| Device Type ID | 4468 |
| Device Name | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Regulation Description | Shoulder Joint Humeral (hemi-shoulder) Metallic Uncemented 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 | 888.3690 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HSD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4468 |
| Device | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Product Code | HSD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Shoulder Joint Humeral (hemi-shoulder) Metallic Uncemented Prosthesis. |
| CFR Regulation Number | 888.3690 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ARTHREX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ARTHROCARE CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARTHROSURFACE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 858 |
Device Dislodged Or Dislocated | 502 |
Adverse Event Without Identified Device Or Use Problem | 230 |
Appropriate Term/Code Not Available | 133 |
Break | 133 |
Fracture | 107 |
Loss Of Osseointegration | 100 |
Migration Or Expulsion Of Device | 90 |
Disassembly | 76 |
Unstable | 55 |
Naturally Worn | 47 |
Loss Of Or Failure To Bond | 40 |
Failure To Adhere Or Bond | 38 |
Fitting Problem | 32 |
Malposition Of Device | 31 |
Loose Or Intermittent Connection | 30 |
Difficult To Insert | 26 |
Detachment Of Device Component | 23 |
Detachment Of Device Or Device Component | 18 |
Inadequacy Of Device Shape And/or Size | 15 |
Difficult To Remove | 15 |
Mechanical Jam | 12 |
Metal Shedding Debris | 10 |
Connection Problem | 9 |
Device Operates Differently Than Expected | 9 |
Osseointegration Problem | 9 |
Material Deformation | 9 |
Material Erosion | 9 |
Positioning Problem | 9 |
Loosening Of Implant Not Related To Bone-Ingrowth | 8 |
Material Separation | 8 |
Misconnection | 8 |
Migration | 7 |
Failure To Osseointegrate | 7 |
Component Missing | 7 |
Mechanical Problem | 7 |
Noise, Audible | 6 |
Defective Component | 6 |
Bent | 5 |
Unintended System Motion | 5 |
Separation Problem | 5 |
Packaging Problem | 5 |
Device Markings / Labelling Problem | 5 |
Device-Device Incompatibility | 4 |
Device Slipped | 3 |
Misassembled | 3 |
Compatibility Problem | 3 |
Failure To Advance | 3 |
Tear, Rip Or Hole In Device Packaging | 2 |
Difficult Or Delayed Positioning | 2 |
Use Of Device Problem | 2 |
Device Abrasion From Instrument Or Another Object | 2 |
Defective Device | 2 |
Crack | 2 |
Dull, Blunt | 2 |
Scratched Material | 2 |
Component Incompatible | 2 |
Material Fragmentation | 2 |
Incomplete Or Missing Packaging | 1 |
Separation Failure | 1 |
Plate | 1 |
Incorrect Device Or Component Shipped | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Peeled / Delaminated | 1 |
Unintended Movement | 1 |
Disconnection | 1 |
Entrapment Of Device | 1 |
Difficult To Position | 1 |
Split | 1 |
Torn Material | 1 |
Thread | 1 |
Particulates | 1 |
Tip | 1 |
Deformation Due To Compressive Stress | 1 |
Delamination | 1 |
Screw | 1 |
Incorrect Measurement | 1 |
Decoupling | 1 |
Electronic Property Issue | 1 |
Material Disintegration | 1 |
Pitted | 1 |
Device Operational Issue | 1 |
| Total Device Problems | 2824 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arthrosurface, Inc. | II | Feb-12-2015 |
| 2 | Ascension Orthopedics, Inc | III | Feb-02-2019 |
| 3 | DePuy Orthopaedics, Inc. | II | Mar-01-2018 |
| 4 | Fx Solutions | II | Jul-17-2018 |
| 5 | Limacorporate S.p.A | II | Sep-02-2015 |
| 6 | Zimmer Biomet, Inc. | II | Mar-13-2018 |