FDA product code JEC: Component, Traction, Invasive
JEC is the FDA product code for component, traction, invasive. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel. FDA has cleared 85 510(k) submissions under JEC, from 51 different applicants. The average 510(k) review took 96 days (median 64). FDA has posted 6 recalls for JEC devices.
Classification
| Field | Value |
|---|---|
| Device name | Component, Traction, Invasive |
| Device class | Class II |
| Regulation | 21 CFR 888.3040 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for JEC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 220 |
| 2019 | 1 | 31 |
| 2020 | 1 | 97 |
| 2021 | 1 | 134 |
Compare with all 510(k) review times · Search every JEC clearance
Top JEC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Howmedica Corp. | 11 | 1997-07-17 |
| Ace Orthopedic Manufacturing Co. | 5 | 1994-02-22 |
| Hand Biomechanics Lab, Inc. | 4 | 2018-10-22 |
| Synthes (Usa) | 4 | 2007-08-24 |
| Acu Med, Inc. | 3 | 1997-02-19 |
46 more applicants have JEC clearances. See the full list in Caduvo.
Most recent JEC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203605 | Arbutus Medical, Inc. | SteriTrak | 2021-04-23 | 134 |
| K193256 | Anjon Holdings, LLC | Anjon Bremer Halo System | 2020-03-02 | 97 |
| K192465 | Virak Orthopedics, LLC | DigiFix Sterile Kit | 2019-10-10 | 31 |
| K181192 | Hand Biomechanics Lab, Inc. | PIP Fix | 2018-10-22 | 171 |
| K171863 | Anjon Holdings, LLC | Anjon Bremer Halo System | 2018-03-19 | 270 |
Recalls for JEC devices
6 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-06-18.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code JEC?
JEC is the FDA product code for component, traction, invasive. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel.
What device class is JEC?
Class II, regulation 21 CFR 888.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code JEC?
Across 85 cleared submissions the average was 96 days from receipt to decision (median 64).
Which companies have the most JEC clearances?
Howmedica Corp. (11); Ace Orthopedic Manufacturing Co. (5); Hand Biomechanics Lab, Inc. (4); Synthes (Usa) (4); Acu Med, Inc. (3).
Have JEC devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2020-06-18.
Next steps
- Run an FDA pathway report with predicate devices for product code JEC
- Run a recall and safety report across every JEC manufacturer
- Watch product code JEC 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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