Written and maintained by CASRAI Editorial Board
Last updated
General product and classification information only; this is not medical advice and does not describe surgical technique.
Short answer
A bone curette is a hand-held, non-powered surgical instrument with a long handle and a sharp-edged, concave, spoon-like tip, designed for cutting and excising bone tissue. In FDA records the same physical instrument can carry different product codes and regulation numbers, depending on how the manufacturer labels it. All the codes below are Class 1.
Definition and scope
The Global Medical Device Nomenclature (GMDN) term “Bone curette, reusable” (code 31335), as shown in the FDA AccessGUDID record for one KLS-Martin instrument, defines it as a manual surgical instrument for cutting and excising bone tissue, typically in orthopaedic or plastic surgery. It is typically a long, slender instrument with a handle at one end and a concave, spoon-like tip with a sharp edge at the other, or it may be double-ended. The same definition describes it as typically made of stainless steel and reusable.
That is a different tool from the curettes used on skin, teeth or adenoid tissue. For those, see the CASRAI guides on the dermal curette, dental curette and adenoid curette. For the broader family of curette designs, see surgical curette.
What the record says about use and reprocessing
The GMDN definition above describes the instrument as designed to cut and excise bone tissue. Technique and instrument selection are decisions for the operating surgeon and the manufacturer’s instructions for use, and are outside this page.
For reprocessing, the AccessGUDID record lists the device as not sterile when supplied, with sterilization required before use by moist heat or steam. It is recorded as not single-use. A given manufacturer’s instructions for use govern the actual reprocessing method for its own product.
Types and related instruments
Angled curette
“Angled” is a descriptive word that appears in product titles and refers to the shaft or tip geometry the manufacturer names. It is not a separate FDA category: an angled bone curette is classified by the same product codes as other curettes, and this page makes no claim about which geometry suits which task.
Related bone instruments
A curette removes tissue with a scooping, sharp-edged tip. Other bone instruments are separate tools with their own pages: the osteotome (a chisel-type instrument) and the bone file. The orthopedic surgical instruments overview shows how the wider set is organised.
Where it matters for labs, clinics and supply decisions
Original comparison: how one instrument type appears under different FDA classifications. Checked against openFDA classification data on 2026-10-31 (api.fda.gov/device/classification).
| FDA product code | Name in FDA data | Regulation | Class | Specialty panel |
|---|---|---|---|---|
| FZS | Curette, Surgical, General Use | 21 CFR 878.4800 | 1 | General, Plastic Surgery |
| HTF | Curette | 21 CFR 878.4800 | 1 | General, Plastic Surgery |
| LXH | Orthopedic Manual Surgical Instrument | 21 CFR 888.4540 | 1 | Orthopedic |
| HAO | Instrument, Surgical, Non-Powered | 21 CFR 882.4535 | 1 | Neurology |
The KLS-Martin bone curette record (model 23-395-02-07, description “BONE, MOLT, NO. 2”) carries product code FZS, so it falls under the general-use manual surgical instrument regulation. 21 CFR 878.4800 describes such devices as nonpowered, hand-held or hand-manipulated, reusable or disposable, for general surgical procedures, and names the curette in its list; the regulation classifies them as Class I and exempt from premarket notification, subject to the limitations in 878.9. 21 CFR 882.4535 covers nonpowered neurosurgical hand instruments, also naming curettes, as Class I and exempt subject to the limitations in 882.9.
Checklist for reading a bone curette product record
- GMDN term: does it say “bone curette” and whether it is reusable or single-use?
- Product code and regulation number: FZS and HTF point to 878.4800; LXH to 888.4540; HAO to 882.4535. A different code does not by itself mean a different physical design.
- Class and exemption: all four codes above are Class 1; confirm the limitations referenced in the relevant regulation.
- Sterility and reprocessing: is it supplied sterile or not sterile, and which sterilization method does the record list?
- Title wording: terms such as “angled” or a pattern name describe the product line; read the manufacturer’s own description for what they mean.
Common misunderstandings
- “Curette” means one instrument. It is a family: the dermal, dental, adenoid and bone versions are different devices.
- A different FDA code means a different design. The same sort of hand instrument is listed under general-surgery, orthopedic and neurology codes.
- Class I means no rules. Class I devices are subject to general controls; exemption from premarket notification is limited by the regulation’s own limitations section.
FAQ
What is a bone curette?
A manual surgical instrument with a sharp-edged, concave, spoon-like tip, designed for cutting and excising bone tissue (GMDN term 31335, via AccessGUDID).
What is an angled curette?
A curette whose product title describes an angled shaft or tip. It is a geometry description in the manufacturer’s title, not a separate FDA category, and it does not rank one shape against another.
How does FDA classify a bone curette?
In FDA data, a bone curette appears as Class 1 under product codes FZS, HTF, LXH and HAO, which map to 21 CFR 878.4800, 888.4540 and 882.4535.
Sources
- openFDA device classification API, product codes FZS, HTF, LXH, HAO (checked 2026-10-31): api.fda.gov device classification query; documentation at open.fda.gov/apis/device/classification
- FDA AccessGUDID record for KLS-Martin curette, DI 00888118028983 (checked 2026-10-31): accessgudid.nlm.nih.gov/devices/00888118028983
- 21 CFR 878.4800, Manual surgical instrument for general use (checked 2026-10-31): eCFR
- 21 CFR 882.4535, Nonpowered neurosurgical instrument (checked 2026-10-31): eCFR
