Data / Medical devices / Austria / Otto Bock Healthcare Products GmbH
Otto Bock Healthcare Products GmbH: FDA-registered device maker in Vienna Wien, Austria, 3 510(k) clearances
Otto Bock Healthcare Products GmbH is registered with the FDA (registration 3005190268) in Vienna Wien, Austria. It lists 16 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 22, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005190268
- Address
- Brehmstrasse 16, Vienna Wien, Austria, A-1110
- Owner or operator
- Ottobock SE & Co. KGaA (8010097)
- Roles
- Manufacturer
- First device listed
- December 29, 2004
- Registered through
- 2026
- Brand names listed
- 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, Acro ComforT and more
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 22, 2026 | K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | GXY | Substantially Equivalent | Otto Bock Healthcare Products GmbH | accessdata.fda.gov |
| September 4, 2019 | K191179 | Myo Plus | GXY | Substantially Equivalent | Otto Bock Healthcare Products GmbH | accessdata.fda.gov |
| June 3, 2014 | K123795 | AXON-BUS PROSTHETIC SYSTEM | GXY | Substantially Equivalent | Otto Bock Austria | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 12, 2017 | 79019 | Class II | Terminated | OTTO BOCK Kenevo knee joints Model 3C60 | Otto Bock Healthcare Products GmbH has identified a design issue through extended durability testing where the pylon clamping mechanism has the potential to cause damage to the pylon. When used longer than 1.45 million cycles (which represents approximately 2.3 years of use of the knee joint under heavy usage conditions), AND the pylon clamp is overtightened | accessdata.fda.gov |
| August 12, 2015 | 71950 | Class II | Terminated | Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings. | Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the resistance-control of the hydraulics, which may fail under conditions. | accessdata.fda.gov |
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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.