FDA product code HWE: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
HWE is the FDA product code for instrument, surgical, orthopedic, ac-powered motor and accessory/attachment. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the Orthopedic panel. FDA has cleared 76 510(k) submissions under HWE, from 54 different applicants. The average 510(k) review took 110 days (median 75). FDA has posted 101 recalls for HWE devices.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| Review panel | OR — Orthopedic |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HWE clearance
Top HWE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| U.S. Medical Products, Inc. | 7 | 1996-08-15 |
| Synthes (Usa) | 3 | 2005-01-05 |
| Richard Wolf Medical Instruments Corp. | 3 | 1997-04-07 |
| Stryker Corp. | 3 | 1996-07-26 |
| United American Medical Co., Inc. | 3 | 1994-01-07 |
49 more applicants have HWE clearances. See the full list in Caduvo.
Most recent HWE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K143191 | Mcginley Innovations | IntelliSense Drill | 2015-02-20 | 106 |
| K102743 | Ortho Solutions Limited | ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES | 2011-01-20 | 120 |
| K063688 | The Anspach Effort, Inc. | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE | 2007-01-16 | 35 |
| K050766 | Zimmer Trabecular | EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM | 2005-05-26 | 62 |
| K043310 | Synthes (Usa) | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM | 2005-01-05 | 35 |
Recalls for HWE devices
101 product recalls in 27 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2018-09-19.
| Year | Recalls |
|---|---|
| 2017 | 61 |
| 2018 | 1 |
Frequently asked questions
What is FDA product code HWE?
HWE is the FDA product code for instrument, surgical, orthopedic, ac-powered motor and accessory/attachment. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the Orthopedic panel.
What device class is HWE?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HWE?
Across 76 cleared submissions the average was 110 days from receipt to decision (median 75).
Which companies have the most HWE clearances?
U.S. Medical Products, Inc. (7); Synthes (Usa) (3); Richard Wolf Medical Instruments Corp. (3); Stryker Corp. (3); United American Medical Co., Inc. (3).
Have HWE devices been recalled?
Yes: 101 product recalls across 27 recall events; the most recent began 2018-09-19.
Next steps
- Run an FDA pathway report with predicate devices for product code HWE
- Run a recall and safety report across every HWE manufacturer
- Watch product code HWE 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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