Comprising polyaxial screws, hooks, rods, locking screw assemblies and connectors, Sochi OCT may be rigidly locked to promote fusion for a variety of anatomies.
Xenco announced FDA clearance and launch of its Multilevel CerviKit, implants and single-use instruments for 2, 3 and 4 level anterior cervical spine procedures.
CoNextions was granted FDA 510(k) clearance to market the CoNextions TR® Tendon Repair System. Expected to launch in May 2022, the novel system addresses traumatic tendon lacerations in the hand, wrist and forearm....
Designed for complex limb reconstruction and deformity correction, the system features radiolucent rings and struts for clear visualization under x-ray.
These new plates integrate with GEO's current system, utilizing the same single-use sterile instrument kits and screws that are brought to market with the GEO Cart.
Proposed indications include filling of bony voids and gaps, and protecting against microbial colonization while granules resorb and are replaced with bone.
The supplemental approval order allows the Patient Specific Talus Spacer to be additively manufactured in titanium alloy with a titanium nitride coating.
The 3-in-1 platform consolidates 360 cone-beam CT, fluoroscopy and high-res digital radiography, eliminating the need for multiple imaging systems in one procedure.
The clearance is the first in the world using Aurora's proprietary DEXA Technology for custom made implants based upon matching patient's bone density.
This is the first closed-loop suture fixation for soft tissue to soft tissue repair of certain types of injuries, designed for less-invasive procedures.
Micromate, available in the U.S. spine fusion landscape through partner company Fusion Robotics, can perform almost every non-invasive image-guided procedure.
The new offering, part of the ELEOS Limb Salvage System, is designed to support bone ingrowth in musculoskeletal oncology and complex orthopaedic limb salvage cases.
Neo received 510(k) clearance and approval under the CE Mark for the system plus BonOs Inject cement from OSARTIS in an advanced stage tumor indication.
The compatibility of Medicrea UNiD Rods with Medtronic's spinal systems supports integration of AI-driven surgical planning, robotic assisted surgery, etc.
THINK Surgical and Ortho Development gained FDA clearance for use of the Balanced Knee System and BKS TriMax Implants with the TSolution One Total Knee Application Active Robot.
The press uses a 2-step technique to harvest autologous material during bony decompressions such as laminectomy, vertebral corpectomy, foot/ankle surgery, etc.
Key potential benefits cited in the application include less invasive/shorter surgery, improved outcomes, reduction of hospitalization length of stay, etc.
APOLLO is part of the DEXA portfolio, positioned to reshape the market through patent focused innovation and address the next advancement in spine surgery.
Loop-X is the first fully robotic mobile intra-op imaging device on the market, and Cirq Robotic Alignment will be used with Brainlab navigation software.
SeaSpine is permitted to describe the surface technology as offering a "microscopic roughened surface with nano-scale features” and amends indications across 12 implant systems.
The company's AI solution extracts 3D bone reconstruction from x-ray scans at the same quality as CT, enabling use of standard X-rays for surgery planning.
The HiRise weight bearing CT imaging system addresses all orthopedic lower extremity applications, and can scan anywhere from the hip & pelvis to the feet.
VADER is designed to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors.
To clear regulatory issues related to its purchase of Wright Medical, Stryker proposed DJO as a buyer for certain ankle and finger joint replacement lines.
FDA granted Breakthrough Device Designation for CartiHeal's Agili-C implant™, a cell-free implant for treatment of cartilage and osteochondral defects.
3D GraftRasp is the only device to receive FDA clearance for both decortication of bone and the delivery of autograft, allograft or synthetic bone graft.
Only CurveBeam systems offer a wide platform that lets patients stand naturally during a scan along the lower extremity from the hip & pelvis to the feet.
Canada will be the first commercial market to launch i-FACTOR+ Matrix. The technology is currently being studied in an FDA IDE trial targeting lumbar fusion.
The designation and funding from the U.S. DoD will accelerate R&D for the mechanically functional total meniscus replacement that is resorbed by the body.
The Kiva Vertebral Compression Fracture Treatment is a unipedicular PEEK implant-based solution that has seen clinical and commercial success in the U.S.
The Intracs em Navigation System allows for spinal procedures to be carried out with minimal X-ray control, reducing radiation exposure and access time.
The IDE Supplement allows for a reduction in the number of patients required to be enrolled in the ASPIRE IDE Study on P15-L bone graft in the lumbar spine.
The JuniOrtho system is now FDA 510(k) cleared and has CE Mark approval supporting advanced deformity and trauma reconstruction of the lower extremities in pediatric patients.
The clearance addresses primary and revision hip procedures. The system can be used with a variety of surgical approaches and most implants on the market.
CUVIS-spine guides and supports the pedicle screw to the correct position using a robotic arm, one-step surgical tools and a real-time location sensor.
The AMS implant portfolio includes proprietary surface and structural technologies to enhance biomechanical properties of materials for spine procedures.
The clearance addresses implant and instrument additions to the system. ARx is Life Spine's fourth 510(k) clearance in 2020 with 92 total since inception.
With the V-STRUT system, two PEEK polymer implants are inserted in the vertebral body through the pedicles and combined with PMMA bone cement to treat VCFs.
The prodisc line now comprises six devices, including an anterior and anterior-lateral approach lumbar disc replacement and four cervical disc implants.
Signus Medizintechnik announced CE Mark approval for the BIG® ST ALIF Cage and JASPIS® ST Cervical Cage, additions to the company's Structural Titanum portfolio of 3D-printed cages.
OrthoSensor was granted FDA 510(k) clearance for Alignment capabilities with VERASENSE™ Sensor-Assisted Technology for use with Zimmer Biomet's Persona Knee.
AgNovos Healthcare was granted Breakthrough Device Designation by FDA for the AGN1 Local Osteo-enhancement Procedure Small Volume Kit for the treatment of vertebral compression fractures.
Medacta received FDA 510(k) clearance to market the MectaLock All-Suture Anchor, MectaTap TI Suture Anchor and Mectafix CL Fixation Button with Continuous Loop.
Medacta gained CE Mark approval for several of its sports medicine devices, and marked multiple first sports medicine procedures in Australia and the U.S.
Silver Bullet Therapeutics received CE Mark approval for the OrthoFuzIon™ Bone Screw for reduction and internal fixation procedures anywhere in the body.
Carmell Therapeutics announced FDA clearance of an Investigational New Drug application for the company's Bone Healing Accelerant and enrollment in a pivotal study for long bone fractures.
Episurf Medical received an additional patent in China relative to the Episealer® Femoral Twin joint implant design process and expects to obtain CE Mark Approval for the Episealer Talus ankle implant.
Nextremity Solutions received FDA 510(k) clearance to market the InCore® TMT system, a three-part construct for fixation for Lesser Tarsometatarsal Joint Arthrodesis.
FDA approved Cerapedics' Premarket Approval supplement for i-FACTOR® Peptide Enhanced Bone Graft for use in ACDF to treat degenerative cervical disc disease.
Garwood Medical Devices was granted a Breakthrough Device designation from FDA for BioPrax™, an electrical stimulation tool to help eliminate biofilm infections on knee implants.