510(k) · Cleared
ClearedLoqteq Large Fragment Set Loqteq Cortical Screw 4.5, Small Head, T25, Self Tapping Loqteq Cortical Screw 4.5, T25, Self
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 Sep 6, 2012 as substantially equivalent to K000682 (Synthes (Usa), 2000) after a 269-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Sep 6, 2012
- Review
- 269 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000682 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000682 Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000
- This deviceK113648 Loqteq Large Fragment Set Loqteq Cortical Screw 4.5, Small Head…Aap Implantate AG · 2012
- Descendant · cites it directly · 0 of its ownK141949 Cortical Screw 3.5, T15, Self-Tapping, Titanium, Cortical Screw 4.5…Aap Implantate AG · 2014
Most influential descendants
Showing 1 of 1 · See all- K141949Cortical Screw 3.5, T15, Self-Tapping, Titanium, Cortical Screw 4.5, T25, Self Tapping…Aap Implantate AG · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | — |
| 0 (this device) | K113648 | Loqteq Large Fragment Set Loqteq Cortical Screw 4.5, Small Head, T25, Self… | Aap Implantate AG | 2012 | — |
| +1 | K141949 | Cortical Screw 3.5, T15, Self-Tapping, Titanium, Cortical Screw 4.5, T25, Self… | Aap Implantate AG | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSummary page 1…on, Bone Predicate device: Large Fragment LCP Instrument and Implant Set of Synthes (USA) under the premarket notification K000682 (May -1, 2000). At this time the system was called Synthes Large Frag-… | 2000 |
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 |
|---|---|---|---|
| K141949 | Cortical Screw 3.5, T15, Self-Tapping, Titanium, Cortical Screw 4.5, T25, Self Tapping… | 2014 | 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?
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 ap LOQTEQ* Large Fragment Set includes Narrow and Broad Plates 4.5. The plates
accept 4.5 mm locking screws and 4.5 mm cortical screws.
The aap LOQTEQ7 Large Fragment Set is intended for:
Fixation of various long bones, such as the humerus, femnur and tibia. It is also for use in
fixation of osteopenic bone and fixation of non-unions or malunions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113648: Loqteq Large Fragment Set Loqteq Cortical Screw 4.5, Small Head, T25, Self Tapping Loqteq Cortical Screw 4.5, T25, Self.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113648
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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