FDA 510(k) Recap: Catch Up on the Latest Clearances
This month’s collection includes improved kinematic knee alignment and a 3D-printed sacroiliac fixation system....
Jan 22 2024,
Products
Stryker Expands the Gamma4 Hip Fracture Nailing System
Expansions to the Gamma4 Hip Fracture Nailing System include an intermediate nail, RC Lag Screw and an anti-rotation clip with...
Jan 17 2024,
3Spine MOTUS FDA Clinical Trial Enrollment Update
3Spine's MOTUS device replaces the function of the disc and facet joints through a posterior approach....
Jan 10 2024,
Paragon 28 Launches Grappler Knotless Anchor and Bridgeline Tape
Grappler and Bridgeline are complementary to a range of Paragon 28’s existing hardware products, with several applications spanning multiple...
Jan 05 2024,
Spinal Simplicity Granted 510(K) for Liberty-SI Lateral Implant
The Liberty-SI Lateral Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac disruptions and degenerative sacroiliitis....
Dec 12 2023,
ZimVie Announces Compatibility Between Vital Spinal Fixation and Brainlab Spine & Trauma Navigation
ZimVie received FDA clearance for its Vital Spinal Fixation System, including instruments for use with Brainlab Spine & Trauma Navigation....
Dec 12 2023,
NSite Medical Gains 510(k) for AI Scoliosis Scanning Tool
NSite Medical's app uses algorithms to analyze spinal curvature with high precision, facilitating early diagnosis and more effective treatment strategies....
Dec 12 2023,
FDA Clearance for ExactechGPS Ankle Surgical Navigation
GPS Ankle connects the preoperative plan with real-time intraoperative instrument guidance and confirms that resections meet the surgical plan....
Dec 05 2023,
Monogram Orthopaedics Delivers First Surgical Robot
Monogram Orthopaedics has delivered its first surgical robot to one of the world's largest global robotics distributors....
Nov 28 2023,
FDA 510(k) Recap: New Entries in Trauma and Sports Medicine
DePuy Synthes, long a player in the trauma and sports medicine segments, is joined by four startups that are building...
Nov 28 2023,
FDA 510(k) for Corin Apollo Robotic-Assisted Total Knee Arthroplasty
Corin was granted FDA 510(k) clearance to market the Apollo Robotic-Assisted Surgical platform and the ApolloKnee software application....
Nov 17 2023,
Paragon 28 Introduces JAWS Great White Staple
The staple features an ultra-low-profile bridge with increased surface area to enhance stability while minimizing soft tissue irritation....
Nov 17 2023,
Orthofix Launches the WaveForm L Interbody
The 3D-printed WaveForm L features a porous structure that prioritizes strength and stability to provide a robust fusion environment....
Nov 17 2023,
Treatment Milestone with ZimVie Vertebral Body Tethering System
Over 50 surgeons have performed VBT using the Tether system to treat over 2,000 patients diagnosed with adolescent idiopathic scoliosis....
Oct 31 2023,
FDA Clearance for Xēnix Medical SOLACE Sacroiliac Fixation
SOLACE is reported to be the only nanotechnology sacroiliac fixation system designed specifically for a lateral, oblique or posterior sacral...
Oct 31 2023,