Strategic orthopaedic-related 510(k)s issued in May 2017 include: Locking Plate System (Beijing KeYi Medical Device), Collagen Meniscus Implant XL (Ivy Sports Medicine), Kirschner Wires (Precifit Medical), SICAGE System (Sicage), MALUC Total Hip Arthroplasty System (SurgTech)
TRICARE, a managed healthcare program for active duty and retired members of the U.S. military, established a written coverage policy for minimally invasive SI joint fusion such as is provided with SI-BONE’s iFuse™ implant.
Six-year study results on the treatment of SI joint disorders indicated that treatment with conservative management or radiofrequency denervation led to worsened outcomes, while iFuse Implant patients demonstrated superior improvements.
Zyga Technology enrolled the 100th patient in the EVoluSIon trial investigating long-term results and pain reduction following the SImmetry® Sacroiliac Joint Fusion procedure.
Results from a study of Zyga Technology’s SImmetry® Sacroiliac Joint Fusion indicate radiographically-evident fusion as early as 12 months, and increased fusion rates at 24 months.
The U.K.’s National Institute for Health and Care Excellence published guidance recommending availability of minimally invasive sacroiliac joint fusion surgery to treat chronic sacroiliac pain.
Retrospective study results on patients undergoing sacroiliac joint fusion vs. fixation showed a 5.7% revision rate in fusion patients receiving SI-BONE’s iFuse™ vs. a 30.8% revision rate for those undergoing screw fixation.