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Data / Medical devices / Germany / Aap Implantate AG

Aap Implantate AG: FDA-registered device maker in Berlin, Germany, 35 510(k) clearances

Aap Implantate AG is registered with the FDA (registration 8043862) in Berlin, Germany. It lists 24 device types. The FDA files 35 510(k) clearances under its listings, the newest dated March 24, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Aap Implantate AG
FDA registration number
8043862
FEI number
3001406084
Address
Lorenzweg 5, Berlin, Germany, 12099
Owner or operator
AAP IMPLANTATE AG (9004207)
Roles
Manufacturer
First device listed
October 3, 1994
Registered through
2026
Brand names listed
AAP Bone Plates and Screw Implants, AAP CHISEL, AAP COMPRESSION DEVICE, AAP Cannulated Screws, AAP DEPTH GAUGE, AAP FORCEPS, AAP HAMMER, AAP IMPACTOR and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT2Manufactureraccessdata.fda.gov
Bit, DrillHTW1Manufactureraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Manufactureraccessdata.fda.gov
CountersinkHWW1Manufactureraccessdata.fda.gov
Driver, Surgical, PinGFC1Manufactureraccessdata.fda.gov
ForcepsHTD1Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Hammer, SurgicalFZY1Manufactureraccessdata.fda.gov
ImpactorHWA1Manufactureraccessdata.fda.gov
Instrument, Bending Or ContouringHXP1Manufactureraccessdata.fda.gov
Instrument, CompressionHWN1Manufactureraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Manufactureraccessdata.fda.gov
Pin, Fixation, ThreadedJDW2Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Manufactureraccessdata.fda.gov
ReamerHTO1Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Tap, BoneHWX1Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Manufactureraccessdata.fda.gov
WrenchHXC1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 24, 2026K254253LOQTEQ® VA Proximal Humerus Plate 3.5HRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
June 5, 2024K233008Cannulated Headless Bone ScrewsHWCSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
March 17, 2023K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemHRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
October 18, 2021K211582LOQTEQ Proximal Humerus Plate 3.5 SystemHRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
March 3, 2021K210043LOQTEQ Distal Lateral Femur Plate 4.5 SystemHRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
August 1, 2019K182818LOQTEQ VA Calcaneus Plate 3.5HRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
June 19, 2019K182785LOQTEQ VA Foot Plates 2.5HRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
November 23, 2016K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5HRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
November 22, 2016K161747LOQTEQ® 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 2.7/3.5HRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
November 4, 2016K161703LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, WasherHRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
January 21, 2016K153034aap LOQTEQ VA Radius Set 2.5HRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
April 29, 2015K150974aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, TitaniumHWCSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
September 12, 2014K141949CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUMHWCSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
August 7, 2014K141823AAP LOQTEC CLAVICLE PLATES 2.7/3.5HRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
May 8, 2014K140607AAP LOQTEC(R) OLECRANON PLATEHRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
January 23, 2014K133675AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5HRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
December 24, 2013K132787LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATEHRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
November 18, 2013K131782LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5HRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
October 17, 2013K131459AAP K-WIRE, STEINMANN PIN, CERCLAGE WIREJDWSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
October 3, 2013K132554AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5HRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
April 22, 2013K130590AAP CANNULATED SCREW 2.0HWCSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
March 11, 2013K123875AAP RADIUS SET 2.5HRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
December 7, 2012K121495LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONGHRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
November 19, 2012K121494LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPINGHRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
November 8, 2012K113601AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEMHRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
October 31, 2012K113602AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEMHRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
September 6, 2012K113648LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELFHRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
August 30, 2012K113652LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF THRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
July 20, 2011K111316AAP CANNULATED SCREWSHWCSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
March 25, 2008K080101AAP CANNULATED SCREW AND DARCO HEADED SCREWHWCSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
March 20, 2008K072411AAP BONE PLATES AND SCREW IMPLANTSHRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
August 29, 2007K071852AAP APS SYSTEMKTTSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
April 10, 2003K030909AAP ACROPLATEHRSSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
December 9, 2002K021233AAP CANNULATED SCREWSHWCSubstantially EquivalentAap Implantate AGaccessdata.fda.gov
April 29, 1999K990776AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MMHWCSubstantially EquivalentAap Implantate AGaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
November 28, 201984716Class IITerminatedaap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00The 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.accessdata.fda.gov
January 25, 201984383Class IIITerminatedINTEGRA, Drill CS 4.5, quick coupling single use, REF 430453Products were distributed with the incorrect instructions for use.accessdata.fda.gov
January 11, 201982159Class IITerminatedaap 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.There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.accessdata.fda.gov

Compare with other makers

Updated March 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.