Written and maintained by CASRAI Editorial Board
Last updated
Not medical advice. This page gives general product and regulatory information about a surgical hand instrument. It does not describe how to perform any procedure.
Short answer
An osteotome is a nonpowered, hand-held surgical instrument used on bone. FDA lists “osteotome” by name in 21 CFR 878.4800 (manual surgical instruments for general use), where the device is Class I and exempt from 510(k) premarket notification, subject to the limits in 21 CFR 878.9. In FDA’s device database it carries product code HWM.
Definition and scope
The regulation that names it describes the group as “a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures.” The osteotome appears in a long list of instruments in that section, next to pliers, rasp, retractor, saw and scalpel blade. The same list names the chisel, the mallet and the gouge as separate entries, so FDA treats a chisel and an osteotome as two named instrument types, not as one term.
Two near-identical words cause most of the confusion. An osteotome is the instrument. An osteotomy is a surgical cut or opening made in bone, which is a procedure or the site it creates. The Implant Practice article below uses the second word for the prepared bone site in dental implant work.
How it is used in practice
A trade article in Implant Practice US (read 2026-10-30; the author’s own account of clinical practice, not a regulator’s statement) describes an osteotome as a tapered or straight-walled instrument with a handle that can be manipulated by hand or tapped with a surgical mallet. The same article says it comes in two main tip varieties, convex and concave, in straight and offset configurations, and that sets are usually supplied as matched series that start at a small diameter and increase in steps. These are one clinician’s descriptions in a dental setting; an osteotome is also listed for general and neurosurgical use (see below).
Types and related concepts: which FDA regulation applies
The same word appears in more than one part of the Code of Federal Regulations, and not every bone-related instrument section names it. The table lists only what each section’s text says (eCFR text read 2026-10-30).
| Regulation | Device group | Names “osteotome”? | Class |
|---|---|---|---|
| 21 CFR 878.4800 | Manual surgical instrument for general use | Yes | Class I, exempt from 510(k) subject to 878.9 |
| 21 CFR 882.4535 | Nonpowered neurosurgical instrument | Yes, as “specialized chisels, osteotomes, curettes…” | Class I, exempt from 510(k) subject to 882.9 |
| 21 CFR 888.4540 | Orthopedic manual surgical instrument | No (lists awl, broach, impactor, rongeur, tamp and others) | Class I, exempt from 510(k) subject to 888.9 |
| 21 CFR 872.4120 | Bone cutting instrument and accessories (dental/oral surgery) | No (lists bone drill, wire driver, rotary handpiece, saw) | Class II |
Section 878.4800 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 is why a neurosurgical osteotome is covered by 882.4535 while the general-use osteotome sits under 878.4800. For instruments in neighbouring specialties, see the CASRAI guides on neurosurgical instruments, dental surgical instruments and orthopedic surgical instruments.
Where it matters for labs, clinics and supply decisions
For anyone reading a catalogue record or a vendor listing, three public fields identify what the record is claiming. The check below uses FDA’s and NLM’s own data.
- Product code and name. openFDA’s classification database (last updated 2026-10-19) lists product code HWM, device name “Osteotome”, medical specialty “General, Plastic Surgery”, device class 1, regulation number 878.4800.
- Premarket status. An AccessGUDID record (device identifier 00888118117168, read 2026-10-30) shows brand name “OSTEOTOME”, description “STEINBACHER, GUARDED, 4 MM TIP”, and “Device Exempt from Premarket Submission: Yes”, with single use recorded as “No”. It is cited only as an example of what a listed record contains, not as a recommendation.
- Reusable versus disposable. Section 878.4800 covers instruments “either reusable or disposable”, so the single-use field in the record, not the instrument name, tells you which one a listing describes.
A matching HWM code and a Class I, 510(k)-exempt status describe regulatory placement only. They say nothing about size, tip shape or fitness for a given procedure; those details come from the manufacturer’s labeling. Related reading: the CASRAI guide to the bone file, another manual bone instrument classified under the same general-use section.
Common misunderstandings
Is an osteotome the same as a chisel?
Not in the regulation. Section 878.4800 lists “chisel” and “osteotome” as separate names. The Implant Practice article describes the osteotome as a hand instrument with a tapered or straight-walled shaft that may be tapped with a mallet; a catalogue may use the two words differently, so read the device description.
Is osteotome a dental term?
No. Dental implant literature uses it often, but the general-use regulation and the neurosurgical regulation both name it, and the dental bone-cutting regulation (872.4120) does not.
Does Class I mean no oversight?
No. Class I devices are subject to general controls. The 510(k) exemption in 878.4800 is itself “subject to the limitations in 878.9”.
FAQ
What is an osteotome?
A nonpowered, hand-held surgical instrument named in 21 CFR 878.4800 and in 21 CFR 882.4535, used on bone. This page does not cover how it is used in any procedure.
How does FDA classify an osteotome?
As Class I (general controls), exempt from 510(k) subject to 21 CFR 878.9, under product code HWM and regulation 878.4800 (openFDA, 2026-10-30).
What is the difference between an osteotome and an osteotomy?
The osteotome is the instrument; an osteotomy is a surgical cut or opening in bone, or the prepared site in implant dentistry.
Are osteotomes single-use?
The regulation covers reusable and disposable instruments. Single use is recorded per product in the GUDID record, for example “No” for the listed example above.
Sources
- eCFR, 21 CFR 878.4800, Manual surgical instrument for general use: ecfr.gov (read 2026-10-30).
- eCFR, 21 CFR 882.4535, Nonpowered neurosurgical instrument: https://www.ecfr.gov/current/title-21/section-882.4535 (checked 2026-10-30).
- eCFR, 21 CFR 888.4540, Orthopedic manual surgical instrument: https://www.ecfr.gov/current/title-21/section-888.4540 (checked 2026-10-30).
- eCFR, 21 CFR 872.4120, Bone cutting instrument and accessories: https://www.ecfr.gov/current/title-21/section-872.4120 (checked 2026-10-30).
- openFDA device classification, product code HWM: api.fda.gov (data last updated 2026-10-19; read 2026-10-30).
- NLM AccessGUDID record: accessgudid.nlm.nih.gov (read 2026-10-30).
- Implant Practice US, “Time to go old school: time to grab that osteotome”: implantpracticeus.com (trade article, read 2026-10-30).
