FDA product code HWT: Template
HWT is the FDA product code for template. It is a Class I device, regulated under 21 CFR 888.4800 and reviewed by the Orthopedic panel. FDA has cleared 10 510(k) submissions under HWT, from 9 different applicants. The average 510(k) review took 104 days (median 27). FDA has posted 85 recalls for HWT devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Template |
| Device class | Class I |
| Regulation | 21 CFR 888.4800 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HWT clearance
Top HWT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Depuy, Inc. | 2 | 1977-10-06 |
| Ortho-Graphics, Inc. | 1 | 1998-02-18 |
| Integrated Surgical Systems, Inc. | 1 | 1997-01-17 |
| Kronner Medical | 1 | 1990-07-23 |
| Warsaw Orthopedic, Inc. | 1 | 1987-05-27 |
4 more applicants have HWT clearances. See the full list in Caduvo.
Most recent HWT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974406 | Ortho-Graphics, Inc. | ORTHOPLAN | 1998-02-18 | 89 |
| K960685 | Integrated Surgical Systems, Inc. | ORTHODOC PREOPERATIVE PLANNER MODEL 500 | 1997-01-17 | 332 |
| K894228 | Kronner Medical | KRONNER SPHERICAL CUTTERS | 1990-07-23 | 399 |
| K870843 | Warsaw Orthopedic, Inc. | SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA | 1987-05-27 | 85 |
| K871323 | Orthopedic Systems, Inc. | ARTHROSCOPIC MENISCAL SUTURE SYSTEM | 1987-05-01 | 28 |
Recalls for HWT devices
85 product recalls in 23 recall events; 3 initiated in the last five years and 2 still open. Most recent: 2024-06-27.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2022 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code HWT?
HWT is the FDA product code for template. It is a Class I device, regulated under 21 CFR 888.4800 and reviewed by the Orthopedic panel.
What device class is HWT?
Class I, regulation 21 CFR 888.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HWT?
Across 10 cleared submissions the average was 104 days from receipt to decision (median 27).
Which companies have the most HWT clearances?
Depuy, Inc. (2); Ortho-Graphics, Inc. (1); Integrated Surgical Systems, Inc. (1); Kronner Medical (1); Warsaw Orthopedic, Inc. (1).
Have HWT devices been recalled?
Yes: 85 product recalls across 23 recall events; the most recent began 2024-06-27.
Next steps
- Run an FDA pathway report with predicate devices for product code HWT
- Run a recall and safety report across every HWT manufacturer
- Watch product code HWT 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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