Definition: Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotato
| Device Type ID | 4683 |
| Device Name | Shoulder Prosthesis, Reverse Configuration |
| Physical State | Typically Includes Humeral Stem, Humeral Socket, Humeral Cup, Glenosphere, And Glenoid Baseplate With Fixation Screws. The Humeral Stem And Humeral Socket May Be One Single Piece Or Two Separate Pieces Locked Together. The Humeral Cup Is Snap Fit Int |
| Technical Method | Relative To The Native Shoulder Joint, The Device Moves The Center Of Rotation Medially And Distally To The Anatomic Position Which Increases The Length Of The Deltoid Muscle's Lever Arm, Allowing The Same Rotational Moment With Less Applied Force. |
| Target Area | Shoulder Joint |
| Regulation Description | Shoulder Joint Metal/polymer Semi-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 | 888.3660 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PHX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4683 |
| Device | Shoulder Prosthesis, Reverse Configuration |
| Product Code | PHX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Shoulder Joint Metal/polymer Semi-constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3660 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ARTHREX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ENCORE MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ENCORE MEDICAL, L.P. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EXACTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
FOURNITURES HOSPITALIERES | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
FOURNITURES HOSPITALIERES INDUSTRIE | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
FX SOLUTIONS | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
INTEGRA | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
INTEGRA LIFESCIENCES CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
LIMACORPORATE S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDACTA INTERNATIONAL SA | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
TORNIER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TORNIER INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
ZIMMER GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 17 |
Device Dislodged Or Dislocated | 12 |
Fracture | 9 |
Material Integrity Problem | 8 |
Positioning Problem | 7 |
Insufficient Information | 6 |
Migration Or Expulsion Of Device | 6 |
Detachment Of Device Or Device Component | 5 |
Device Slipped | 4 |
Device Operates Differently Than Expected | 4 |
Unintended Movement | 3 |
Material Deformation | 2 |
Naturally Worn | 2 |
Break | 1 |
Difficult To Insert | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Fitting Problem | 1 |
Mechanical Jam | 1 |
Device Operational Issue | 1 |
Difficult To Remove | 1 |
Appropriate Term/Code Not Available | 1 |
Component Missing | 1 |
| Total Device Problems | 94 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Encore Medical, Lp | II | Mar-05-2018 |
| 2 | Encore Medical, Lp | II | Jan-09-2016 |
| 3 | Encore Medical, Lp | II | Oct-16-2015 |
| 4 | Exactech, Inc. | II | Feb-26-2019 |