Osteotomy Bone Spreader No. 2.32 Convex Straight 3.2mm - Hu-Friedy

What is the Osteotome Bone-Spreader #2.32 convex straight 3.2mm - Hu-Friedy - Delynov?

The Osteotome Bone-Spreader #2.32 is a precision surgical instrument designed by Hu-Friedy for bone surgery interventions. This model features a convex tip and a straight shaft, with a diameter of 3.2mm. It belongs to the surgical consumables (CONSO) category and is classified as a Class I medical device. Its structure is specifically designed to meet the requirements of dental surgeons and implantologists during implant site preparation. As a product manufactured by Hu-Friedy Mfg. Co., LLC, it benefits from the expertise of a recognized manufacturer in the field of medical instrumentation, ensuring compliance with rigorous manufacturing standards.

What are the clinical indications for this instrument?

The Osteotome Bone-Spreader #2.32 is primarily indicated in ridge expansion and bone condensation procedures in implantology. Its use occurs when the width of the alveolar ridge is insufficient to accommodate an implant in a conventional manner. The 3.2mm convex shape allows for the progressive widening of the cancellous bone while preserving the integrity of the bone plates. It is also used to compact the bone during implant bed preparation, which can improve the primary stability of the implant in low-density bones. This device is strictly reserved for qualified healthcare professionals practicing oral and implant surgery.

What are the technical characteristics of the Hu-Friedy Bone-Spreader?

Technically, this osteotome features a convex working part with a diameter of 3.2mm, mounted on a straight handle. This straight configuration is ideal for accessing the anterior and premolar maxillary or mandibular sectors. The convex design allows for a uniform distribution of forces during insertion, reducing the risk of unwanted cortical fracture. Manufactured by Hu-Friedy Mfg. Co., LLC, the instrument is designed to withstand the mechanical stresses related to percussion and manual pressure. It is a Class I device, which implies compliance with basic regulatory requirements for non-invasive or reusable surgical instruments according to applicable directives.

What are the contraindications for the use of this osteotome?

Contraindications for the use of the Osteotome Bone-Spreader #2.32 include all clinical situations where bone expansion is deemed risky, such as excessively high bone density (highly mineralized type D1) which could lead to a ridge fracture. It should not be used if the residual bone volume is insufficient to support expansion forces. Additionally, use is contraindicated in patients with serious systemic pathologies affecting bone healing or in case of active infection at the surgical site. The manufacturer Hu-Friedy specifies that the use of this instrument is exclusively reserved for trained healthcare professionals, and any use outside the intended framework is discouraged.

What are the precautions for use and maintenance?

As a reusable surgical instrument, this Hu-Friedy osteotome requires rigorous handling. Before each use, it is imperative to carefully read the instructions provided by the manufacturer. The instrument must be cleaned, disinfected, and sterilized according to current hospital protocols for Class I devices. It is necessary to check the integrity of the 3.2mm convex tip and the absence of corrosion or deformation before any intervention. Particular attention must be paid during percussion to avoid any excessive trauma to the surrounding tissues. Storage must be in a dry and clean environment to preserve the mechanical properties of the instrument over the long term.

Who is the manufacturer and what standards are respected?

The device is manufactured by Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. Hu-Friedy is a globally recognized manufacturer for the quality of its surgical instrumentation. This Bone-Spreader is listed as a Class I medical device. Although the specific CE marking is not detailed in the source data, the product meets US and international regulatory requirements for this category of devices. As a product distributed by Delynov, it is accompanied by the necessary warnings to ensure safe use by healthcare professionals. Compliance with the indications and contraindications mentioned by the manufacturer is essential for patient safety.

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Surgical medical consumables play a decisive role in operative safety.