Regulatory

Episurf Medical Patent and Regulatory Updates

Episurf Medical Patent and Regulatory Updates
Episurf Medical received an additional patent in China relative to the Episealer® Femoral Twin joint implant design process and expects to obtain CE Mark Approval for the Episealer Talus ankle implant.

DeGen Medical Gains New FDA Clearances

DeGen Medical received FDA clearance to market the F1 MPS Modular Pedicle Screw System for JOUST Minimally Invasive Surgery and the Cyclops Anterior Cervical Plate.

FDA 510(k) Recap: Spinal Devices and Technologies from 1H19

With the NASS 2019 Annual Meeting approaching, it's an ideal time to revisit spine products that have gained FDA 510(k) clearance in the first half of the year. This round-up shares another entrant into the sacroiliac joint treatment arena, an implant company's first clearance for an enabling technology and additional details about some lesser-known companies to watch.

FDA 510(k) Recap: Spinal Devices and Technologies from 1H19

With the NASS 2019 Annual Meeting approaching, it's an ideal time to revisit spine products that have gained FDA 510(k) clearance in the first half of the year. This round-up shares another entrant into the sacroiliac joint treatment arena, an implant company's first clearance for an enabling technology and additional details about some lesser-known companies to watch.

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.

Brainlab Recalls Spine & Trauma 3D Navigation Software

Brainlab Recalls Spine & Trauma 3D Navigation Software
Brainlab recalled Spine & Trauma 3D Navigation 1.0 software due to the potential for incorrect information to display during surgery, preventing acccurate navigation of surgical tools inside the patient. FDA has identified this as a Class I recall.

Alphatec Gains FDA Clearance for SafeOp Neuromonitoring

Alphatec received FDA 510(k) clearance to market automated SafeOp neuromonitoring for use in real-time intra-op nerve location and health assessment. Commercial launch will occur within 1H19.

OSSIO Gains FDA Clearance for OSSIOfiber Bone Pin

OSSIO received FDA 510(k) clearance to market OSSIOfiber bone pins, made of a bio-integrative material designed to provide stability and secure bone fixation that will leave no hardware behind. 

Simplify Medical Completes Cervical Disc IDE Trial

Simplify Medical completed enrollment and treatment of all patients in its U.S. Investigational Device Exemption pivotal trial evaluating the Simplify® Disc for two-level cervical disc replacement.

SI-BONE Announces UK Guidance Recommendation for iFuse

The U.K.'s National Institute for Health and Care Excellence published medical technology guidance recommending SI-BONE's iFuse® for the treatment of chronic sacroiliac joint pain.

FDA Approves Update of Mobi-C Cervical Disc Labeling to Include 7-Year Clinical Results

FDA approved an update to the labeling for Zimmer Biomet's Mobi-C® Cervical Disc to include 7-year clinical results, showing the device to be statistically non-inferior in overall study success for 1-level use and statistically superior in overall study success for 2-level use.

NICE Recommendation for TranS1 AxiaLIF in the UK

TranS1 announced NICE recommendation for approval of the AxiaLIF® system and presacral approach among standard arrangments to treat severe chronic low back pain.