| Device Type ID | 5192 |
| Device Name | Joint, Knee, External Brace |
| Regulation Description | Limb Orthosis. |
| 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 | 890.3475 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | ITQ |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5192 |
| Device | Joint, Knee, External Brace |
| Product Code | ITQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Limb Orthosis. |
| CFR Regulation Number | 890.3475 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 24 |
Patient Device Interaction Problem | 6 |
Patient-Device Incompatibility | 3 |
Device Operates Differently Than Expected | 2 |
Break | 2 |
Insufficient Information | 2 |
Missing Value Reason | 1 |
Hinge | 1 |
Off-Label Use | 1 |
Detachment Of Device Component | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Material Deformation | 1 |
Physical Resistance / Sticking | 1 |
Use Of Device Problem | 1 |
Component Missing | 1 |
Deformation Due To Compressive Stress | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 50 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Corflex | II | Jan-04-2016 |
| 2 | Ossur H / F | II | Mar-31-2016 |
| 3 | United Surgical Associates | II | May-23-2015 |