| Device Type ID | 4578 |
| Device Name | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Regulation Description | Shoulder Joint Metal/polymer Non-constrained Cemented 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 | 888.3650 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KWT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4578 |
| Device | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Product Code | KWT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Shoulder Joint Metal/polymer Non-constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3650 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CATALYST ORTHOSCIENCE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EXACTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FX SOLUTIONS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIMACORPORATE S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 232 |
Insufficient Information | 164 |
Device Dislodged Or Dislocated | 61 |
Migration Or Expulsion Of Device | 52 |
Fracture | 42 |
Unstable | 24 |
Detachment Of Device Component | 23 |
Naturally Worn | 22 |
Loss Of Or Failure To Bond | 16 |
Difficult To Insert | 13 |
Mechanical Jam | 12 |
Detachment Of Device Or Device Component | 10 |
Appropriate Term/Code Not Available | 9 |
Break | 8 |
Malposition Of Device | 8 |
Loosening Of Implant Not Related To Bone-Ingrowth | 8 |
Unintended Movement | 6 |
Loose Or Intermittent Connection | 6 |
Difficult To Remove | 6 |
Failure To Adhere Or Bond | 5 |
Joint | 5 |
Separation Failure | 5 |
Material Fragmentation | 4 |
Loss Of Osseointegration | 4 |
Device Slipped | 4 |
Noise, Audible | 4 |
Disassembly | 4 |
Difficult To Position | 3 |
Material Erosion | 3 |
Manufacturing, Packaging Or Shipping Problem | 2 |
Device-Device Incompatibility | 2 |
Material Deformation | 2 |
Misassembly By Users | 2 |
No Apparent Adverse Event | 2 |
Screw | 2 |
Component Missing | 2 |
Difficult Or Delayed Separation | 2 |
Unintended System Motion | 2 |
Connection Problem | 2 |
Migration | 2 |
Failure To Advance | 2 |
Device Operates Differently Than Expected | 2 |
Device Operational Issue | 2 |
Bent | 1 |
Pitted | 1 |
Compatibility Problem | 1 |
Material Integrity Problem | 1 |
Osseointegration Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Shaft | 1 |
Use Of Device Problem | 1 |
Metal Shedding Debris | 1 |
Device Damaged By Another Device | 1 |
Material Protrusion / Extrusion | 1 |
Fitting Problem | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Device Damaged Prior To Use | 1 |
Dull, Blunt | 1 |
Failure To Align | 1 |
Defective Device | 1 |
Packaging Problem | 1 |
| Total Device Problems | 810 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Exactech, Inc. | II | Oct-03-2018 |
| 2 | Exactech, Inc. | II | Dec-22-2016 |
| 3 | Limacorporate S.p.A | II | Sep-02-2015 |
| 4 | Zimmer Biomet, Inc. | II | Mar-23-2018 |
| 5 | Zimmer Biomet, Inc. | II | Dec-29-2017 |
| 6 | Zimmer Biomet, Inc. | II | Sep-22-2017 |
| 7 | Zimmer, Inc. | II | Feb-26-2014 |
| 8 | Zimmer, Inc. | II | Feb-24-2014 |