HTW · Bit, Drill
Orthopedic · 21 CFR 888.4540 · Class 1
Overview
| Product Code | HTW |
|---|---|
| Device Name | Bit, Drill |
| Regulation | 21 CFR 888.4540 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
Identification
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Cleared Devices (11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K151661 | Renovo Life Hard Carbon Coated Drill Bit | Renovo Life, LLC | Jan 15, 2016 | SESE |
| K942906 | AGEE-WRISTJACK PRE-DRILL KIT | Hand Biomechanics Lab, Inc. | Dec 22, 1994 | SESE |
| K930339 | REAMER BIT | Neoligaments, Ltd. | Aug 6, 1993 | SESE |
| K915692 | CANNULATED DRILL BIT | W. L. Gore & Associates, Inc. | Jan 16, 1992 | SESE |
| K892903 | MITEK ANCHOR DRILL | Mitek Surgical Products, Inc. | Oct 6, 1989 | SESE |
| K870217 | FEMORAL CEMENT REMOVAL INSTRUMENTS | Kenneth J. Hoek, M.D., Inc. | Feb 6, 1987 | SESE |
| K863147 | GLENOID DRILL | Bowen & Company, Inc. | Sep 5, 1986 | SESE |
| K841629 | DRILL BIT | Plastafil, Inc. | Aug 27, 1984 | SESE |
| K834229 | BONE PLUGGING TOOL | Standard Surgical | Jan 10, 1984 | SESE |
| K831712 | SURGICAL DRILL BITS | Medical Specialists IN Packaging | Jul 7, 1983 | SESE |
| K820226 | UNIVERSALL DRILL GUIDE | Ortho Pared Instruments, Inc. | Feb 4, 1982 | SESE |
Top Applicants
- W. L. Gore & Associates, Inc. — 1 clearance
- Standard Surgical — 1 clearance
- Renovo Life, LLC — 1 clearance
- Plastafil, Inc. — 1 clearance
- Ortho Pared Instruments, Inc. — 1 clearance
