Plate 4.5:
* Open-wedge osteotomies at the proximal medial tibia
* Treatment of bone and joint deformities
* Treatment of malpositions caused by injuries or disorders such as osteoarthritis
LOQTEQ® Distal Femur Osteotomy Plate 4.5:
* Closed-wedge osteotomies of the medial distal femur
* Treatment of bone and joint deformities
* Treatment of malpositions caused by injuries or disorders such as osteoarthritis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131782: Loqteq High Tibia Osteotomy Plate 4.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131782
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