FDA product code JDX: Instrument, Surgical, Sonic And Accessory/Attachment
JDX is the FDA product code for instrument, surgical, sonic and accessory/attachment. It is a Class II device, regulated under 21 CFR 888.4580 and reviewed by the Orthopedic panel. FDA has cleared 23 510(k) submissions under JDX, from 18 different applicants. The average 510(k) review took 111 days (median 90). FDA has posted 2 recalls for JDX devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Surgical, Sonic And Accessory/Attachment |
| Device class | Class II |
| Regulation | 21 CFR 888.4580 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
510(k) clearances per year for JDX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 148 |
| 2018 | 1 | 253 |
| 2021 | 1 | 283 |
Compare with all 510(k) review times · Search every JDX clearance
Top JDX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthosonics, Ltd. | 3 | 2010-02-19 |
| Mectron S.P.A. | 2 | 2016-05-25 |
| Buckman Co., Inc. | 2 | 1991-10-03 |
| Advanced Osseous Technologies | 2 | 1991-03-05 |
| Smtp Technology Co., Ltd. | 1 | 2021-02-19 |
13 more applicants have JDX clearances. See the full list in Caduvo.
Most recent JDX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201274 | Smtp Technology Co., Ltd. | Ultrasonic Osteotomy Surgical System | 2021-02-19 | 283 |
| K172464 | Morley Research Consortium | XD880A Ultrasonic Osteotomy Surgical System | 2018-04-24 | 253 |
| K163610 | Satalec-Acteon Group | PIEZOTOME M+, PIEZOTOME M+ Handpiece | 2017-05-19 | 148 |
| K153743 | Mectron S.P.A. | PIEZOSURGERY PLUS | 2016-05-25 | 149 |
| K132848 | Mectron S.P.A. | PIEZOSURGERY FLEX | 2013-11-29 | 79 |
Recalls for JDX devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-06-04.
| Year | Recalls |
|---|---|
| 2019 | 2 |
Frequently asked questions
What is FDA product code JDX?
JDX is the FDA product code for instrument, surgical, sonic and accessory/attachment. It is a Class II device, regulated under 21 CFR 888.4580 and reviewed by the Orthopedic panel.
What device class is JDX?
Class II, regulation 21 CFR 888.4580. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JDX?
Across 23 cleared submissions the average was 111 days from receipt to decision (median 90).
Which companies have the most JDX clearances?
Orthosonics, Ltd. (3); Mectron S.P.A. (2); Buckman Co., Inc. (2); Advanced Osseous Technologies (2); Smtp Technology Co., Ltd. (1).
Have JDX devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2019-06-04.
Next steps
- Run an FDA pathway report with predicate devices for product code JDX
- Run a recall and safety report across every JDX manufacturer
- Watch product code JDX 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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