FDA product code HWR: Driver, Prosthesis
HWR is the FDA product code for driver, prosthesis. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. FDA has cleared 4 510(k) submissions under HWR, from 3 different applicants. The average 510(k) review took 60 days (median 30). FDA has posted 6 recalls for HWR devices.
Classification
| Field | Value |
|---|---|
| Device name | Driver, Prosthesis |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HWR clearance
Top HWR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Warsaw Orthopedic, Inc. | 2 | 1987-03-13 |
| Kim-Med, Inc. | 1 | 1992-06-11 |
| Buckman Co., Inc. | 1 | 1988-01-28 |
Most recent HWR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K915776 | Kim-Med, Inc. | KNEE PROSTHESIS DRIVER | 1992-06-11 | 170 |
| K875054 | Buckman Co., Inc. | ACROMED ADS BONE NAIL DRIVER | 1988-01-28 | 50 |
| K870848 | Warsaw Orthopedic, Inc. | SCHULTZ METACARPAL COMPONENT DRIVER | 1987-03-13 | 10 |
| K870847 | Warsaw Orthopedic, Inc. | SCHULTZ PHALANGEAL COMPONENT DRIVER | 1987-03-13 | 10 |
Recalls for HWR devices
6 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-01-05.
Frequently asked questions
What is FDA product code HWR?
HWR is the FDA product code for driver, prosthesis. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HWR?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HWR?
Across 4 cleared submissions the average was 60 days from receipt to decision (median 30).
Which companies have the most HWR clearances?
Warsaw Orthopedic, Inc. (2); Kim-Med, Inc. (1); Buckman Co., Inc. (1).
Have HWR devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2016-01-05.
Next steps
- Run an FDA pathway report with predicate devices for product code HWR
- Run a recall and safety report across every HWR manufacturer
- Watch product code HWR 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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