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BRM Tool Screws

FDA 510(k)

Class II (US FDA 510(k))

510(k) K203773

by Brm Extremities Srl

Identifiers

510(k) Number
K203773 FDA 510(k)
FDA Product Code
HWC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BRM Tool Screws are headless interfragmentary lag screws designed for osteosynthesis of small bone fragments. These screws provide self-tapping and self-drilling capabilities, enabling precise fracture reduction and compression for stable internal fixation.

Supplied in multiple diameters and thread lengths, these screws are intended for single-use in orthopedic procedures. They are classified under the FDA’s 510(k) pathway as substantially equivalent to predicate devices, with clearance under K203773. Sterility and regulatory compliance are ensured through manufacturer-controlled processes, adhering to FDA orthopedic device standards.

Frequently asked questions

What types of bone fractures are these screws designed to stabilize, and how do they achieve this?

The BRM Tool Screws are specifically designed for osteosynthesis of small bone fragments, particularly in orthopedic procedures. Their self-tapping and self-drilling features allow for precise placement without requiring pre-drilling, which helps achieve stable internal fixation by compressing fracture fragments together during insertion. This design is ideal for reducing and securing small bone breaks where accuracy and minimal invasiveness are critical.

Are these screws reusable, or are they intended for single-use only? Why does this matter?

The BRM Tool Screws are explicitly intended for single-use only, as stated in the manufacturer’s specifications. This matters because single-use devices reduce the risk of cross-contamination and infection in clinical settings, ensuring patient safety and compliance with sterile procedure protocols. Reusing screws could compromise sterility and structural integrity, potentially leading to complications.

What sizes and configurations are available for these screws, and how might a clinician choose the right one?

The BRM Tool Screws come in multiple diameters and thread lengths, though exact measurements are not specified in the provided data. Clinicians would typically select the appropriate size based on the patient’s anatomy, fracture type, and the specific requirements of the surgical procedure. For example, smaller screws may be used for delicate or fine bone fragments, while longer threads could provide additional stability for larger fragments. Consulting the manufacturer’s sizing guide or surgical planning tools would help ensure proper fit and fixation.

How are these screws sterilized, and what does that mean for storage and handling before use?

The BRM Tool Screws undergo manufacturer-controlled sterilization processes to ensure compliance with FDA orthopedic device standards. While the exact sterilization method isn’t detailed, this implies they are likely gamma-irradiated or ethylene oxide-sterilized, which are common for orthopedic implants. Clinicians should store them in their original, sealed packaging to maintain sterility until use, protecting them from moisture, contamination, or physical damage. Opening the packaging only in a sterile field during surgery is critical to preserving their sterile integrity.

What regulatory pathway was followed for these screws, and what does that mean for their safety and equivalence to other devices?

The BRM Tool Screws were cleared through the FDA’s 510(k) pathway, specifically under clearance number K203773, with a decision labeled as *Substantially Equivalent (SESE)* to predicate devices. This means the FDA determined they have the same intended purpose and technological characteristics as previously approved screws, ensuring they meet established safety and effectiveness standards. The clearance was reviewed by the Orthopedic (OR) Advisory Committee, which evaluates orthopedic devices for structural and functional equivalence to existing products on the market.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BRM TOOL SCREWS - BRM Extremities, Products - BRM Extremities, BRM Extremities | MTEC, BRM TOOL SCREWS - BRM Extremities

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Brm Extremities Srl

Sources (1)

  • FDA 510(k) K203773 24 fields · synced Sep 19, 2026