Device Approvals & Patents
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Extremities
FDA Clears Orthopaedic Implant Company's Wrist Fracture Plate
Designed with Type II anodized titanium, the DRPx plate features variable angle and fixed angle locking screws, locking pegs, and non-locking screws.Accesswire 08.05.21
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Spine/Neurology
FDA OKs Aurora Spine's DEXA-C Cervical Interbodies
Custom-made implants based on matching patient's bone density.GlobeNewswire 08.04.21
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Spine/Neurology
CE Mark, FDA Breakthrough Device Designation Granted for DDD Tech
Spinal Stabilization Technologies' PerQdisc device replaces the nucleus pulposus of the intervertebral disc in the L1 - S1 spinal region.PR Newswire 08.03.21
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Spine/Neurology
FDA 510(k) Clearance Granted for NuVasive's Pulse Platform
First-of-its-kind platform integrates multiple technologies to address most common clinical challenges in spine surgery.NuVasive Inc. 07.30.21
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Spine/Neurology
NeuroMetrix's Quell Earns Breakthrough Status for Fibromyalgia
There's an unmet need for safe and effective non-pharmacological fibromyalgia treatments.GlobeNewswire 07.21.21
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Spine/Neurology
FDA OKs Nevro's Senza SCS for Painful Diabetic Neuropathy
10 kHz stimulation cleared for chronic pain associated with PDN.PR Newswire 07.19.21
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Extremities | Trauma/Sports
Stryker's InSpace Rotator Cuff Repair Implant Earns FDA Nod
Breakthrough solution for arthroscopic treatment of massive irreparable rotator cuff tears.PR Newswire 07.13.21
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CE Mark Granted to NuVasive's Pulse Platform
Clinical evaluations of the technology are underway within multiple European countries.PR Newswire 06.30.21
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Spine/Neurology
Integrity's Expandable Lumbar Interbody Fusion Device Wins CE Mark
FlareHawk has also received approvals in Argentina, New Zealand, Taiwan, the United Arab Emirates, and the United States.Integrity Implants 06.28.21
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Bone Health Technologies Receives Patent for OsteoBoost Vibration Belt
Patent grant follows recent closing of a $2.5 million funding round and the appointment of three board members.Bone Health Technologies 06.11.21
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Large Joint | Spine/Neurology
FDA OKs CyMedica's IntelliHab Knee Pain Management
Neuromodulation strengthening therapy and patient engagement system for knee osteoarthritis pain relief.PR Newswire 06.09.21
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Hensler Surgical Granted CE Certification for Bone Press
Device has been used for nine years in select countries.PR Newswire 06.09.21
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Trauma/Sports
FDA OKs Biorez's BioBrace Implant
Biocomposite soft tissue scaffold is designed to reinforce tendon and ligament repairs.Sam Brusco, Associate Editor 06.02.21
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Spine/Neurology
FDA OKs ChoiceSpine's Blackhawk Ti Cervical Spacer
Builds on the already successful original Blackhawk PEEK device with integrated anchor technology.Sam Brusco, Associate Editor 05.26.21
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Spine/Neurology
FDA Breakthrough Designation Awarded to Lumbar Nucleus Replacement System
Spinal Stabilization Technologies' product also earns CE Mark.Michael Barbella, Managing Editor 05.26.21
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Spine/Neurology
Life Spine Issued 200th Patent
Company's IP portfolio consists of more than 265 patents and applications.Michael Barbella, Managing Editor 05.24.21
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FDA Clears Orthofix's OrthoNext Digital Platform for the JuniOrtho Plating System
The Plating System is designed to address the demands of advanced deformity and trauma reconstruction of the lower extremities.Michael Barbella, Managing Editor 05.10.21
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Instruments | Large Joint
FDA Clears MY01's Continuous Compartment Pressure Monitor
Aids in diagnosis of Compartment Syndrome, an orthopedic emergency.Sam Brusco, Associate Editor 05.06.21
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Extremities | Imaging
FDA OKs GSI's PreView 3D Shoulder Arthroplasty Planning Software
Develops pre-operative shoulder plans based on CT imaging studies.Sam Brusco, Associate Editor 05.06.21
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Spine/Neurology
FDA Clears Life Spine's PROLIFT Lateral HELO Fixation System
The expandable lateral spacer restores disc height.Michael Barbella, Managing Editor 05.05.21
