510(k) · Cleared
ClearedLOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5
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 Nov 22, 2016 as substantially equivalent to K113652 (Aap Implantate AG, 2012) and 2 other predicates after a 151-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Nov 22, 2016
- Review
- 151 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K000684 (2000). 14 ancestors in all, the oldest K882831 (1988). No later device cites it as a predicate yet.
- Root · 4 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 3 generations backK060710 Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835…Zimmer, Inc. · 2006 · Recalled
- 2 generations backK082527 Zimmer Universal Locking System: 3.5 MM Locking Plates and ScrewsZimmer, Inc. · 2008 · Recalled
- 1 generation backK113652 Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15…Aap Implantate AG · 2012
- This deviceK161747 LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia…Aap Implantate AG · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −3 | K060710 | Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws | Zimmer, Inc. | 2006 | 5 |
| −2 | K082527 | Zimmer Universal Locking System: 3.5 MM Locking Plates and Screws | Zimmer, Inc. | 2008 | 5 |
| −1 | K113652 | Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15, Self… | Aap Implantate AG | 2012 | — |
| 0 (this device) | K161747 | LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate… | Aap Implantate AG | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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? (3)
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 |
|---|---|---|---|
| * | K113652 | Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15, Self Tapping Loqteq…Summary page 4…Orthopedics/87/HWC (3) Predicate devices aap LOQTEQ 1/3 Tubular Plate 3.5 under the premarket notification K113652 Synthes (USA): LCP Distal Tibia Plates under the premarket notification… | 2012 |
| * | K013248 | Synthes LCP Distal Tibia PlatesSummary page 4…K113652 Synthes (USA): LCP Distal Tibia Plates under the premarket notification K013248 Synthes (USA): 2.7 mm/3.5 mm LCP Anterolateral Distal Tibia Plates… | 2001 |
| * | K092812 | Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSummary page 4…13248 Synthes (USA): 2.7 mm/3.5 mm LCP Anterolateral Distal Tibia Plates under the premarket notification K092812 (4) Device Description: The aap LOQTEQ® VA Distal Tibia Plate System consists of bone plates… | 2010 |
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 16 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 5 of the 14 ancestors have a recall of any class.
- 4 other devices also cite its predicate K113652.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Distal Medial Tibia Plate 3.5
* Fixation of complex intra- and extra-articular fractures of the distal tibia; osteotomies of the distal tibia
LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5
* fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone
LOQTEQ® VA Distal Fibula Plate 2.7/3.5
* fractures, osteotomies, and non-unions of the distal fibula, especially in osteopenic bone
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161747 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161747: LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161747
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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