| Device Type ID | 5182 |
| Device Name | Joint, Knee, External Limb Component |
| Regulation Description | External Limb Prosthetic Component. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Physical Medicine |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 890.3420 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | ISY |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5182 |
| Device | Joint, Knee, External Limb Component |
| Product Code | ISY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | External Limb Prosthetic Component. |
| CFR Regulation Number | 890.3420 [🔎] |
| Device Problems | |
|---|---|
Mechanical Problem | 72 |
Device Operates Differently Than Expected | 59 |
Device Handling Problem | 20 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Failure To Service | 2 |
Improper Or Incorrect Procedure Or Method | 1 |
Human Factors Issue | 1 |
Insufficient Information | 1 |
Positioning Problem | 1 |
| Total Device Problems | 162 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Otto Bock Healthcare GmbH | II | Feb-01-2016 |
| 2 | Otto Bock Healthcare GmbH | II | Jul-24-2015 |
| 3 | Otto Bock Healthcare Product | II | Mar-01-2018 |
| 4 | Ottobock Orthopedic Industrie | II | Feb-13-2019 |