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 how to use a saw on a patient.
Short answer
“Oscillating saw” names two unrelated kinds of tool: a handheld oscillating multi-tool sold for trade and DIY work, and a powered surgical saw used on bone. In the United States, the surgical kind is not regulated as a stand-alone device. Under 21 CFR 878.4820 the saw blade is an accessory of a surgical instrument motor, and the motor and accessories are Class I devices, exempt from premarket notification.
Definition and scope
This page covers the surgical meaning: the powered bone saw, also searched as a sagittal saw. Handheld woodworking and renovation multi-tools share the search term but are not medical devices and are not covered here. Manual (non-powered) bone-cutting instruments are covered in the guide to orthopedic surgical instruments, which treats powered drills and saws as out of scope; this page fills that gap from the regulatory side.
How FDA classifies a powered surgical saw
FDA’s regulation at 21 CFR 878.4820 (checked at the eCFR on 2026-10-30) describes surgical instrument motors and accessories as AC-powered, battery-powered or air-powered devices intended for use during surgical procedures to provide power to operate various accessories that cut hard tissue, bone and soft tissue. The accessories and attachments “may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.” The device is classified Class I (general controls) and is exempt from premarket notification, subject to 21 CFR 878.9.
FDA’s product classification database (checked 2026-10-30) files this regulation under three product codes, one per power source.
| Product code | FDA device name | Power source | Regulation and class |
|---|---|---|---|
| HWE | Instrument, surgical, orthopedic, AC-powered motor and accessory/attachment | AC (mains) | 21 CFR 878.4820, Class 1 |
| KIJ | Instrument, surgical, orthopedic, DC-powered motor and accessory/attachment | DC | 21 CFR 878.4820, Class 1 |
| HSZ | Instrument, surgical, orthopedic, pneumatic powered and accessory/attachment | Pneumatic (air) | 21 CFR 878.4820, Class 1 |
Sources: FDA Product Classification database (codes HWE and HSZ pages) and the openFDA device classification API (code KIJ), all checked 2026-10-30. For HWE the database lists the device as 510(k) exempt and notes that establishments must still register; for HSZ it also states the device is not exempt from the quality-system (GMP) requirements.
Types and related terms
Bone saw and sagittal saw
Both are common names for the powered surgical saw. The regulation does not use the words “sagittal”, “oscillating” or “reciprocating”; it lists a “saw blade” as one accessory of a powered motor. A name used in a catalogue therefore describes the product, not a separate FDA category.
Oscillating saw parts and bone saw parts
The regulation supports a three-part view of a powered saw system: the power source (AC, battery or air), the surgical instrument motor, and the accessory that cuts, the saw blade. Other accessories listed in the same regulation, such as a bur, drill bit, pin driver or dermatome, attach to the same kind of motor, so a listing for a motor or handpiece is not necessarily a listing for a saw.
Related instruments
The osteotome, listed in 878.4820 as a chisel accessory, is also a bone-cutting tool; manual bone instruments such as the bone file are separate products, and the ENT surgical instruments guide covers a neighbouring instrument family.
Where it matters for labs, clinics and supply decisions
A listing check that follows only the regulation text:
- Which component is it? Motor or handpiece, saw blade, or a combined set. The regulation treats the blade as an accessory of the motor.
- What powers it? AC, DC/battery or air-driven. These map to product codes HWE, KIJ and HSZ.
- Which regulation and product code does the manufacturer cite? For this device type the expected answer is 878.4820 and one of the three codes above.
- Does the exemption change registration duties? No. Being exempt from premarket notification does not remove establishment registration; FDA’s database page for HWE says establishments must still register (see FDA registered establishment).
- Powered or manual? Manual instruments are covered by other regulations, so a powered saw should not be filed with them.
Common misunderstandings
- “Class I means no oversight.” Class I devices remain under general controls, and FDA lists registration and quality-system duties for these codes.
- “Sagittal saw and oscillating saw are different regulated devices.” Not in the regulation text; both fall under 878.4820 when powered.
- “Any oscillating saw is a medical device.” A hardware-store multi-tool sold for woodworking is not a surgical instrument motor under this regulation.
FAQ
What is an oscillating saw?
The term covers a handheld oscillating multi-tool for trades and a powered surgical saw for bone. The surgical one is regulated by FDA as a saw blade accessory of a surgical instrument motor.
What is a bone saw?
A bone saw is a powered surgical saw, an accessory cutting hard tissue and bone, run by a surgical instrument motor under 21 CFR 878.4820.
What is a sagittal saw?
It is a common name for a powered bone saw. FDA’s regulation does not define “sagittal”; the device is classified by its motor and saw-blade accessory.
What parts does an oscillating or bone saw have?
Per 878.4820: a power source (AC, battery or air), a surgical instrument motor, and an accessory, here the saw blade.
Sources
- eCFR, 21 CFR 878.4820, Surgical instrument motors and accessories, checked 2026-10-30.
- FDA, Product Classification, code HWE, checked 2026-10-30.
- FDA, Product Classification, code HSZ, checked 2026-10-30.
- FDA, openFDA device classification API, record for product code KIJ, checked 2026-10-30.
