FDA product code HTT: Burr, Orthopedic
HTT is the FDA product code for burr, orthopedic. 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 HTT, from 4 different applicants. The average 510(k) review took 24 days (median 21). FDA has posted 23 recalls for HTT devices.
Classification
| Field | Value |
|---|---|
| Device name | Burr, Orthopedic |
| 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 HTT clearance
Top HTT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hall Surgical, Division of Zimmer, Inc. | 1 | 1986-07-15 |
| Micro-Aire Surgical Instruments, Inc. | 1 | 1982-07-20 |
| The Anspach Effort, Inc. | 1 | 1980-11-19 |
| Cutter Laboratories, Inc. | 1 | 1976-07-26 |
Most recent HTT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K862529 | Hall Surgical, Division of Zimmer, Inc. | HALL STERILE BUR | 1986-07-15 | 13 |
| K821695 | Micro-Aire Surgical Instruments, Inc. | MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER | 1982-07-20 | 42 |
| K802598 | The Anspach Effort, Inc. | CARBIDE CUTTING INSTRUMENT/INTRAARTICU | 1980-11-19 | 29 |
| K760236 | Cutter Laboratories, Inc. | BUR, SURGICAL CARBIDE | 1976-07-26 | 11 |
Recalls for HTT devices
23 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-05-11.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code HTT?
HTT is the FDA product code for burr, orthopedic. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HTT?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HTT?
Across 4 cleared submissions the average was 24 days from receipt to decision (median 21).
Which companies have the most HTT clearances?
Hall Surgical, Division of Zimmer, Inc. (1); Micro-Aire Surgical Instruments, Inc. (1); The Anspach Effort, Inc. (1); Cutter Laboratories, Inc. (1).
Have HTT devices been recalled?
Yes: 23 product recalls across 6 recall events; the most recent began 2017-05-11.
Next steps
- Run an FDA pathway report with predicate devices for product code HTT
- Run a recall and safety report across every HTT manufacturer
- Watch product code HTT 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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