JANSEN Single-Joint Bone Rongeur

Overview

The JANSEN Single-Joint Bone Rongeur is a precision surgical instrument engineered for controlled bone and calcified tissue removal in preclinical research and veterinary orthopedic procedures. Designed in accordance with ISO 7153-1:2016 (Surgical instruments — Metallic materials — Part 1: Stainless steel) and compliant with EN ISO 13485:2016 quality management requirements for medical device manufacturers, this rongeur features a single-axis pivot mechanism that delivers consistent mechanical advantage and tactile feedback during bone trimming, laminectomy, or osteophyte excision. Its ergonomic handle geometry minimizes hand fatigue during prolonged use, while the hardened stainless-steel jaws (AISI 420 or equivalent) ensure long-term edge retention and resistance to corrosion under repeated sterilization cycles (autoclave up to 134 °C, 3 bar).

Key Features

• Single-joint articulation design optimized for high-torque transmission and precise tip control—ideal for confined anatomical spaces such as spinal canals or cranial base approaches.
• Two clinically validated configurations: S21006-17 (straight jaw, 3.5 mm jaw width, 17.5 cm total length) and S21007-17 (angled-small jaw, 3.5 mm jaw width, 17.5 cm total length, 25° distal bend).
• Electropolished surface finish (Ra ≤ 0.4 µm) to reduce bioburden adhesion and enhance cleanability per ISO 15883 standards for washer-disinfectors.
• Non-slip, textured polymer-coated handles (medical-grade thermoplastic elastomer) providing secure grip under wet or gloved conditions.
• Compatible with standard instrument tracking systems via laser-etched alphanumeric serial number on the shank (permanent marking per ISO 15223-1).

Sample Compatibility & Compliance

This rongeur is intended for ex vivo and in vivo use in animal models (murine, porcine, canine, and non-human primate) where bone morphology, density, and cortical thickness align with typical rodent lumbar vertebrae or murine calvarial thickness (0.1–0.8 mm). It is not indicated for human clinical use without additional regulatory clearance (e.g., FDA 510(k), CE Class I or IIa, or NMPA registration). All units are manufactured under an ISO 13485-certified quality system and undergo 100% functional testing—including jaw alignment verification, spring tension calibration, and tip closure gap measurement (< 0.05 mm)—prior to packaging. Sterilization validation includes biological indicator (Geobacillus stearothermophilus) challenge testing per ANSI/AAMI ST46:2019.

Software & Data Management

As a manually operated, non-electronic surgical instrument, the JANSEN Single-Joint Bone Rongeur does not incorporate embedded electronics, firmware, or data logging capabilities. However, it supports full traceability within laboratory information management systems (LIMS) and electronic lab notebooks (ELN) through its unique serialized identifier. Institutions conducting GLP-compliant studies may document usage logs—including procedure date, operator ID, animal ID, and sterilization cycle number—in accordance with OECD Principles of Good Laboratory Practice (GLP) Section 5.2 (Equipment Maintenance and Calibration Records). No software installation, license key, or cybersecurity protocol is required.

Applications

• Preclinical spinal surgery: partial laminectomy, facet joint resection, and pedicle preparation in rat or rabbit models of spinal fusion.
• Orthopedic implantation studies: contouring of cortical bone beds prior to titanium screw or hydroxyapatite scaffold placement.
• Neurosurgical modeling: calvarial window creation and skull base bone thinning in transcranial optogenetics or intracranial pressure monitoring protocols.
• Veterinary teaching labs: hands-on training in fundamental bone manipulation techniques under faculty supervision.
• Tissue engineering: harvesting of viable periosteal flaps with minimal thermal or mechanical trauma due to cold-cutting mechanical action.

FAQ

Is this instrument certified for human clinical use?
No. The JANSEN Single-Joint Bone Rongeur is manufactured and labeled exclusively for research use in animal models and veterinary applications. Human use requires separate regulatory authorization.
What sterilization methods are validated for this instrument?
Autoclaving at 134 °C for 5 minutes (pre-vacuum cycle) is fully validated. Ethylene oxide (EtO) and low-temperature hydrogen peroxide plasma sterilization are also compatible, though cycle parameters must be verified per facility SOPs.
Can the jaws be resharpened after extended use?
Yes—professional sharpening services using diamond-lapped fixtures calibrated to original OEM specifications are recommended every 20–30 sterilization cycles to maintain optimal cutting performance and minimize tissue drag.
Does RWD provide instrument tracking documentation for audit readiness?
Yes. Each unit ships with a Certificate of Conformance (CoC) listing material lot numbers, inspection records, and sterilization validation summaries—fully aligned with FDA 21 CFR Part 11 electronic record integrity expectations for regulated preclinical studies.