Rimmedtech™ Bone Dust Trap FAQ - Frequently Asked Questions
Rimmedtech™ Bone Dust Trap FAQ Frequently Asked Questions
What is the Rimmedtech™ Bone Dust Trap?
The Rimmedtech™ Bone Dust Trap is a sterile, disposable intraoperative bone graft recovery system designed to support the collection of locally generated autologous bone particulate during orthopedic and spine surgical procedures. The device is intended to integrate into established surgical workflows without requiring changes to routine surgical technique.
What type of bone graft does the device collect?
The device is designed to collect locally generated autologous bone particulate created during routine bone preparation, drilling, burr use, osteotomy, or decompression procedures.
Is the Bone Dust Trap intended to replace other graft materials?
No.
The Bone Dust Trap is designed to support collection of locally generated autologous bone. Surgeons determine how collected autograft is used within their preferred grafting strategy, whether alone or in combination with other graft materials when clinically appropriate.
Which surgical specialties may use the Bone Dust Trap?
The device is designed for orthopedic and spine surgical procedures where locally generated bone particulate may be available for collection.
Examples include:
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Spine surgery
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Orthopedic procedures
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Selected revision procedures
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Other bone procedures at the surgeon's discretion
Does the device require changes to existing surgical workflow?
No.
The Bone Dust Trap was developed specifically to integrate into established surgical workflows. It connects within the suction system and is intended to support efficient collection of bone particulate without introducing additional procedural complexity.
Is special training required?
The Bone Dust Trap is intended for use by qualified healthcare professionals. Product orientation and educational support are available from RIM Medical Technologies, and in most cases a single product demonstration or in-service presentation is sufficient to familiarize users with the device.
Is the device sterile?
Yes.
The Bone Dust Trap is supplied sterile and is intended for single-patient use.
Can the device be reprocessed or resterilized?
No.
The device is intended for single-patient use only and should not be reused or resterilized.
What makes the filtration system different?
The Rimmedtech™ Bone Dust Trap incorporates a unique patented dual-stage filtration system designed to support the recovery of a broad range of locally generated bone particulate while incorporating features intended to help reduce filter clogging during use. Combined with a 53 cc collection chamber, the design is intended to support efficient, continuous bone graft collection throughout the procedure, helping maximize the amount of locally generated autologous bone available for surgeon evaluation and use.
How much material can the device collect?
The collection chamber has an internal volume of approximately 53 cc. Actual collected volume depends on the procedure, surgical technique, and available locally generated bone.
Has the device been tested?
Yes.
The Bone Dust Trap has undergone biocompatibility, packaging, sterilization, mechanical, functional, and performance testing in accordance with applicable FDA recognized standards as part of product development and quality system requirements. Manufacturing, packaging, and sterilization are validated and performed in ISO 13485-certified facilities.
Is the Bone Dust Trap patented?
Yes.
The technology is protected by patents in multiple jurisdictions, including Canada, the United States, the European Union, the United Kingdom, Japan, and China.
Is the company FDA registered?
RIM Medical Technologies maintains U.S. FDA establishment registration and operates under a Quality Management System aligned with applicable FDA Quality Management System Regulation (QMSR) requirements.
Where is the device manufactured?
The Bone Dust Trap is manufactured, packaged, and sterilized through validated ISO 13485-certified manufacturing partners operating under RIM Medical Technologies' Quality Management System.
Where can I find scientific literature?
Please contact us to request White Papers and scientific literature reviews. The Knowledge Centre includes educational resources discussing:
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Autologous bone graft
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Bone grafting strategies
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Workflow considerations
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Clinical literature
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Educational articles
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Product resources
How can I request a product evaluation or demonstration?
Healthcare professionals, hospitals, ambulatory surgery centers, and distributors may contact RIM Medical Technologies through the Contact page to request additional product information or discuss evaluation opportunities.
Information provided in this FAQ is intended for educational purposes and does not replace the Instructions for Use (IFU) or professional clinical judgment. Device use should always be consistent with the product labeling and applicable institutional policies.