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Regulatory Report: 42 Companies that Received their First Orthopedic-Related FDA 510(k) in 2018

Small companies around the world continue to seek access to the expansive U.S. market. In 2018, 42 companies received their first ever orthopedic-related FDA 510(k) or first FDA 510(k) in a new market segment. The companies and products we mention here are excerpted from chapters of the upcoming 2019 installment of THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT.

Apr 23, 2019

SI-BONE Gains FDA Clearance of iFuse Bedrock Fixation Technology

Spine

SI-BONE received an additional FDA 510(k) clearance for use of iFuse Bedrock technology in fusion of the sacroiliac joint during long construct procedures.

Apr 15, 2019

Life Spine Launches SIMPACT SI Joint Fixation Study

Spine

Life Spine initiated an outcomes study for SIMPACT® Sacroiliac Joint Fixation.

Feb 14, 2019

Blue Cross Blue Shield of Arizona Covers SI BONE iFuse Implant System

Spine

SI-BONE's iFuse Implant System received exclusive coverage from Blue Cross Blue Shield of Arizona.

Dec 07, 2018

SI-BONE reports 3Q18 revenue of $13.4MM, +14.5% vs. 3Q17

Company Revenue

SI-BONE reports 3Q18 revenue of US $13.4MM, +14.5% vs. 3Q17.

Dec 03, 2018

Aurora Spine Reports 3Q18 Revenue of $2.7MM, +59.6% vs. 3Q17

Company Revenue

Aurora Spine reports 3Q18 revenue of US $2.7MM, +59.6% vs. 3Q17.

Nov 27, 2018

HealthPartners Covers RTI’s SImmetry SI Joint Fusion

Spine

HealthPartners, the largest consumer-governed nonprofit healthcare organization in the U.S., issued a positive coverage decision for minimally invasive sacroiliac joint fusion surgery, expanding patient access to RTI Surgical's SImmetry System.

Nov 19, 2018

Aurora Spine Gains Access to SI Fusion Patent

Mergers & Acquisitions

Aurora Spine acquired an exclusive license to a U.S. patent pertinent to sacroiliac joint repair.

Nov 16, 2018

RTI Surgical Acquiring Paradigm Spine

Mergers & Acquisitions

RTI Surgical entered into a definitive agreement to acquire Paradigm Spine in a cash and stock transaction valued at up to US $300MM.

Nov 02, 2018

SI-BONE Closes Initial Public Offering

Investments

SI-BONE closed its previously-announced initial public offering of 8,280,000 shares of common stock, priced at US $15 per share. The company is now trading on Nasdaq with the ticker symbol SIBN.

Oct 22, 2018

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