AAP Implantate AG
Berlin, DE
AAP IMPLANTATE AG appears in FDA device records in Berlin, DE. FDA records list 37 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 37 510(k) clearances for AAP Implantate AG between 1999 and 2026. The busiest year on record is 2012, with 6. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2011 | 1 |
| 2012 | 6 |
| 2013 | 6 |
| 2014 | 4 |
| 2015 | 1 |
| 2016 | 4 |
| 2019 | 2 |
| 2021 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | HRS | Substantially Equivalent | |
| K233008 | Cannulated Headless Bone Screws | HWC | Substantially Equivalent | |
| K230141 | LOQTEQ® VA Elbow Plates 2.7/3.5 System | HRS | Substantially Equivalent | |
| K211582 | LOQTEQ Proximal Humerus Plate 3.5 System | HRS | Substantially Equivalent | |
| K210043 | LOQTEQ Distal Lateral Femur Plate 4.5 System | HRS | Substantially Equivalent | |
| K182818 | LOQTEQ VA Calcaneus Plate 3.5 | HRS | Substantially Equivalent | |
| K182785 | LOQTEQ VA Foot Plates 2.5 | HRS | Substantially Equivalent | |
| K161696 | aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 | HRS | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K161703 | LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer | HRS | Substantially Equivalent | |
| K153034 | aap LOQTEQ VA Radius Set 2.5 | HRS | Substantially Equivalent | |
| K150974 | aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium | HWC | Substantially Equivalent | |
| K141949 | CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM | HWC | Substantially Equivalent | |
| K141823 | AAP LOQTEC CLAVICLE PLATES 2.7/3.5 | HRS | Substantially Equivalent | |
| K140607 | AAP LOQTEC(R) OLECRANON PLATE | HRS | Substantially Equivalent | |
| K133675 | AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5 | HRS | Substantially Equivalent | |
| K132787 | LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE | HRS | Substantially Equivalent | |
| K131782 | LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5 | HRS | Substantially Equivalent | |
| K131459 | AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE | JDW | Substantially Equivalent | |
| K132554 | AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 | HRS | Substantially Equivalent | |
| K130590 | AAP CANNULATED SCREW 2.0 | HWC | Substantially Equivalent | |
| K123875 | AAP RADIUS SET 2.5 | HRS | Substantially Equivalent | |
| K121495 | LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG | HRS | Substantially Equivalent | |
| K121494 | LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING | HRS | Substantially Equivalent | |
| K113601 | AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM | HRS | Substantially Equivalent | |
| K113602 | AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM | HRS | Substantially Equivalent | |
| K113648 | LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF | HRS | Substantially Equivalent | |
| K113652 | LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T | HRS | Substantially Equivalent | |
| K111316 | AAP CANNULATED SCREWS | HWC | Substantially Equivalent | |
| K080101 | AAP CANNULATED SCREW AND DARCO HEADED SCREW | HWC | Substantially Equivalent | |
| K072411 | AAP BONE PLATES AND SCREW IMPLANTS | HRS | Substantially Equivalent | |
| K071852 | AAP APS SYSTEM | KTT | Substantially Equivalent | |
| K033260 | AEQUOS | JWH | Substantially Equivalent | |
| K030909 | AAP ACROPLATE | HRS | Substantially Equivalent | |
| K021233 | AAP CANNULATED SCREWS | HWC | Substantially Equivalent | |
| K021782 | BNF | JDS | Substantially Equivalent | |
| K990776 | AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM | HWC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8043862 | 3001406084 | AAP IMPLANTATE AG | LORENZWEG 5, BERLIN 12099 DE | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- HTWBit, Drill
- FZOChisel, Surgical, Manual
- HWWCountersink
- GFCDriver, Surgical, Pin
- HTDForceps
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- HWAImpactor
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- JDSNail, Fixation, Bone
- LXHOrthopedic Manual Surgical Instrument
- HTYPin, Fixation, Smooth
- JDWPin, Fixation, Threaded
- HRSPlate, Fixation, Bone
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HTOReamer
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- HWXTap, Bone
- FSMTray, Surgical, Instrument
- HTNWasher, Bolt Nut
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1675-2020 | aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00 | The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo. | Class II | Terminated | |
| Z-0732-2020 | INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425 | Products were distributed with the incorrect instructions for use. | Class III | Terminated | |
| Z-0731-2020 | INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453 | Products were distributed with the incorrect instructions for use. | Class III | Terminated | |
| Z-1019-2019 | aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use. | There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain