Aap Implantate AG: FDA filings under this applicant name
FDA lists 37 510(k) clearances under the applicant name “Aap Implantate AG” (first 1999, latest 2026), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 109 days. Since 2017 the median was 150 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 6 | 266 |
| 2013 | 6 | 96 |
| 2014 | 4 | 56 |
| 2015 | 1 | 16 |
| 2016 | 4 | 144 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 282 |
| 2020 | 0 | — |
| 2021 | 2 | 102 |
| 2022 | 0 | — |
| 2023 | 1 | 58 |
| 2024 | 1 | 257 |
| 2025 | 0 | — |
| 2026 | 1 | 85 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Aap Implantate AG took a median 150 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 25 | 25 |
| HWC | Screw, Fixation, Bone | 8 | 8 |
| JDS | Nail, Fixation, Bone | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
Review panels
- Orthopedic (37)
Most recent Aap Implantate AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | HRS | 2026-03-24 | 85 |
| K233008 | Cannulated Headless Bone Screws | HWC | 2024-06-05 | 257 |
| K230141 | LOQTEQ® VA Elbow Plates 2.7/3.5 System | HRS | 2023-03-17 | 58 |
| K211582 | LOQTEQ Proximal Humerus Plate 3.5 System | HRS | 2021-10-18 | 150 |
| K210043 | LOQTEQ Distal Lateral Femur Plate 4.5 System | HRS | 2021-03-03 | 55 |
| K182818 | LOQTEQ VA Calcaneus Plate 3.5 | HRS | 2019-08-01 | 302 |
| K182785 | LOQTEQ VA Foot Plates 2.5 | HRS | 2019-06-19 | 261 |
| K161696 | aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 | HRS | 2016-11-23 | 156 |
| 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 | HRS | 2016-11-22 | 151 |
| K161703 | LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer | HRS | 2016-11-04 | 137 |
27 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2019-11-28.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Aap Implantate AG is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05260463: LOQTEQ® Antibacterial Pre-Market Study (Completed, started 2021-12-09)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aap Implantate AG?
FDA lists 37 510(k) clearances under the applicant name “Aap Implantate AG” (first 1999, latest 2026), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aap Implantate AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aap Implantate AG is 109 days. Since 2017: 150 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Aap Implantate AG?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 25); HWC (Screw, Fixation, Bone, 8); JDS (Nail, Fixation, Bone, 1).
Next steps
- See all 37 Aap Implantate AG clearances with predicates and recalls
- Run predicate analysis for product code HRS, Aap Implantate AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.