Written and maintained by CASRAI Editorial Board
Last updated
General product and regulatory information only; this page is not medical advice and does not describe surgical technique.
Short answer
A bone file is a hand-held, nonpowered file used as a surgical instrument. In US federal regulation, the word “file” is named in two device classifications: orthopedic manual surgical instruments (21 CFR 888.4540) and manual surgical instruments for general use (21 CFR 878.4800). Both are Class I and exempt from 510(k) premarket notification, subject to stated limits. “Rasp” appears only in the general-use list.
Definition and scope
The term “bone file” is a trade and catalogue name, not a defined regulatory term. The regulations name a “file” inside broader device types, so the classification of any given product depends on its labelled intended use.
- Orthopedic manual surgical instrument (21 CFR 888.4540). The regulation defines this as “a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.” Its generic type includes the file, together with items such as the awl, broach, burr, reamer, rongeur, bone tap and trephine.
- Manual surgical instrument for general use (21 CFR 878.4800). This is “a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures.” Its list includes the file and the rasp, alongside the chisel, curette, elevator, gouge, osteotome and saw.
The general-use regulation adds that “a surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.” That sentence is why the same word can appear in a general list and in an orthopedic list.
How the classification works in practice
Both regulations assign Class I (general controls) and exempt the device from the premarket notification procedures in subpart E of part 807, subject to a limitations section (21 CFR 888.9 for the orthopedic type; 21 CFR 878.9 for the general-use type).
The orthopedic limitations text states that the exemption applies “only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type.” A manufacturer must still submit a premarket notification when the device is intended for a use different from that of a legally marketed device of that type, or when it operates using a different fundamental scientific technology. The regulation’s own example of the second case is a surgical instrument that cuts tissue with a laser beam rather than with a sharpened metal blade. For background on the notification pathway itself, see the FDA 510(k) premarket notification guide.
Both definitions are limited to nonpowered hand-held devices. A powered file, burr or saw is therefore not described by either text as written.
Which regulation names which term
| Term | Named in 21 CFR 888.4540 (orthopedic) | Named in 21 CFR 878.4800 (general use) |
|---|---|---|
| File | Yes | Yes |
| Rasp | No | Yes |
| Rongeur | Yes | No |
| Curette | No | Yes |
| Elevator | No | Yes |
| Osteotome | No | Yes |
| Reamer | Yes | No |
Source: the identification paragraph (a) of each regulation, checked in the eCFR on 2026-10-30. A term being absent from a list is a statement about that list only, not about whether a product of that name exists or how it is cleared.
Related instruments
CASRAI covers neighbouring instruments in separate guides: the orthopedic surgical instruments overview explains how orthopedic and general-use classifications differ, the Kerrison rongeur guide covers one named rongeur, the Freer elevator guide covers an elevator, and the surgical retractor guide covers a third general-use instrument. By the regulation lists above, rongeur and reamer sit in the orthopedic text, while curette, elevator and osteotome sit in the general-use text.
Where it matters for labs, clinics and supply decisions
A short checklist, each point taken from the regulatory text above, for reading a product listing or label:
- Intended use. Both exemptions depend on the device matching the characteristics and intended use of the legally marketed generic type (21 CFR 888.9 and 878.9). The labelled intended use is the starting point for which regulation applies.
- Nonpowered and hand-held. Both definitions are written for nonpowered hand-held devices. A powered tool is outside the wording.
- Reusable or disposable. The general-use definition explicitly covers either “reusable or disposable” devices; the orthopedic definition does not state either way.
- Specialty versus general. If a product is labelled for a specific specialty, 21 CFR 878.4800 says it is classified in the separate regulations for that specialty (parts 868 through 892), so the general-use entry may not be the one that applies.
Common misunderstandings
- “File” and “rasp” are the same thing. The regulations list them as separate terms, and only the general-use list names the rasp.
- Class I means no FDA requirements. Class I devices remain subject to general controls. The 510(k) exemption is conditional and is lost if the intended use or fundamental technology differs from the legally marketed type.
- “Orthopedic” on a label settles the classification. The regulation text ties classification to the device’s characteristics and intended use, not to a catalogue heading.
FAQ
What is a bone file?
It is a nonpowered, hand-held file instrument. In the CFR, “file” is named in the orthopedic manual surgical instrument classification and in the general-use manual surgical instrument classification.
Is a bone file a Class I device?
Under both 21 CFR 888.4540 and 21 CFR 878.4800 the generic type is Class I (general controls), exempt from 510(k) subject to the limitations in 888.9 and 878.9 respectively.
Is a bone file the same as a bone rasp?
The two regulations list them separately. “Rasp” is named in 21 CFR 878.4800 and not in 21 CFR 888.4540.
Are powered bone files covered by these classifications?
The definitions in both regulations describe nonpowered hand-held devices, so a powered instrument is not described by this wording.
Sources
- 21 CFR 888.4540, Orthopedic manual surgical instrument, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-888/subpart-E/section-888.4540, checked 2026-10-30.
- 21 CFR 878.4800, Manual surgical instrument for general use, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-878/subpart-E/section-878.4800, checked 2026-10-30.
- 21 CFR 888.9, Limitations of exemptions from section 510(k), https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-888/section-888.9, checked 2026-10-30.
- 21 CFR 878.9, Limitations of exemptions from section 510(k), https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-878/section-878.9, checked 2026-10-30.
