Device Approvals & Patents
-
Extremities
FDA Clears Anika Therapeutics' X-Twist Knotless Fixation System
X-Twist provides a knotless suture anchor system that can be used for key repairs in the shoulder, foot and ankle, and other extremities.Michael Barbella, Managing Editor 05.20.22
-
Spine/Neurology
NanoHive Medical Expands Patent Portfolio
The patent covers the design of structural lattices with enhanced radiographic visibility.Michael Barbella, Managing Editor 05.18.22
-
Spine/Neurology
FDA OKs Accelus' FlareHawk TiHawk11 Interbodies
The cages have an 11mm-wide insertion profile and expand to 17 x 14mm once inserted.Sam Brusco, Associate Editor 05.12.22
-
FDA Grants Orthofix PMA for its AccelStim Bone Growth Stimulation Device
The AccelStim will be commercially available in the second quarter.Michael Barbella, Managing Editor 05.04.22
-
Spine/Neurology
CTL Amedica Awarded Patent for Expandable Lumbar Interbody Fusion Cage Design
KLIMT Interbody Cages feature a multi-density and variable, textured surface on all sides.Michael Barbella, Managing Editor 04.26.22
-
Extremities | Trauma/Sports
FDA OKs CoNextions' TR Tendon Repair System
Addresses traumatic hand, wrist, and forearm tendon lacerations.Sam Brusco, Associate Editor 04.25.22
-
Extremities
FDA Clears Orthopaedic Implant Company's High-Value Dorsal Spanning Plate
DRPx supports various surgical technique preferences and allows for significant cost savings.Michael Barbella, Managing Editor 04.22.22
-
Large Joint
FDA Approves CartiHeal's Agili-C to Treat Cartilage, Osteochondral Defects
Clinical study showed superiority of Agili-C implant to current surgical standard of care.Sam Brusco, Associate Editor 03.30.22
-
Biologics
OSSIOfiber Implants Gain 3rd FDA Clearance in 4 Months
Company prepares to expand access to bio-integrative orthopedic fixation tech portfolio.Sam Brusco, Associate Editor 03.29.22
-
Spine/Neurology
Life Spine's SImpact SI Joint OK'ed for Posterior-Oblique Approach
Enables physicians to offer the appropriate approach to suit the patient’s anatomy and pathology.Sam Brusco, Associate Editor 03.29.22
-
Instruments | MIS/Robotics
AAOS22: FDA OKs Lazurite's ArthroFree Wireless Camera for MIS
According to the company, it’s the first and only wireless camera system for minimally invasive surgery to earn FDA market clearance.Sam Brusco, Associate Editor 03.25.22
-
Trauma/Sports
FDA OKs Orthofix's TrueLok EVO Ring Fixation System
Company also completed the first U.S. patient cases.Sam Brusco, Associate Editor 03.16.22
-
Extremities
Shoulder Innovations' InSet Stemless Humeral Implant Earns FDA Nod
The humeral component’s design allows minimal bone removal.Sam Brusco 03.14.22
-
Spine/Neurology
VySpine's LumiVy Lumbar IBF System Gains FDA Nod
Designed for use after lumbar discectomy in fusion procedures.Sam Brusco, Associate Editor 03.08.22
-
Spine/Neurology
FDA OKs Cionic's Neural Sleeve
Functional electrical stimulation to assist in gait for those with foot drop and leg muscle weakness.Sam Brusco, Associate Editor 03.08.22
-
Spine/Neurology
CoreLink's Fusation 3D-Printed Cervical Anchor Earns FDA Nod
Supports the company's F3D-C2 cervical stand-alone fusion system.Sam Brusco, Associate Editor 03.08.22
-
VUZE Medical Awarded Three New Patents
Chinese and European patents protect the core workflow of the VUZE System.ODT Staff 03.08.22
-
Imaging | Software & Quality | Trauma/Sports
FDA OKs GLEAMER's BoneView AI Fracture Detection Software
Aids radiologists in fracture detection, reduces reading time.Sam Brusco, Associate Editor 03.02.22
-
Spine/Neurology
Bioventus' Next-Gen StimRouter PNS Earns FDA Nod
Improves on the previous generation via a new smartphone app and new E-ERC.Sam Brusco, Associate Editor 03.02.22
-
Extremities
FDA OKs Gramercy Ortho's New Plating Lines
Distal fibular ankle fracture plating and multi-application extremity plating systems earn FDA clearance.Sam Brusco, Associate Editor 02.22.22
