Device Approvals & Patents
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Spine/Neurology
Integrity Implants Granted CE Mark for Expandable Lumbar Interbody Fusion Device
The FlareHawk system is now approved in Europe, the United States, Argentina, New Zealand, Taiwan, and the United Arab Emirates.Globe Newswire 10.22.21
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Imaging | Large Joint | Software & Quality
FDA OKs Naviswiss' Naviplan Hip Replacement Pre-op Planning Software
Enables orthopedic surgeons to perform navigated CT-based total hip replacement surgery.PR Newswire 10.21.21
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Spine/Neurology
FDA OKs Life Spine's ProLift Micro Expandable Spacer System
Supports micro-invasive procedures ranging from endoscopic TLIFs to MIS TLIFs/PLIFs.Business Wire 10.12.21
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Spine/Neurology
Amber Implants VCFix Spinal System Earns FDA Breakthrough Nod
VCFix treats vertebral fractures without relying on bone cement.PR Newswire 10.12.21
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Spine/Neurology
SyncThink Earns Second FDA Nod for EYE-SYNC Platform
Novel algorithm leverages AI to identify concussion without need for a baseline test.SyncThink 10.07.21
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3-D Printing/Additive Mfg. | Spine/Neurology
FDA OKs ChoiceSpine's Triton SI Joint System
3D-printed screw intended for sacroiliac joint fixation.Business Wire 10.06.21
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MIS/Robotics | Spine/Neurology
SeaSpine Earns CE Mark for 7D Surgical Cranial, Percutaneous Spine Modules
7D FLASH Navigation System uses visible light to create a 3D image for surgical navigation in seconds.GlobeNewswire 09.29.21
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Spine/Neurology
NASS News: Intelivation Technologies to Launch Cervical Interbody Fusion Device
The Advantage-C PEEK Cervical device was developed to optimize fusion while maintaining elasticity.Intelivation Technologies 09.24.21
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Medical Device IP Strategy, Part II: Creating a Patent Strategy to Mitigate Risk
U.S. patent law establishes the right of a patent owner to prevent others from making, using, selling, offering for sale a product claimed in a valid patent.Gregory Grissett, Principal and Chair, Intellectual Property Group, Offit Kurman P.A. 09.14.21
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Biologics
Anika's Tactoset Nabs Additional FDA OK for Hardware Augmentation
Expands capability of Tactoset injectable bone subsititute for augmenting suture anchor fixation.GlobeNewswire 09.14.21
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Spine/Neurology
FDA OKs joimax's EndoLIF Delta-Cage, DoubleWedge-Cage
For intervertebral body fusion procedures for various diseases of the lumbar spine.Business Wire 09.08.21
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3-D Printing/Additive Mfg. | Extremities | Software & Quality
FDA OKs In2Bones' Total Ankle Planning Software, Cutting Guides
Pre-surgery OrthoPlanify patient-specific planning software, 3D-printed cutting guides for QUANTUM total ankle.Business Wire 09.01.21
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Large Joint
Zimmer Biomet, Canary Medical Persona IQ Smart Knee Earns FDA Nod
Post-op gait metrics to provide real-world, objective patient data.Zimmer Biomet 08.30.21
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Spine/Neurology
FDA Approves First-of-Its-Kind Vivistim Stroke Rehab System
Electrically stimulates vagus nerve to reduce deficiencies in upper limb and extremity motor function.U.S. Food and Drug Administration 08.30.21
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Large Joint
FDA Clears Fuse Medical's Sterizo Revision Knee, PS Tibial Insert
Latest additions to the Sterizo Total Knee System.Business Wire 08.27.21
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Extremities
FDA OKs FX's Lateralized and Augmented Glenoid Baseplates
FX brings ten additional glenoid baseplate options to the market.PR Newswire 08.27.21
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Extremities
FDA OKs Shoulder Innovations' InSet Reverse Shoulder
Features AI-enabled 3D PreView Software Planning solution.PR Newswire 08.23.21
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Large Joint | MIS/Robotics
FDA OKs Zimmer Biomet's ROSA Hip
Cleared for robotically-assisted direct anterior total hip arthroplasty.PR Newswire 08.18.21
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MIS/Robotics | Spine/Neurology
FDA OKs Globus Medical's Excelsius3D
Consolidates 360-degree cone-beam CT, fluoroscopy, high-resolution digital radiography.GlobeNewswire 08.17.21
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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
