Engineering Beyond a Single Feature

The Bone Dust Trap combines several design elements, each addressing a different aspect of intraoperative bone collection:
 

• Patented dual-stage filtration designed to support collection of a range of locally generated bone particulate

• 53 cc collection capacity

• Internal architecture designed around particulate and fluid management

• Compact configuration designed to fit within the surgical draping pouch, helping keep the device away from the immediate operating field and reduce unnecessary crowding

• Rigid fixation clip designed for secure positioning

• Integration into the surgical suction pathway

• Practical access to collected autologous bone

• Sterile, single-use configuration
   

No single specification defines the device. The engineering lies in bringing these elements together into one practical collection system.
 

Filtration Is Only Part of the Story

Bone particulate generated during spine surgery is not uniform.

The Rimmedtech™ Bone Dust Trap incorporates a patented dual-stage filtration system designed to support recovery of a range of locally generated bone particulate sizes while incorporating features intended to help reduce clogging during use.

But filtration alone does not define an effective collection system.

How material enters and accumulates within the device, how fluid continues through the suction pathway, how much graft can be accommodated, where the device sits during surgery, and how securely it remains positioned all contribute to its practical function.

That broader engineering approach is central to the Bone Dust Trap design.
 

53 cc Capacity Without Crowding the Operative Field

Collection capacity matters, particularly during procedures where substantial locally generated bone is available.

The Rimmedtech™ Bone Dust Trap provides a 53 cc internal collection volume while maintaining a compact configuration designed to fit within the surgical draping pouch.

This positioning helps keep the device outside the surgeon's immediate working space while allowing it to remain integrated into the suction pathway.

The objective is substantial collection capacity without adding unnecessary equipment around the operative field.
 

Secure Positioning — Designed and Tested

A collection device positioned within surgical draping must remain stable during use.

The Bone Dust Trap incorporates a rigid fixation clip designed to provide secure positioning within the surgical setup.

This feature was evaluated as part of the Rimmedtech™ Bone Dust Trap Mechanical and Functionality Testing program.

As part of Mechanical and Functionality Testing covering multiple device features, the fixation clip was evaluated on 30 finished devices from three separate manufacturing batches. Each clip underwent five displacement cycles, with a minimum required displacement of 12 mm. Across all tested devices:
 

• 30 of 30 clips remained intact and functional

• No cracking

• No permanent deformation affecting function

• No breakage

• No loss of fixation functionality

• Zero test deviations
   

Clip displacement during testing reached up to 26 mm, exceeding the defined minimum displacement requirement.

These results support the mechanical robustness of the fixation feature under the evaluated test conditions.

Mechanical and Functionality Testing White Paper — available upon request.
 

Designed Around the Surgical Environment

Medical device engineering does not stop at filtration performance.

A device must also work within the physical realities of the OR.

The Bone Dust Trap was developed with attention to the entire collection sequence:

Suction → Collection → Filtration → Secure Positioning → Graft Access

Its compact footprint allows positioning within the surgical draping pouch rather than occupying the immediate operative field, while the rigid fixation clip helps maintain secure placement during use.

The goal is straightforward: enable autologous bone collection without unnecessarily complicating the surgical setup.
 

Tested Features, Not Just Design Concepts

Key mechanical and functional characteristics of the Bone Dust Trap have been evaluated through finished-device testing.

This testing forms part of the verification of the device's mechanical and functional design and includes assessment of features such as the fixation system and other device functions under defined test conditions.

For surgeons, hospitals, ASCs, and value-analysis teams seeking more detailed technical information, the Rimmedtech™ Bone Dust Trap Mechanical and Functionality Testing White Paper is available upon request.
 

The Difference Is in the Combination

Individual specifications are easy to list.

Making them function together in the surgical environment is considerably more important.
 

• Patented filtration

• 53 cc collection capacity

• Compact placement inside the draping pouch

• Secure mechanically tested fixation

• Fluid management

• Practical graft access

• Integration into the surgical workflow.
   

Together, these elements form the Rimmedtech™ Bone Dust Trap.

Some of the engineering is visible.
Much of what makes it work is intentionally inside the design.
 

