Indications for Use
The KLS Martin SonicWeld Rx (Resorb-X) is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations. In addition, resorbable meshes, plates, screws and pins may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.
The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation. The KLS Martin SonicWeld RX (Resorb-X) is not intended for areas with active or latent infection or for patient conditions including limited blood supply or insufficient quantity or quality of bone.
These devices are not intended for use in the spine.
The SonicWeld Rx pins are designed only to be inserted with the SonicWeld Rx Sonotrode device.
FDA 510K 080862
The SonicWeld Rx Suture Anchor - Endobrow Fixation is intended for use to support non-load bearing tissues of the craniofacial skeleton, including but not limited to endobrow fixation.
FDA 510K 061507
System
SonicWeld Rx pins are fully compatible with KLS-Martin's Resorb-X range of plates, meshes, and foils. The product is sterile packed. SonicPins are loaded on to the handpiece from simple to...
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Clinical Results
Biological, mechanical and histological testing and clinical validation have proven the biocompatibility of SonicWeld Rx implants. It maintains its strength for approximately 10 weeks...
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