[ NEWS - LEGAL & REGULATORY AND REIMBURSEMENT ]
510 ( k ) Clearance for a ‘ BowTie ’ SI Joint Fixation Device
This is a truly novel SI Joint fixation design .
And the U . S . Food and Drug Administration ( FDA ) has granted 510 ( k ) clearance to its “ BowTie ” designed sacroiliac fusion system .
According to the FDA 510 ( k ) summary document , the novel sacroiliac joint ( SI ) fusion system is “ intended to provide stabilization of the sacroiliac joint until fusion occurs .” It includes an implant and a set of ancillary instruments . The implant is comprised of an “ interarticular component , an iliac screw , and a transfix screw .”
Again , referring to the FDA summary document , the BowTie is indicated for “ sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis .” When the system is implanted , “ both the iliac and transfix screw components must be used .”
It looks like a BowTie and it is brand named , BowTie™ SI Joint Fusion System . SAIL Fusion , LLC submitted the 510 ( k ) application . According to the company , BowTie™ “ is the first SI fusion technology to be based on long-standing , validated joint fusion principles established by the AO Foundation and is now the sole commercially available device that incorporates both intra‐articular and transfixing components .”
SAIL Fusion President and CEO David Jansen explained to OTW , “ The BowTie device , with its trademark bowtie shape , was designed to help achieve the AO ’ s other significant joint fusion principle of rigidly fixating the joint to provide a biologic environment favorable for bone growth . We reinforced its rigidity by adding both integrated iliac and transfixation screws to address the complex biomechanics of the pelvis .”
Jansen continued , “ We are pleased that BowTie ’ s multiplanar approach to fixating the joint also closely aligns with both the Transfixation and the recently established Intra-Articular CPT codes . This is an exciting time for surgeons , and especially for patients struggling with chronic SI joint pain .”
The primary predicate device for BowTie ’ s clearance was the SILO TFX MIS Sacroiliac Joint Fixation System by Aurora Spine , Inc . According to the 510 ( k ) summary document , the device is substantially equivalent to the primary predicate device “ in all facets including function , design , performance , material , and intended use .” — KD
BowTie SI Joint Fusion System
Source : SAIL Fusion , LLC
FDA Clears Award Winning Lumbar Facet Device
The U . S . Food and Drug Administration ( FDA ) has granted 510 ( k ) clearance to a lumbar facet device which was a 2023 Best Technology in Spine award winner . The manufacturer is SC Medica , and the device brand name is SC Medica FFX ® .
The novel facet fixation system is for use in lumbar spinal fusion surgery . According to the FDA ’ s 510 ( k ) summary document , the device is “ placed bilaterally through a posterior surgical approach and spans the facet interspace .” It must be used with “ an FDA-cleared transfacet screw cleared for use in the lumbar spine .”
The device is intended to “ provide temporary fixation and stabilization to the spine as an aid to lumbar fusion through bilateral immobilization of the facet joints at one or two levels with autogenous and / or allogenic bone graft .”
It must be accompanied by “ an FDA-cleared intervertebral body fusion device and / or with an FDAcleared posterior lumbar pedicle screw and rod system implanted at the same spinal level ( s ) as an adjunct to a single or two-level intervertebral body or posterolateral fusion , respectively .”
The device is indicated for the “ treatment of patients with lumbar degenerative disc disease ( DDD ) from L3 to S1 in skeletally mature patients who have failed conservative care .”
A device must be substantially equivalent to a predicate device to qualify for shorter and earlier 510 ( k )
24 - RYORTHO . COM
FFX ®
Source : SC Medica