Engineering Extends Beyond the Device Itself

The performance of a medical device depends not only on its design, but also on how consistently that design is translated into the finished sterile product.

For the Rimmedtech™ Bone Dust Trap, engineering therefore extends into material selection, supplier qualification, manufacturing, packaging, sterilization, process validation, inspection, and final product release.

These elements form part of the same overall approach to product quality.

Controlled Manufacturing

The Bone Dust Trap is manufactured through qualified medical-device facilities operating under ISO 13485 quality systems.

Applicable manufacturing and packaging operations are performed within an ISO Class 8 controlled cleanroom environment, helping provide controlled conditions for production and packaging of the finished device.

Manufacturing processes are established, qualified, controlled, and documented within the RIM Medical Technologie QMS in compliance with FDA Quality Management System Regulation (QMSR), 21 CFR Part 820.
 

Validated Packaging and Sterilization

A sterile surgical device depends on more than the device itself.

The sterile barrier system and sterilization process must remain part of the controlled manufacturing process from packaging through final release.

The Rimmedtech™ Bone Dust Trap is produced using validated packaging and terminal sterilization processes, supported by defined qualification, routine controls, and documented product-release requirements.
 

Packaging validation includes evaluation of the sterile barrier and sealing process in accordance with applicable medical-device packaging requirements based on FDA recognizes ISO 11607-1 for sterile-barrier and packaging-system requirements and ISO 11607-2 for validation of forming, sealing, and assembly processes for terminally sterilized medical devices.

This provides another layer of control between the engineered device and the sterile product delivered to the operating room.

Rimmedtech™ Bone Dust Trap Technical and Regulatory Information — available upon request.
 

Materials Selected for Medical Device Use

Material selection begins well before a component reaches final assembly.

USP Class VI materials incorporated into the Rimmedtech™ Bone Dust Trap are selected according to defined design and functional requirements and are supported by supplier qualification, specifications, certificates, and material documentation.

The finished Bone Dust Trap is supported separately through its biocompatibility evaluation and technical documentation.

Sterility and Biocompatibility White Paper — available upon request.
 

Suppliers Selection, Control, Audit

A finished medical device is only as controlled as the materials, components, packaging, and critical services entering its manufacturing process.

For that reason, supplier management is part of the Rimmedtech™ quality approach from the beginning.
 

Critical suppliers are subject to defined controls that include:

Selection → Qualification → Specification Verification → Documentation Review → Performance Monitoring → Audit
 

This includes suppliers associated with device materials, sterile-barrier packaging, manufacturing, and other critical processes.

Supplier qualification is therefore not treated as a purchasing function alone. It forms part of the overall process used to maintain consistency of the finished device.
 

Tested Features, Not Just Design Concepts

Design features are evaluated through defined verification activities before becoming part of the finished-device performance story.

The Rimmedtech™ Bone Dust Trap has undergone Mechanical and Functionality Testing across multiple finished-device features, including the fixation system described above.

Testing is performed against predefined requirements and acceptance criteria using finished production devices.

For hospitals, ASCs, surgeons, and value-analysis teams seeking greater technical detail, supporting testing documentation is available upon request.
 

 Technical Documentation Available Upon Request

Additional documentation for qualified healthcare and value-analysis stakeholders includes:
 

• Rimmedtech™ Bone Dust Trap Technical and Regulatory Information

• Mechanical and Functionality Testing White Paper - detailed information regarding finished-device mechanical and functional verification testing.

• Sterility and Biocompatibility White Paper - supporting information regarding sterilization, material qualification, and biocompatibility evaluation. 
  Additional quality, validation, and technical documentation may be made available as appropriate during hospital or value-analysis review.
   

Important Information

This information is provided for educational purposes and describes selected design, manufacturing, and quality principles associated with the Rimmedtech™ Bone Dust Trap. It does not replace the product Instructions for Use, applicable institutional policies, or professional clinical judgment.

Technical testing statements refer to defined test methods, samples, requirements, and acceptance criteria. Detailed test conditions and supporting documentation are available in the applicable technical records and white papers.