| Device Type ID | 4567 |
| Device Name | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Regulation Description | Elbow Joint Radial (hemi-elbow) Polymer Prosthesis. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3170 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KWI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4567 |
| Device | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Product Code | KWI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Elbow Joint Radial (hemi-elbow) Polymer Prosthesis. |
| CFR Regulation Number | 888.3170 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SKELETAL DYNAMICS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Unintended Movement | 171 |
Adverse Event Without Identified Device Or Use Problem | 85 |
Insufficient Information | 65 |
Migration Or Expulsion Of Device | 43 |
Device Slipped | 19 |
Loose Or Intermittent Connection | 19 |
Detachment Of Device Or Device Component | 17 |
Detachment Of Device Component | 13 |
Break | 11 |
Migration | 11 |
Loosening Of Implant Not Related To Bone-Ingrowth | 10 |
Device Operates Differently Than Expected | 9 |
Failure To Adhere Or Bond | 8 |
Device Dislodged Or Dislocated | 8 |
Appropriate Term/Code Not Available | 8 |
Unstable | 6 |
Patient-Device Incompatibility | 5 |
Fracture | 5 |
Mechanical Problem | 5 |
Component Missing | 4 |
Material Integrity Problem | 3 |
Malposition Of Device | 3 |
Fitting Problem | 3 |
Loss Of Osseointegration | 2 |
Inadequacy Of Device Shape And/or Size | 2 |
Material Separation | 2 |
Device Issue | 2 |
Material Erosion | 2 |
Difficult To Insert | 2 |
Naturally Worn | 2 |
Metal Shedding Debris | 2 |
Screw | 2 |
Loss Of Or Failure To Bond | 2 |
Disassembly | 1 |
Misassembled | 1 |
Connection Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Material Disintegration | 1 |
Difficult To Remove | 1 |
Failure To Osseointegrate | 1 |
Device Operational Issue | 1 |
Packaging Problem | 1 |
Material Rupture | 1 |
Material Fragmentation | 1 |
| Total Device Problems | 563 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Acumed LLC | II | May-31-2017 |
| 2 | Biomet, Inc. | II | May-13-2014 |
| 3 | Howmedica Osteonics Corp. | II | Aug-08-2018 |
| 4 | Skeletal Dynamics | II | Dec-12-2014 |
| 5 | Synthes (USA) Products LLC | II | Feb-02-2017 |
| 6 | Zimmer Biomet, Inc. | II | Dec-20-2017 |