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Data / Medical devices / Germany / Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH

Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH: FDA-registered device maker in DUDERSTADT Lower Saxony, Germany, 3 510(k) clearances

Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH is registered with the FDA (registration 9616494) in DUDERSTADT Lower Saxony, Germany. It lists 39 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 22, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH
FDA registration number
9616494
FEI number
3003117657
Address
Max-Naeder-Strasse 15, DUDERSTADT Lower Saxony, Germany, D-37115
Owner or operator
Ottobock SE & Co. KGaA (8010097)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
First device listed
March 18, 1996
Registered through
2026
Brand names listed
3D L.A.S.A.R. Posture, 4-1 Option Lock Knee Joint, 4-Step Transducer, 7in1 Controller, AK Adapt Liner, AK Prosthetic Shrinker, AXON Tube Adapter, AXON Tube Adapter with Torsion and more

Devices it lists

DeviceProduct codeClassRoleSource
Band Or Belt, Pelvic SupportISR1Manufacturer, Specification developeraccessdata.fda.gov
Bandage, CastITG1Exporter to the US, Specification developeraccessdata.fda.gov
CaneIPS1Manufactureraccessdata.fda.gov
Component, External, Limb, Ankle/FootISH1Contract manufacturer, Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Cover, LimbIPM1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
CrutchIPR1Manufactureraccessdata.fda.gov
Device, Prosthesis AlignmentIQO1Manufacturer, Specification developeraccessdata.fda.gov
Electrode, CutaneousGXY2Exporter to the USaccessdata.fda.gov
Goniometer, Ac-PoweredKQX1Manufactureraccessdata.fda.gov
Hand, External Limb Component, MechanicalIRA1Manufacturer, Specification developeraccessdata.fda.gov
Hand, External Limb Component, PoweredIQZ1Exporter to the USaccessdata.fda.gov
Hook, External Limb Component, MechanicalIQX1Manufacturer, Specification developeraccessdata.fda.gov
Hook, External Limb Component, PoweredIQW1Exporter to the USaccessdata.fda.gov
Joint, Ankle, External BraceITW1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Joint, Elbow, External Limb Component, MechanicalIRD1Exporter to the US, Manufactureraccessdata.fda.gov
Joint, Elbow, External Limb Component, PoweredIRE1Exporter to the US, Manufactureraccessdata.fda.gov
Joint, Hip, External BraceITS1Manufacturer, Specification developeraccessdata.fda.gov
Joint, Hip, External Limb ComponentISL1Manufacturer, Specification developeraccessdata.fda.gov
Joint, Knee, External BraceITQ1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Joint, Knee, External Limb ComponentISY1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Joint, Shoulder, External Limb ComponentIQQ1Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, CervicalIQK1Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Corrective ShoeKNP1Manufactureraccessdata.fda.gov
Orthosis, Limb BraceIQI1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, LumbarIQE1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Lumbo-SacralIPY1Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Sacroiliac, SoftIPW1Exporter to the US, Specification developeraccessdata.fda.gov
Orthosis, ThoracicIPT1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Orthosis, Truncal/Orthosis, LimbMRI1Manufacturer, Specification developeraccessdata.fda.gov
Platform, Force-MeasuringKHX1Manufactureraccessdata.fda.gov
Prosthesis, Thigh Socket, External ComponentISS1Manufacturer, Specification developeraccessdata.fda.gov
Sling, Arm, Overhead SupportedILE1Manufacturer, Specification developeraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Manufacturer, Specification developeraccessdata.fda.gov
Stirrup, External Brace ComponentITC1Manufacturer, Specification developeraccessdata.fda.gov
Support, ArmIOY1Manufacturer, Specification developeraccessdata.fda.gov
Support, HerniaEXN1Manufactureraccessdata.fda.gov
Unit, Wrist, External Limb Component, MechanicalISZ1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Unit, Wrist, External Limb Component, PoweredKGH1Exporter to the USaccessdata.fda.gov
Valve, ProsthesisISP1Manufacturer, Specification developeraccessdata.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
April 22, 2026K253256myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)GXYSubstantially EquivalentOtto Bock Healthcare Products GmbHaccessdata.fda.gov
September 4, 2019K191179Myo PlusGXYSubstantially EquivalentOtto Bock Healthcare Products GmbHaccessdata.fda.gov
June 3, 2014K123795AXON-BUS PROSTHETIC SYSTEMGXYSubstantially EquivalentOtto Bock Austriaaccessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
January 4, 201672960Class IITerminatedOttobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced between 27 April 2015 and 17 November 2015 due to a service error where the wrong Loctite was used during repair.accessdata.fda.gov
October 23, 201572488Class IITerminatediOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall. When sitting, the prosthetic foot can go into the Relief Function to move the footplate towards the ground. When operating machines with foot pedals (e.g. a car) the foot could get stuck under the foot pedal and block it or, with the foot on the pedal, it could accessdata.fda.gov
July 16, 201571715Class IITerminatedOttobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other componeOtto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014 because the locking function may fail under certain conditions which may result in a fall.accessdata.fda.gov

Compare with other makers

Updated April 22, 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.