510(k) Clearance

FDA Clearance for Balanced Knee System and BKS TriMax Implants with TSolution One Total Knee Application Active Robot

FDA Clearance for Balanced Knee System and BKS TriMax Implants with TSolution One Total Knee Application Active Robot
THINK Surgical and Ortho Development gained FDA clearance for use of the Balanced Knee System and BKS TriMax Implants with the TSolution One Total Knee Application Active Robot.

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.

Implanet Gains FDA Clearance for JAZZ Cap

Implanet received FDA 510(k) clearance to market JAZZ Cap® to secure screws in poor quality bone in vertebral fusion procedures.

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.

FDA Clears Next SIG Medical AdvantageRib System

SIG Medical received FDA 510(k) clearance for its enhanced AdvantageRib system for rib fracture repair. Full U.S. launch will occur within 1Q19.

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. 

SpineEX Gains FDA Clearance for Sagittae LLIF

SpineEX received FDA 510(k) clearance to market its Sagittae® expandable device for minimally invasive lateral lumbar interbody fusion. 

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.

Synergy Biomedical Launches BIOSPHERE MIS PUTTY

Synergy Biomedical received FDA 510(k) clearance and commenced full launch of BIOSPHERE® MIS PUTTY for open, mini-open and percutaneous minimally invasive procedures.

Field Orthopaedics Gains FDA Clearance for 1.5mm Micro Screw

Field Orthopaedics received FDA 510(k) clearance to market a micro screw system for fixation of fractures, osteotomies and arthrodeses of small bones in the foot, hand and forearm. 

Vallum Gains FDA Clearance of Nanotextured PEEK Interbody

Vallum received FDA 510(k) clearance to market a PEEK interbody fusion device with a PEEKplus® nanotextured surface created with proprietary Accelerated Neutral Atom Beam technology.

FDA 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances

To meet your need to know who's new in the orthopaedic market, I sorted through the 21 companies receiving their first orthopaedic-related FDA 510(k) clearance through May of this year. To keep things simple, I then chose one company from each implantable market segment for a closer look. Here's what I found.

Orthofix Gains FDA and CE Mark Approvals for PhysioStim

Orthofix gained FDA premarket and CE Mark approval for next-gen PhysioStim bone growth stimulators, used as a nonsurgical treatment for nonunion fracture in the extremities.

Globus Medical Unveils FDA-Cleared Trauma Products

Globus Medical debuted its FDA-510(k)-cleared trauma products, comprising fracture plates, compression and cannulated screws, intramedullary nails and external fixation. 

NuVasive Update on COALESCE, COHERE Interbody Fusion Devices

NuVasive launched COALESCE for Thoracolumbar Interbody Fusion, and announced FDA 510(k) clearance to market the COHERE® Cervical Interbody Fusion device with expanded indications.

K2M Receives FDA Clearance for YUKON OCT System

K2M received FDA 510(k) clearance to market the YUKON™ OCT system to support fusion with posterior fixation in the occipito-cervico-thoracic spine.