FDA product code JDZ: Mixer, Cement, For Clinical Use
JDZ is the FDA product code for mixer, cement, for clinical use. It is a Class I device, regulated under 21 CFR 888.4210 and reviewed by the Orthopedic panel. FDA has cleared 13 510(k) submissions under JDZ, from 8 different applicants. The average 510(k) review took 105 days (median 62). FDA has posted 18 recalls for JDZ devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Mixer, Cement, For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 888.4210 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JDZ clearance
Top JDZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stryker Corp. | 3 | 1991-08-29 |
| Howmedica Corp. | 3 | 1985-09-11 |
| Zimmer, Inc. | 2 | 1986-04-14 |
| Exactech, Inc. | 1 | 1994-04-29 |
| Depuy, Inc. | 1 | 1994-01-05 |
3 more applicants have JDZ clearances. See the full list in Caduvo.
Most recent JDZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934253 | Exactech, Inc. | EXACTECH ALL POLY ACETABULAR CUP | 1994-04-29 | 241 |
| K925025 | Depuy, Inc. | PRISM BONE CEMENT MIXING SYSTEM | 1994-01-05 | 460 |
| K912190 | Stryker Corp. | STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST | 1991-08-29 | 104 |
| K892937 | Dentsply Intl. | REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS | 1989-06-22 | 62 |
| K861086 | Zimmer, Inc. | ZIMMER VACUUM MIXING SYSTEM | 1986-04-14 | 24 |
Recalls for JDZ devices
18 product recalls in 9 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-03-30.
| Year | Recalls |
|---|---|
| 2017 | 6 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code JDZ?
JDZ is the FDA product code for mixer, cement, for clinical use. It is a Class I device, regulated under 21 CFR 888.4210 and reviewed by the Orthopedic panel.
What device class is JDZ?
Class I, regulation 21 CFR 888.4210. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JDZ?
Across 13 cleared submissions the average was 105 days from receipt to decision (median 62).
Which companies have the most JDZ clearances?
Stryker Corp. (3); Howmedica Corp. (3); Zimmer, Inc. (2); Exactech, Inc. (1); Depuy, Inc. (1).
Have JDZ devices been recalled?
Yes: 18 product recalls across 9 recall events; the most recent began 2026-03-30.
Next steps
- Run an FDA pathway report with predicate devices for product code JDZ
- Run a recall and safety report across every JDZ manufacturer
- Watch product code JDZ 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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