HTS · Knife, Orthopedic
Orthopedic · 21 CFR 888.4540 · Class 1
Overview
| Product Code | HTS |
|---|---|
| Device Name | Knife, Orthopedic |
| 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 (9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K930507 | CUSTOM ORTHOPAEDIC TRAYS (PACKS) | Associated Medical Products Co. | Feb 22, 1994 | SESE |
| K933921 | ACUFLEX DISPOSABLE KNIVES | Acufex Microsurgical, Inc. | Jan 26, 1994 | SESE |
| K882525 | SPINAL MICROKNIFE | Karlin Technology, Inc. | Sep 22, 1988 | SESE |
| K873714 | BANANA KNIFE, DISPOSABLE #TM-1612 | Arthropedics, Inc. | Nov 2, 1987 | SESE |
| K873713 | TRIANGULAR KNIFE, DISPOSABLE #TM-1611 | Arthropedics, Inc. | Nov 2, 1987 | SESE |
| K873711 | RETROGRADE KNIFE, DISPOSABLE #TM-1613 | Arthropedics, Inc. | Nov 2, 1987 | SESE |
| K873712 | STANDARD KNIFE, DISPOSABLE #TM-1610 | Arthropedics, Inc. | Oct 15, 1987 | SESE |
| K842820 | ARTHROSCOPY KNIVES | Medtech Industries, Inc. | Aug 14, 1984 | SESE |
| K771851 | ARTHROSCOPE OPERATIVE KNIFE SET | Richard Wolf Medical Instruments Corp. | Oct 27, 1977 | SESE |
Top Applicants
- Arthropedics, Inc. — 4 clearances
- Richard Wolf Medical Instruments Corp. — 1 clearance
- Medtech Industries, Inc. — 1 clearance
- Karlin Technology, Inc. — 1 clearance
- Associated Medical Products Co. — 1 clearance
