Otto Bock Healthcare Products GmbH
Vienna Wien, AT
Otto Bock Healthcare Products GmbH appears in FDA device records in Vienna Wien, AT. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Otto Bock Healthcare Products GmbH carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Otto Bock Healthcare Productenforcement report, recall
510(k) clearance history
FDA records hold 3 510(k) clearances for Otto Bock Healthcare Products GmbH between 2015 and 2026. The busiest year on record is 2015, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2019 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | GXY | Substantially Equivalent | |
| K191179 | Myo Plus | GXY | Substantially Equivalent | |
| K141812 | MYGAIT STIMULATION SYSTEM | GZI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005190268 | 3005190268 | Otto Bock Healthcare Products GmbH | Brehmstrasse 16, Vienna Wien A-1110 AT | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ITGBandage, Cast
- ISHComponent, External, Limb, Ankle/Foot
- IPMCover, Limb
- IQODevice, Prosthesis Alignment
- GXYElectrode, Cutaneous
- IQZHand, External Limb Component, Powered
- IQWHook, External Limb Component, Powered
- IRDJoint, Elbow, External Limb Component, Mechanical
- IREJoint, Elbow, External Limb Component, Powered
- ITQJoint, Knee, External Brace
- ISYJoint, Knee, External Limb Component
- IQIOrthosis, Limb Brace
- ISSProsthesis, Thigh Socket, External Component
- GZIStimulator, Neuromuscular, External Functional
- ISZUnit, Wrist, External Limb Component, Mechanical
- KGHUnit, Wrist, External Limb Component, Powered
- ISPValve, Prosthesis
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0815-2018 | OTTO BOCK Kenevo knee joints Model 3C60=ST | 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 according to the labeled torque specification, AND the patient weighs at most 125kg it may be remote that the pylon breaks, and causing the patient to fall. There have been no failures or complaints reported directly attributed to the failure mode collapsed pylon. In the US Market and in Canada, labeling requires a condition based service at three years. In the rest of the world, a mandatory two year service interval is specified. Only the devices in distribution in the United States and Canada are affected by this action. | Class II | Terminated | |
| Z-0814-2018 | 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 according to the labeled torque specification, AND the patient weighs at most 125kg it may be remote that the pylon breaks, and causing the patient to fall. There have been no failures or complaints reported directly attributed to the failure mode collapsed pylon. In the US Market and in Canada, labeling requires a condition based service at three years. In the rest of the world, a mandatory two year service interval is specified. Only the devices in distribution in the United States and Canada are affected by this action. | Class II | Terminated | |
| Z-2438-2015 | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain