Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
Orthopedic surgical instruments (also spelled orthopaedic surgical instruments, and searched as surgical orthopedic instruments or surgical instruments orthopedic) are, in US regulatory terms, nonpowered hand-held devices used to manipulate tissue or to work with other devices in orthopedic surgery. The US FDA gives them their own classification, separate from general surgical hand instruments, and that boundary is the most useful way to sort the catalogue.
Who uses them: orthopedic surgeons and operating-room teams use the instruments; sterile processing staff, clinic and surgery-center buyers, and students meet them as catalogue items, instrument sets and exam topics. For the specialty itself, see what orthopedics is.
What orthopedic surgical instruments are
Under 21 CFR 888.4540, 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.” Two words in that definition do the sorting. Nonpowered means a hand-driven tool; a powered drill or saw is not this category. Hand-held means the surgeon’s hand supplies the force and control.
The regulation is a generic-type definition: a product belongs to the category by what it is and where it is used, not by a brand or a set name.
Instrument types named in the FDA regulation
The regulation lists the generic types it covers. Grouped by name for easier scanning, they include:
- Wire and pin handling: cerclage applier, wire cutter, wire twister, pin crimper, passer
- Boring and shaping: awl, drill brace, burr, countersink, trephine, reamer, broach, file, bone tap, femoral neck punch
- Driving and seating: impactor, tamp, prosthesis driver, socket pusher, socket positioner, staple driver, bone screw starter
- Turning and gripping: screwdriver, wrench, needle holder, extractor, corkscrew, fork, bone skid
- Cutting, probing and shaping: rongeur, scissors, probe, surgical stripper, bender, bending or contouring instrument, compression instrument
The full list in 888.4540(a) reads: 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. The groupings above are editorial shorthand for reading that list; the regulation itself does not group them.
Orthopedic versus general manual surgical instruments
A second regulation, 21 CFR 878.4800, covers manual surgical instruments for general use: “a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures.” It adds that a surgical instrument with specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. Orthopedics is one of those specialties, which is why its hand instruments sit in 888.4540.
| Feature | Orthopedic manual surgical instrument (21 CFR 888.4540) | Manual surgical instrument for general use (21 CFR 878.4800) |
|---|---|---|
| Defined as | Nonpowered hand-held device for manipulating tissue or use with other devices in orthopedic surgery | Nonpowered, hand-held or hand manipulated device, reusable or disposable, for various general surgical procedures |
| Examples named in the regulation | Awl, broach, reamer, rongeur, screwdriver, wrench, bone tap, trephine | Clamp, forceps, hemostat, retractor, scalpel blade, curette, osteotome, mallet |
| FDA class | Class I (general controls) | Class I (general controls) |
| Premarket notification (510(k)) | Exempt, subject to the limitations in 21 CFR 888.9 | Exempt, subject to the limitations in 21 CFR 878.9 |
Both regulations name a “file”, and 878.4800 also names the osteotome, mallet, rasp and saw, which people often associate with bone work. The practical point is that a catalogue labelled “orthopedic” can contain items regulated under either section, so the label alone does not tell you the regulatory category. The regulation text does.
For individual general-purpose instrument families, see the CASRAI guides on surgical retractors, hemostats and types of surgical scissors.
What the classification does and does not tell you
Class I means general controls are the applicable level of regulatory control. Exempt from premarket notification means a manufacturer does not have to submit a 510(k) for this generic type, within the limits set out in 888.9. Neither statement describes quality, material or suitability for a given use, and the regulation does not set sizes, materials or reprocessing requirements. Those come from the manufacturer’s instructions for use.
Powered instruments and implants
This page covers manual instruments only. Powered drills and saws, and implants such as screws, plates and prostheses, fall under different regulations and different requirements, and are not described here.
Safe use and handling basics
Handling, cleaning and sterilization for any instrument are set by the manufacturer’s instructions for use for that specific product, including whether it is reusable or single-use. Follow those instructions and your facility’s reprocessing policy rather than assuming one routine fits every instrument in a set.
Common mistakes
- Treating “orthopedic” as a regulatory category by itself. Check whether an item is the generic type named in 888.4540 or in 878.4800.
- Assuming Class I and 510(k)-exempt means unregulated. General controls still apply, and the exemption carries limitations in 888.9 and 878.9.
- Mixing manual and powered tools. The orthopedic manual category is defined as nonpowered.
- Assuming “orthopaedic” and “orthopedic” are different products. They are two spellings of the same term.
FAQ
What are orthopedic surgical instruments?
Under FDA’s 21 CFR 888.4540, they are nonpowered hand-held devices used to manipulate tissue, or alongside other devices, in orthopedic surgery. The regulation names types such as the awl, broach, reamer, rongeur, screwdriver and wrench.
Are orthopaedic and orthopedic surgical instruments the same thing?
Yes. Orthopaedic is the British spelling; the products and the US regulatory definition are the same.
How does FDA classify orthopedic manual surgical instruments?
Class I (general controls), exempt from premarket notification, subject to the limitations in 21 CFR 888.9.
How are they different from general surgical instruments?
General manual instruments (clamps, forceps, retractors, scalpel blades) fall under 21 CFR 878.4800, which sends instruments with specialized uses in a specific specialty to separate regulations. Orthopedic hand instruments are covered by 888.4540.
Sources
- eCFR, 21 CFR 888.4540, Orthopedic manual surgical instrument, checked 2026-10-29.
- eCFR, 21 CFR 878.4800, Manual surgical instrument for general use, checked 2026-10-29.
