21 CFR 888.4540 — Scissors, Orthopedic, Surgical
Orthopedic (OR) · Part 888 Subpart E—Surgical Devices · § 888.4540
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HRR | Scissors, Orthopedic, Surgical | 1 | 8 | |
| HRT | Stripper, Surgical | 1 | 0 | |
| HTO | Reamer | 1 | 14 | |
| HTP | File | 1 | 5 | |
| HTQ | Broach | 1 | 0 | |
| HTS | Knife, Orthopedic | 1 | 9 | |
| HTT | Burr, Orthopedic | 1 | 4 | |
| HTW | Bit, Drill | 1 | 11 | |
| HTX | Rongeur | 1 | 5 | |
| HWA | Impactor | 1 | 4 | |
| HWB | Extractor | 1 | 5 | |
| HWD | Starter, Bone Screw | 1 | 0 | |
| HWI | Corkscrew | 1 | 1 | |
| HWJ | Awl | 1 | 4 | |
| HWK | Trephine | 1 | 1 | |
| HWL | Set, Hollow Mill | 1 | 0 | |
| HWN | Instrument, Compression | 1 | 4 | |
| HWO | Skid, Bone | 1 | 0 | |
| HWP | Punch, Femoral Neck | 1 | 1 | |
| HWQ | Passer | 1 | 9 | |
| HWR | Driver, Prosthesis | 1 | 4 | |
| HWW | Countersink | 1 | 0 | |
| HWX | Tap, Bone | 1 | 2 | |
| HXB | Probe | 1 | 15 | |
| HXC | Wrench | 1 | 6 | |
| HXE | Fork | 1 | 0 | |
| HXG | Tamp | 1 | 1 | |
| HXI | Passer, Wire, Orthopedic | 1 | 3 | |
| HXJ | Staple Driver | 1 | 6 | |
| HXK | Holder, Needle; Orthopedic | 1 | 5 | |
| HXN | Applier, Cerclage | 1 | 2 | |
| HXO | Pusher, Socket | 1 | 3 | |
| HXP | Instrument, Bending Or Contouring | 1 | 5 | |
| HXQ | Crimper, Pin | 1 | 0 | |
| HXS | Twister, Wire | 1 | 2 | |
| HXW | Bender | 1 | 3 | |
| HXX | Screwdriver | 1 | 4 | |
| HXY | Brace, Drill | 1 | 7 | |
| HXZ | Cutter, Wire | 1 | 1 | |
| KIL | Positioner, Socket | 1 | 1 | |
| LXH | Orthopedic Manual Surgical Instrument | 1 | 58 | |
| LYQ | Accessories, Fixation, Spinal Intervertebral Body | 1 | 3 | |
| LYS | Bone Mill | 1 | 4 | |
| OCJ | Spinal Channeling Instrument, Vertebroplasty | 1 | 1 |
