| Device Type ID | 4596 |
| Device Name | Bone Cement |
| Regulation Description | Polymethylmethacrylate (PMMA) Bone Cement. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Restorative And Repair Devices Branch (RRDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3027 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LOD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4596 |
| Device | Bone Cement |
| Product Code | LOD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Polymethylmethacrylate (PMMA) Bone Cement. |
| CFR Regulation Number | 888.3027 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMET | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIOMET INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMET INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KULZER, LLC | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
SYNTHES (USA) PRODUCTS LLC / MEDICAL DEVICE BUSINESS SERVICE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Loss Of Or Failure To Bond | 1448 |
Insufficient Information | 355 |
Loose Or Intermittent Connection | 236 |
Adverse Event Without Identified Device Or Use Problem | 150 |
Loss Of Osseointegration | 149 |
Appropriate Term/Code Not Available | 147 |
Migration Or Expulsion Of Device | 106 |
Failure To Adhere Or Bond | 92 |
Break | 68 |
Loosening Of Implant Not Related To Bone-Ingrowth | 67 |
Device Operates Differently Than Expected | 65 |
Packaging Problem | 51 |
Unsealed Device Packaging | 37 |
Infusion Or Flow Problem | 37 |
Improper Chemical Reaction | 33 |
Manufacturing, Packaging Or Shipping Problem | 31 |
Shipping Damage Or Problem | 26 |
Tear, Rip Or Hole In Device Packaging | 24 |
Fracture | 22 |
Device Difficult To Setup Or Prepare | 22 |
Device Damaged Prior To Use | 21 |
Device Packaging Compromised | 20 |
Unstable | 17 |
Device Emits Odor | 16 |
Leak / Splash | 16 |
Defective Device | 16 |
Use Of Device Problem | 15 |
Migration | 11 |
Device Contamination With Chemical Or Other Material | 10 |
Device Handling Problem | 9 |
Osseointegration Problem | 9 |
Device Dislodged Or Dislocated | 9 |
Delivered As Unsterile Product | 8 |
Device Slipped | 8 |
Difficult To Open Or Remove Packaging Material | 7 |
Device Contaminated During Manufacture Or Shipping | 7 |
Material Deformation | 6 |
Fluid Leak | 6 |
Noise, Audible | 5 |
Naturally Worn | 5 |
Moisture Or Humidity Problem | 5 |
Physical Resistance / Sticking | 5 |
Disassembly | 5 |
Material Integrity Problem | 5 |
Improper Or Incorrect Procedure Or Method | 5 |
Clumping In Device Or Device Ingredient | 5 |
Patient-Device Incompatibility | 4 |
Chemical Problem | 4 |
Inadequate Or Insufficient Training | 4 |
Crack | 4 |
Device Expiration Issue | 3 |
Mechanical Problem | 3 |
Malposition Of Device | 3 |
Material Too Rigid Or Stiff | 3 |
Application Program Problem | 3 |
Sticking | 3 |
Failure To Unwrap | 3 |
Contamination During Use | 3 |
Material Discolored | 3 |
Failure To Advance | 2 |
Device Ingredient Or Reagent Problem | 2 |
Expiration Date Error | 2 |
Optical Discoloration | 2 |
Device Operational Issue | 2 |
Component Missing | 2 |
Failure To Eject | 2 |
Contamination Of Device Ingredient Or Reagent | 2 |
Detachment Of Device Component | 2 |
Off-Label Use | 2 |
Material Fragmentation | 2 |
Use Of Incorrect Control Settings | 2 |
Incomplete Or Missing Packaging | 2 |
Sharp Edges | 2 |
Positioning Problem | 2 |
Disconnection | 2 |
Difficult To Insert | 2 |
Torn Material | 2 |
Shelf Life Exceeded | 1 |
Improper Flow Or Infusion | 1 |
Charred | 1 |
Material Perforation | 1 |
Failure To Align | 1 |
Split | 1 |
Difficult Or Delayed Activation | 1 |
Scratched Material | 1 |
Component Falling | 1 |
Device Markings / Labelling Problem | 1 |
Fumes Or Vapors | 1 |
Separation Failure | 1 |
Out-Of-Box Failure | 1 |
Patient Device Interaction Problem | 1 |
Mechanical Jam | 1 |
Positioning Failure | 1 |
Material Separation | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Fitting Problem | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Material Split, Cut Or Torn | 1 |
No Flow | 1 |
Physical Property Issue | 1 |
| Total Device Problems | 3519 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Encore Medical, Lp | II | Nov-06-2017 |
| 2 | Encore Medical, Lp | II | Aug-19-2016 |
| 3 | Stryker Instruments Div. Of Stryker Corporation | II | Mar-28-2018 |
| 4 | Zimmer Biomet, Inc. | II | Apr-25-2017 |
| 5 | Zimmer, Inc. | II | Dec-31-2014 |