Written and maintained by CASRAI Editorial Board
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General product and labeling information only, drawn from FDA and NLM records and the Code of Federal Regulations. It is not medical advice and does not describe how any instrument is used on a patient.
Short answer
A Lempert rongeur is a hand-held, reusable, bone-biting surgical instrument. In FDA’s AccessGUDID database, manufacturer listings that use the name carry the FDA product code HTX (“Rongeur”) and the GMDN term “Orthopaedic joint/limb rongeur”, and they are listed as reusable and not sterile on delivery, with sterilization listed as required before use. Lengths and tip widths differ from one listing to the next, so the labeler’s own record and instructions for use settle the details for a specific model.
Definition and scope
“Lempert” is used in these records as a brand and model name; the records do not define the word, so this page does not try to. What the records do define is the device category. The Global Medical Device Nomenclature (GMDN) term 32853, “Orthopaedic joint/limb rongeur”, is defined in three AccessGUDID records as a hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs and joints. The definition adds that it is not primarily intended for nasal, spinal or cranial use and is not a dedicated rib rongeur, and that it is a heavy-duty metallic instrument with a forceps- or pliers-like design. It ends with the sentence “This is a reusable device.”
The regulatory wording is broader. Under 21 CFR 888.4540 an orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery, and the generic type includes the rongeur. It is Class I (general controls) and exempt from premarket notification, subject to the limitations in 21 CFR 888.9. The AccessGUDID record for catalog number 1100-544D also shows the premarket-exempt flag as true.
How it is described in use
The description of function in these records comes from the GMDN definition: the instrument has sprung, self-opening handles that, when squeezed together, close sharp-edged, scoop-shaped jaws to bite through bone. Manufacturer instructions for use, not this page, govern how a given instrument is handled and reprocessed. The one handling fact the records agree on is that the device is reusable and is supplied not sterile, with sterilization listed as required prior to use. For the wider reprocessing context, see CASRAI’s guides on medical device reprocessing and what an autoclave is.
Three Lempert listings compared
The table sets out three AccessGUDID records from one labeler, Sontec Instruments, Inc., that use “Lempert” in the name. It shows how much the same name varies across listings. Fields are quoted as the records give them.
| Field | Catalog 1100-544D | Catalog 315-542Q | Catalog 1100-578Q (Jeurs Lempert) |
|---|---|---|---|
| Description in record | Lempert rongeur curved tip | Classis Lempert rongeur straight jaw Quantum | Curved to side Quantum |
| Listed length | 6.75 in | 6.25 in | 7.5 in |
| Listed tip | 2.5 x 10 mm | 2.5 mm | Tip length 2.5 mm |
| Sterilization methods listed | Dry heat; moist heat or steam | Moist heat or steam; dry heat | Dry heat only |
| Single use | No | No | No |
| Sterile on delivery | No | No | No |
| Sterilize before use | Yes | Yes | Yes |
| MRI safety field | Labeling does not contain MRI Safety Information | Labeling does not contain MRI Safety Information | Labeling does not contain MRI Safety Information |
| FDA product code | HTX, Rongeur | HTX, Rongeur | HTX, Rongeur |
Two points stand out. First, the same name carries different lengths, tip dimensions and jaw shapes (curved tip, straight, curved to side). Second, the sterilization methods listed are not identical: one record lists dry heat only. That is a difference in what each record lists, and each model’s instructions for use remain the authority. Record versions differ in date (the 1100-544D record is dated 2026-03-05, the 315-542Q record 2021-03-15 and the 1100-578Q record 2024-02-28), so a listing can change.
Types and related concepts
Straight, curved and side-curved listings
Shape is named by the labeler. The three records above use “curved tip”, “straight jaw” and “curved to side” in their own descriptions, which is why a shape word in a search or an inventory line is not a standard category.
Lempert and Kerrison
A Kerrison rongeur is a separate instrument; CASRAI’s Kerrison rongeur guide sets out the three-record comparison for that device, including 21 CFR 882.4840 and the HTX and GMDN fields. For limb and joint instruments more broadly, see orthopedic surgical instruments and the neighbouring bone file guide.
Limb and joint versus skull and spine
21 CFR 882.4840 identifies a manual rongeur as a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column, and classifies it as Class II (performance standards). The three Lempert records are coded HTX with a GMDN definition that is limb and joint and “not primarily intended for nasal, spinal, or cranial use”. This page states only what those records show and does not assign a regulatory status to any particular product.
Where it matters for labs, clinics and supply decisions
The records support a short checklist for reading any Lempert listing, whether in a catalog, an inventory sheet or a device database. Every item below corresponds to a field in the AccessGUDID records above.
- GMDN term and definition. Confirms the listing is an orthopaedic joint/limb rongeur (32853), not a skull or spine rongeur.
- FDA product code. HTX “Rongeur” in all three records; a different code is a reason to read that record closely.
- Single use or reusable. All three are listed as not single use.
- Sterile on delivery and sterilize before use. All three are listed as not sterile on delivery, with sterilization required prior to use. Reusable does not mean ready to use.
- Sterilization methods listed. They differ by record, so compare the record and the instructions for use for the exact model.
- Sizes field. Length and tip are the labeler’s entries; do not assume one length or tip width applies to every Lempert.
- MRI safety field. The three records say the labeling does not contain MRI safety information.
- Catalog and version numbers. Match the catalog number, not the name, when identifying an instrument. See the UDI medical device guide and the UDI labeling and GUDID submission guide for how these identifier records are built.
Common misunderstandings
“All rongeurs are the same regulatory class.”
They are not described the same way in the regulations. 21 CFR 888.4540 lists the rongeur among Class I orthopedic manual instruments, while 21 CFR 882.4840 classifies a manual rongeur for skull or spinal surgery as Class II.
“A Lempert has one standard size.”
The three records list lengths of 6.25, 6.75 and 7.5 inches and different tip descriptions.
“Reusable means it arrives sterile.”
The records list the device as not sterile on delivery, with sterilization prior to use.
“Every listing allows the same sterilization methods.”
One record lists dry heat only, and the other two list dry heat plus moist heat or steam. Read the instructions for use for the model in hand.
FAQ
What is a Lempert rongeur?
It is a manual, reusable bone-cutting hand instrument sold under the Lempert name. In the FDA database records it is coded HTX, and the GMDN term describes an orthopaedic joint/limb rongeur.
Is a Lempert rongeur sterile when it arrives?
The three records list it as not sterile on delivery and as requiring sterilization prior to use.
Is a Lempert rongeur single use?
No. All three records list single use as false, and the GMDN definition ends “This is a reusable device.”
How is a Lempert rongeur different from a Kerrison?
They are separate instruments. The Kerrison page covers how a Kerrison record is classified under 21 CFR 882.4840 and 888.4540; this page covers how Lempert listings read.
Sources
- FDA and National Library of Medicine, AccessGUDID: device 00192896048058 (catalog 1100-544D), device 00192896088573 (catalog 315-542Q) and device 00192896116764 (catalog 1100-578Q). Checked 2026-10-30.
- 21 CFR 888.4540, orthopedic manual surgical instrument, eCFR text via Cornell LII. Checked 2026-10-30.
- 21 CFR 882.4840, manual rongeur, eCFR text via Cornell LII. Checked 2026-10-30.
