HWR · Driver, Prosthesis
Orthopedic · 21 CFR 888.4540 · Class 1
Overview
| Product Code | HWR |
|---|---|
| Device Name | Driver, Prosthesis |
| 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 (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K915776 | KNEE PROSTHESIS DRIVER | Kim-Med, Inc. | Jun 11, 1992 | SESE |
| K875054 | ACROMED ADS BONE NAIL DRIVER | Buckman Co., Inc. | Jan 28, 1988 | SESE |
| K870848 | SCHULTZ METACARPAL COMPONENT DRIVER | Warsaw Orthopedic, Inc. | Mar 13, 1987 | SESE |
| K870847 | SCHULTZ PHALANGEAL COMPONENT DRIVER | Warsaw Orthopedic, Inc. | Mar 13, 1987 | SESE |
Top Applicants
- Warsaw Orthopedic, Inc. — 2 clearances
- Kim-Med, Inc. — 1 clearance
- Buckman Co., Inc. — 1 clearance
