FDA product code JDK: Prosthesis, Hip, Cement Restrictor
JDK is the FDA product code for prosthesis, hip, cement restrictor. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Orthopedic panel. FDA has cleared 54 510(k) submissions under JDK, from 36 different applicants. The average 510(k) review took 106 days (median 84). FDA has posted 12 recalls for JDK devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Cement Restrictor |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | OR — Orthopedic |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for JDK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 87 |
Compare with all 510(k) review times · Search every JDK clearance
Top JDK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Osteonics Corp. | 6 | 1997-02-28 |
| Spinal Concepts, Inc. | 5 | 2003-08-22 |
| Medtronic Sofamor Danek, Inc. | 5 | 2001-12-05 |
| Life Spine | 2 | 2006-07-12 |
| Spine Next SA | 2 | 2003-12-22 |
31 more applicants have JDK clearances. See the full list in Caduvo.
Most recent JDK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K210062 | Medacta International S.A. | Mectaplug PE II | 2021-04-08 | 87 |
| K061465 | Kinetikos Medical, Inc. | KMI CEMENT RESTRICTOR IMPLANT | 2006-10-05 | 132 |
| K061698 | Life Spine | MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR | 2006-07-12 | 26 |
| K060247 | Life Spine | LIFE SPINE CEMENT RESTRICTOR | 2006-05-11 | 100 |
| K060132 | Spinal USA | SPINAL USA CEMENT RESTRICTOR SYSTEM | 2006-03-16 | 57 |
Recalls for JDK devices
12 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-02-23.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code JDK?
JDK is the FDA product code for prosthesis, hip, cement restrictor. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the Orthopedic panel.
What device class is JDK?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code JDK?
Across 54 cleared submissions the average was 106 days from receipt to decision (median 84).
Which companies have the most JDK clearances?
Osteonics Corp. (6); Spinal Concepts, Inc. (5); Medtronic Sofamor Danek, Inc. (5); Life Spine (2); Spine Next SA (2).
Have JDK devices been recalled?
Yes: 12 product recalls across 3 recall events; the most recent began 2024-02-23.
Next steps
- Run an FDA pathway report with predicate devices for product code JDK
- Run a recall and safety report across every JDK manufacturer
- Watch product code JDK 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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