FDA product code JOF: Polymer, Ent Synthetic, Porous Polyethylene
JOF is the FDA product code for polymer, ent synthetic, porous polyethylene. It is a Class II device, regulated under 21 CFR 874.3620 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 6 510(k) submissions under JOF, from 4 different applicants. The average 510(k) review took 88 days (median 73).
Classification
| Field | Value |
|---|---|
| Device name | Polymer, Ent Synthetic, Porous Polyethylene |
| Device class | Class II |
| Regulation | 21 CFR 874.3620 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for JOF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 265 |
| 2020 | 1 | 92 |
Compare with all 510(k) review times · Search every JOF clearance
Top JOF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Anatomics Pty, Ltd. | 2 | 2020-06-02 |
| Xomed, Inc. | 2 | 1977-09-26 |
| Porex Surgical, Inc. | 1 | 2009-02-03 |
| Pillar Surgical, Inc. | 1 | 2000-11-20 |
Most recent JOF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200532 | Anatomics Pty, Ltd. | StarPore | 2020-06-02 | 92 |
| K171037 | Anatomics Pty, Ltd. | PoreStar Patient Specific Implant | 2017-12-27 | 265 |
| K083621 | Porex Surgical, Inc. | MEDPOR CUSTOMIZED SURGICAL IMPLANT | 2009-02-03 | 57 |
| K002629 | Pillar Surgical, Inc. | SILMAX CONTOUR CARVING BLOCK IMPLANT | 2000-11-20 | 89 |
| K771726 | Xomed, Inc. | BIOSPONGE STAPES PISTON | 1977-09-26 | 13 |
Recalls for JOF devices
openFDA lists no recalls for product code JOF.
Frequently asked questions
What is FDA product code JOF?
JOF is the FDA product code for polymer, ent synthetic, porous polyethylene. It is a Class II device, regulated under 21 CFR 874.3620 and reviewed by the Ear, Nose and Throat panel.
What device class is JOF?
Class II, regulation 21 CFR 874.3620. Typical premarket route: 510(k).
How long does a 510(k) take for product code JOF?
Across 6 cleared submissions the average was 88 days from receipt to decision (median 73).
Which companies have the most JOF clearances?
Anatomics Pty, Ltd. (2); Xomed, Inc. (2); Porex Surgical, Inc. (1); Pillar Surgical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JOF
- Run a recall and safety report across every JOF manufacturer
- Watch product code JOF 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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