Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
A Leksell rongeur is a double-action bone-biting forceps, listed by manufacturers in several lengths, jaw widths and curves. This page shows what the FDA’s own device records say about those listings and how the product is classified.
What a Leksell rongeur is
FDA defines a manual rongeur as “a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column” (21 CFR 882.4840(a), checked 2026-10-30). “Leksell” is a pattern name used in manufacturers’ product descriptions; the regulation does not define it. In FDA’s GUDID device database, listings describe Leksell rongeurs as double-action, with a spring handle in at least one record, and with jaws that are curved, angled or cup-shaped.
Who uses it: by the regulation’s wording, surgical teams working on bone of the skull or spine. Some listing names add “Neuro/Spine” or “Laminectomy” (for example STERIS V. Mueller and Hayden Medical records). Instrument-processing staff and buyers also handle these listings.
Types and variants seen in FDA’s device listings
The table lists variants as worded in GUDID device descriptions (openFDA UDI endpoint, checked 2026-10-30; 265 records matched “leksell” and “rongeur”). Company names identify the record, not a recommendation.
| Variant (as listed) | Listing wording | Example record |
|---|---|---|
| Full or strongly curved, double action | “double-action, strongly curved jaws, 5.0mm bite, spring handle” | Ambler Surgical |
| Duckbill | “Leksell Duckbill Rongeur 9-1/4″, Curved, 3mm Bite” | Integra Miltex |
| Bayonet, right-angled jaw | “LEKSELL BAYONET RONGEUR RIGHT ANGLED JAW” | Sontec Instruments |
| Angled, cup-shaped jaws (Dawson-Yuhl-Leksell) | “ANGULAR CUP-SHAPED JAWS 2X13MM … 11-1/2 inches” | STERIS V. Mueller |
| Straight (Leksell-Stille) | “LEKSELL-STILLE Bone Rongeur, straight, 9 1/2″ (240 mm), double action” | Aesculap |
| Single-use | “Leksell Rongeur, 250mm, 8mm Bite” (record flagged single-use) | Eakin Surgical |
Sizes listed in GUDID
| Overall length | Jaw or bite width | Curve | Record |
|---|---|---|---|
| 9 in (230 mm) | 3 mm x 13 mm | Curved 50 degrees | Med Saver |
| 9-1/4 in | 5 mm | Full curved | Integra Jarit |
| 9-1/4 in | 8 mm | Full curved | Integra Ruggles-Redmond |
| 9 in (23.0 cm) | 6.0 mm and 8.0 mm (two records) | Fully curved | Novo Surgical (flagged single-use) |
| 9-1/2 in (24.1 cm) | 3 mm and 4 mm (two records) | Standard and full curve | Hayden Medical |
| 9-3/4 in (24.8 cm) | 8 mm x 16 mm | Regular curve | STERIS Affinity |
| 11-1/2 in (29.2 cm) | 2 mm x 13 mm | Angular, cup-shaped | STERIS V. Mueller |
| 36 cm | 5 mm | Light curve | Surgix Medical |
Lengths in these records run from 9 inches to 36 cm, and jaw widths from 2 mm to 8 mm. Listings state sizes in different units and orders, so read length, bite and curve separately.
How FDA classifies a Leksell rongeur
Two FDA product codes are involved. HAE, “Rongeur, Manual”, is Class II under 21 CFR 882.4840 (neurology). HTX, “Rongeur”, is Class I under 21 CFR 888.4540, the orthopedic manual surgical instrument regulation (openFDA classification database, checked 2026-10-30). 21 CFR 888.4540(b) places that device in Class I (general controls) and exempts it from premarket notification, subject to the limitations in 21 CFR 888.9.
In the 265 GUDID records matching Leksell rongeur, 202 carry HTX and 34 carry HAE; other codes appear less often (LXH 12, HBG 6, EMH 5). A name alone therefore does not tell you the class: check the product code in the record. This is an observation of how manufacturers listed these devices, not a legal conclusion about any one product.
Common mistakes when reading listings
- Treating “Leksell” as a single size. The records above span lengths from 9 inches to 36 cm and bites from 2 mm to 8 mm.
- Assuming the name sets the regulatory class. The same pattern name appears under Class I and Class II product codes.
- Assuming reusable. Some records are flagged single-use in GUDID; others are not.
- Mixing up related patterns. Kerrison and Lempert rongeurs are separate instruments; see our Kerrison rongeur and Lempert rongeur guides, and the general bone rongeur guide.
Related instruments
For the wider instrument families, see neurosurgical instruments and orthopedic surgical instruments. Buyers browsing the category can find forceps on lac.us.
FAQ
What is a Leksell rongeur used for?
FDA describes manual rongeurs as instruments for cutting or biting bone during surgery involving the skull or spinal column (21 CFR 882.4840(a)).
Is a Leksell rongeur a Class I or Class II device?
It depends on the product code in the listing: HAE is Class II (21 CFR 882.4840) and HTX is Class I (21 CFR 888.4540). Most GUDID Leksell listings carry HTX.
What sizes are listed?
Records show overall lengths from 9 inches to 36 cm and jaw or bite widths from 2 mm to 8 mm; see the table above.
Sources
- 21 CFR 882.4840 Manual rongeur, https://www.law.cornell.edu/cfr/text/21/882.4840, checked 2026-10-30.
- 21 CFR 888.4540 Orthopedic manual surgical instrument, https://www.law.cornell.edu/cfr/text/21/888.4540, checked 2026-10-30.
- openFDA device classification, https://api.fda.gov/device/classification.json?search=product_code:HTX, checked 2026-10-30.
- openFDA UDI (GUDID) records, https://api.fda.gov/device/udi.json?search=device_description:leksell+AND+device_description:rongeur, checked 2026-10-30.
