| Device Type ID | 4521 |
| Device Name | Prosthesis, Elbow, Constrained, Cemented |
| Regulation Description | Elbow Joint Metal/polymer 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 | 888.3150 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JDC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4521 |
| Device | Prosthesis, Elbow, Constrained, Cemented |
| Product Code | JDC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Elbow Joint Metal/polymer Constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3150 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIMACORPORATE S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Insufficient Information | 271 |
Migration Or Expulsion Of Device | 114 |
Fracture | 63 |
Adverse Event Without Identified Device Or Use Problem | 35 |
Device Dislodged Or Dislocated | 32 |
Appropriate Term/Code Not Available | 27 |
Naturally Worn | 26 |
Packaging Problem | 18 |
Device Markings / Labelling Problem | 18 |
Failure To Adhere Or Bond | 18 |
Break | 17 |
Loose Or Intermittent Connection | 15 |
Difficult To Insert | 13 |
Migration | 12 |
Unstable | 12 |
Malposition Of Device | 11 |
Detachment Of Device Component | 10 |
Disassembly | 8 |
Component Missing | 7 |
Difficult To Position | 7 |
Inadequacy Of Device Shape And/or Size | 6 |
Pin | 6 |
Loss Of Or Failure To Bond | 5 |
Material Deformation | 5 |
Loosening Of Implant Not Related To Bone-Ingrowth | 4 |
Detachment Of Device Or Device Component | 4 |
Difficult To Remove | 4 |
Metal Shedding Debris | 3 |
Mechanical Problem | 3 |
Noise, Audible | 3 |
Material Erosion | 3 |
Hinge | 2 |
Difficult To Advance | 2 |
Device Slipped | 2 |
Physical Resistance / Sticking | 2 |
Fitting Problem | 2 |
Device Operates Differently Than Expected | 2 |
Misconnection | 2 |
Failure To Advance | 1 |
Material Integrity Problem | 1 |
Osseointegration Problem | 1 |
Device Operational Issue | 1 |
Particulates | 1 |
Difficult Or Delayed Positioning | 1 |
Loss Of Osseointegration | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Unclear Information | 1 |
Component Incompatible | 1 |
Off-Label Use | 1 |
Separation Failure | 1 |
Device Damaged By Another Device | 1 |
Mechanical Jam | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Biocompatibility | 1 |
Bushing | 1 |
| Total Device Problems | 811 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet, Inc. | II | Jun-26-2014 |
| 2 | Zimmer Biomet, Inc. | II | Mar-14-2018 |
| 3 | Zimmer Biomet, Inc. | II | Sep-08-2016 |