FDA 510(k) Recap: Globus Medical Intros Total Knee Technology
A review of four enabling technology clearances from DePuy Synthes, Globus Medical, Providence Medical and VUZE....
Jul 23 2024,
Products
eCential Robotics Gains 510(k) Clearance for Spine Navigation and Robotic Assistance
This device provides support to plan and instrument spinal fusion procedures....
Jul 22 2024,
Smith+Nephew Gains 510(k) for CATALYSTEM Primary Hip
CATALYSTEM, compatible with CORI robotics, addresses the increased adoption of anterior approach procedures and the expanding role of Ambulatory Surgery...
Jul 16 2024,
FDA 510(k) Recap: Solutions Focused on Spine
Small companies look for market coverage with new spinal hardware, fracture-detecting technology and navigation software....
Jun 25 2024,
Breakthrough Device Designation for Infuse Bone Graft
This designation addresses Infuse in a TLIF approach in the treatment of degenerative disease of the lumbosacral spine....
May 30 2024,
Shoulder Innovations Unveils Humeral Pre-op Planning Feature with ProVoyance Shoulder
This new feature will support precise planning of all available InSet humeral stems, including the newly released InSet 95 Stem....
May 28 2024,
FDA 510(k) Recap: Clearances in Joint Replacement, Spine and Trauma
This month’s recap offers joint replacement implants, a spinal implant augmentation device and a hip fracture nail....
May 28 2024,
Exactech Debuts Next Generation GPS Hardware Technology
First total knee surgeries leverage the next generation of ExactechGPS hardware, with enhanced system responsiveness, connectivity and fast proprietary active...
May 28 2024,
First Cases with Tetrous EnFix TAC Demineralized Bone Fiber Implants
The EnFix product line is specifically designed to address Enthesis Failure Syndrome in rotator cuff repair....
May 08 2024,
First Surgery with Zimmer Biomet ROSA Shoulder System
ROSA Shoulder is designed to give surgeons the flexibility to execute a total shoulder case using anatomic or reverse techniques...
Apr 25 2024,
FDA 510(k) Recap: Clearances in Orthobiologics and Spine
This month’s recap offers spinal fusion products from Curiteva and Providence Medical Technology, followed by bone grafts from SurGenTec and...
Apr 24 2024,
SAIL Fusion Gains FDA 510(k) for BowTie Sacroiliac Fusion
BowTie is reported to be the only SI fusion device to incorporate intra-articular and transfixing components. ...
Apr 23 2024,
Treatment of First Patients with HYALEX Knee Cartilage System
Hyalex Orthopaedics is running the prospective, multi-center, single-arm studies in the U.S. and Europe, with sites for both studies having...
Apr 22 2024,
RELJA Innovations Launches RELJA Clamp and RELJA Foot Plating
RELJA Clamp is a first-of-its kind radiolucent, single-use bunion reduction clamp and is applied in less than four minutes....
Apr 19 2024,
FDA 510(k) Recap: First Clearances for Small Companies in Sports Med
These companies recently received their first orthopedic-related clearances for products in the sports medicine segment....
Mar 27 2024,