FDA product code JDO: Device, Fixation, Proximal Femoral, Implant
JDO is the FDA product code for device, fixation, proximal femoral, implant. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 23 510(k) submissions under JDO, 2 in the last five years, from 12 different applicants. The average 510(k) review took 115 days (median 84). FDA has posted 8 recalls for JDO devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Fixation, Proximal Femoral, Implant |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for JDO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 98 |
| 2018 | 1 | 51 |
| 2020 | 1 | 121 |
| 2021 | 1 | 91 |
| 2022 | 1 | 367 |
| 2023 | 1 | 29 |
Compare with all 510(k) review times · Search every JDO clearance
Top JDO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Synthes (Usa) | 5 | 1998-07-17 |
| Biomet, Inc. | 4 | 2018-02-07 |
| Smith & Nephew, Inc. | 3 | 2022-09-29 |
| Smith & Nephew | 2 | 2017-12-22 |
| Stelkast Company | 2 | 1994-03-10 |
7 more applicants have JDO clearances. See the full list in Caduvo.
Most recent JDO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230764 | OsteoCentric Technologies | OsteoCentric Integrated Hip Fastener System | 2023-04-18 | 29 |
| K213126 | Smith & Nephew, Inc. | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws | 2022-09-29 | 367 |
| K210247 | Osteocentric Technologies D.B.A. Osteocentric Trauma | OsteoCentric Integrated Hip Fastener System | 2021-04-30 | 91 |
| K193029 | Smith & Nephew, Inc. | CONQUEST FN | 2020-02-28 | 121 |
| K173826 | Biomet, Inc. | THP Hip Fracture Plating System | 2018-02-07 | 51 |
Recalls for JDO devices
8 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-01-07.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 4 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code JDO?
JDO is the FDA product code for device, fixation, proximal femoral, implant. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is JDO?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code JDO?
Across 23 cleared submissions the average was 115 days from receipt to decision (median 84).
Which companies have the most JDO clearances?
Synthes (Usa) (5); Biomet, Inc. (4); Smith & Nephew, Inc. (3); Smith & Nephew (2); Stelkast Company (2).
Have JDO devices been recalled?
Yes: 8 product recalls across 5 recall events; the most recent began 2020-01-07.
Next steps
- Run an FDA pathway report with predicate devices for product code JDO
- Run a recall and safety report across every JDO manufacturer
- Watch product code JDO 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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