FDA product code KKY: Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
KKY is the FDA product code for material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction. It is a Class II device, regulated under 21 CFR 878.3500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 25 510(k) submissions under KKY, from 22 different applicants. The average 510(k) review took 164 days (median 141). FDA has posted 9 recalls for KKY devices.
Classification
| Field | Value |
|---|---|
| Device name | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Device class | Class II |
| Regulation | 21 CFR 878.3500 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KKY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 59 |
Top KKY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ceremed , Inc. | 4 | 2016-07-14 |
| Longeviti Neuro Solutions, LLC | 1 | 2021-07-15 |
| Oxford Performance Materials, Inc. | 1 | 2016-07-20 |
| Oxford Performance Materials | 1 | 2014-07-28 |
| Poriferous, LLC | 1 | 2014-06-13 |
17 more applicants have KKY clearances. See the full list in Caduvo.
Most recent KKY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K211514 | Longeviti Neuro Solutions, LLC | Longeviti PorousFit implant | 2021-07-15 | 59 |
| K161052 | Oxford Performance Materials, Inc. | OsteoFab Patient Specific Facial Device | 2016-07-20 | 97 |
| K160988 | Ceremed , Inc. | Biopor, AOC Porous Polyethylene, Cerepor | 2016-07-14 | 97 |
| K141880 | Ceremed , Inc. | BIOPOR AOC POROUS POLYETHYLENE, CEREPOR | 2015-04-16 | 279 |
| K133809 | Oxford Performance Materials | OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE | 2014-07-28 | 224 |
Recalls for KKY devices
9 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-01-30.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 2 |
Frequently asked questions
What is FDA product code KKY?
KKY is the FDA product code for material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction. It is a Class II device, regulated under 21 CFR 878.3500 and reviewed by the General and Plastic Surgery panel.
What device class is KKY?
Class II, regulation 21 CFR 878.3500. Typical premarket route: 510(k).
How long does a 510(k) take for product code KKY?
Across 25 cleared submissions the average was 164 days from receipt to decision (median 141).
Which companies have the most KKY clearances?
Ceremed , Inc. (4); Longeviti Neuro Solutions, LLC (1); Oxford Performance Materials, Inc. (1); Oxford Performance Materials (1); Poriferous, LLC (1).
Have KKY devices been recalled?
Yes: 9 product recalls across 5 recall events; the most recent began 2019-01-30.
Next steps
- Run an FDA pathway report with predicate devices for product code KKY
- Run a recall and safety report across every KKY manufacturer
- Watch product code KKY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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