| Device Type ID | 5717 |
| Device Name | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Regulation Description | Polytetrafluoroethylene With Carbon Fibers Composite Implant Material. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.3500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KKY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5717 |
| Device | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Product Code | KKY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Polytetrafluoroethylene With Carbon Fibers Composite Implant Material. |
| CFR Regulation Number | 878.3500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CEREMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MATRIX SURGICAL HOLDINGS, LLC/MATRIX SURGICAL USA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OXFORD PERFORMANCE MATERIALS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OXFORD PERFORMANCE MATERIALS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PORIFEROUS, LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Inadequacy Of Device Shape And/or Size | 14 |
Adverse Event Without Identified Device Or Use Problem | 14 |
Insufficient Information | 13 |
Fracture | 10 |
Fitting Problem | 6 |
Migration Or Expulsion Of Device | 5 |
Patient-Device Incompatibility | 5 |
Material Fragmentation | 4 |
Device Markings / Labelling Problem | 4 |
Appropriate Term/Code Not Available | 3 |
Break | 2 |
Crack | 2 |
Difficult To Position | 1 |
Noise, Audible | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Unsealed Device Packaging | 1 |
Device Packaging Compromised | 1 |
Loosening Of Implant Not Related To Bone-Ingrowth | 1 |
Screw | 1 |
Structural Problem | 1 |
Device Dislodged Or Dislocated | 1 |
| Total Device Problems | 91 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet Microfixation, LLC | II | Sep-08-2016 |
| 2 | Matrix Surgical Holdings, LLC | II | Feb-28-2017 |
| 3 | Stryker Howmedica Osteonics Corp. | II | Feb-12-2014 |