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.
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.
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.
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 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.
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.
OrthoSensor was granted FDA 510(k) clearance for Alignment capabilities with VERASENSE™ Sensor-Assisted Technology for use with Zimmer Biomet's Persona Knee.
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.
Nextremity Solutions received FDA 510(k) clearance to market the InCore® TMT system, a three-part construct for fixation for Lesser Tarsometatarsal Joint Arthrodesis.
DeGen Medical received FDA clearance to market the F1 MPS Modular Pedicle Screw System for JOUST Minimally Invasive Surgery and the Cyclops Anterior Cervical Plate.
Viseon announced FDA 510(k) clearance and initial clinical use of Voyant high-definition real-time imaging technology for minimally invasive spine surgery.
With the NASS 2019 Annual Meeting approaching, it's an ideal time to revisit spine products that have gained FDA 510(k) clearance in the first half of the year. This round-up shares another entrant into the sacroiliac joint treatment arena, an implant company's first clearance for an enabling technology and additional details about some lesser-known companies to watch.
With the NASS 2019 Annual Meeting approaching, it's an ideal time to revisit spine products that have gained FDA 510(k) clearance in the first half of the year. This round-up shares another entrant into the sacroiliac joint treatment arena, an implant company's first clearance for an enabling technology and additional details about some lesser-known companies to watch.
Konica Minolta Healthcare Americas received FDA 510(k) clearance to market Dynamic Digital Radiography enhanced x-ray imaging that can capture movement in a single exam.
Small companies around the world continue to seek access to the expansive U.S. market. In 2018, 42 companies received their first ever orthopedic-related FDA 510(k) or first FDA 510(k) in a new market segment. The companies and products we mention here are excerpted from chapters of the upcoming 2019 installment of THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT.
Medicrea enhanced the UNiD ASI (Adaptive Spine Intelligence) platform with addition of a device selection and surgical planning service, integrating a complete database of all Medicrea spine implants.
SI-BONE received an additional FDA 510(k) clearance for use of iFuse Bedrock technology in fusion of the sacroiliac joint during long construct procedures.
Nextremity Solutions received FDA 510(k) clearance to market Stratum, a comprehensive system of plates indicated for fixation of small bones and bone segments in the foot.
SpineEX gained additional FDA clearance for the Sagittae Lateral Lumbar Interbody Fusion system, covering new instrumentation and an updated surgical technique.
Nvision Biomedical Technologies received FDA 510(k) clearance to market the Vector Hammertoe Correction System, the first foot/ankle implant made from PEEK.
Alphatec received FDA 510(k) clearance to market automated SafeOp neuromonitoring for use in real-time intra-op nerve location and health assessment. Commercial launch will occur within 1H19.
NuVasive received FDA 510(k) clearance and CE Mark approval to market Precice® Bone Transport, an all-internal treatment for segmental bone loss in the tibia and femur.
Gramercy Extremity Orthopedics received FDA 510(k) clearance for its GEO® Nitinol Staple for fixation of small bone fragments, osteotomies and joint arthrodesis.
OSSIO received FDA 510(k) clearance to market OSSIOfiber bone pins, made of a bio-integrative material designed to provide stability and secure bone fixation that will leave no hardware behind.
Spinal Elements received additional FDA 510(k) clearance for claims related to the macro-, micro- and nano-surface structure of its Ti-Bond® surface coating technology.
Medacta received FDA 510(k) clearance to market the GMK® Sphere “ Kinematic Alignment surgical technique and technique-specific instruments for total knee arthroplasty.
FDA approved an update to the labeling for Zimmer Biomet's Mobi-C® Cervical Disc to include 7-year clinical results, showing the device to be statistically non-inferior in overall study success for 1-level use and statistically superior in overall study success for 2-level use.
Synergy Biomedical received FDA 510(k) clearance and commenced full launch of BIOSPHERE® MIS PUTTY for open, mini-open and percutaneous minimally invasive procedures.
Meditech Spine gained FDA 510(k) clearance to market the CURE Opel-C Plate implant system, an add-on technology to its CURE anterior cervical plate system and Talos-C HA interbody systems.
Field Orthopaedics received FDA 510(k) clearance to market a micro screw system for fixation of fractures, osteotomies and arthrodeses of small bones in the foot, hand and forearm.
OrthoPediatrics announced an additional FDA 510(k) clearance for the FIREFLY® Pedicle Screw Navigation Guide to include S2AI screw trajectory for sacral-iliac fixation in complex spinal reconstruction.
Vallum received FDA 510(k) clearance to market a PEEK interbody fusion device with a PEEKplus® nanotextured surface created with proprietary Accelerated Neutral Atom Beam technology.
Lipogems received FDA 510(k) clearance to market a Microfragmented Adipose Tissue Transplant system for use in orthopaedic and arthroscopic procedures.
To meet your need to know who's new in the orthopaedic market, I sorted through the 21 companies receiving their first orthopaedic-related FDA 510(k) clearance through May of this year. To keep things simple, I then chose one company from each implantable market segment for a closer look. Here's what I found.
Tenon Medical received FDA 510(k) clearance to market the Catamaran Sacroiliac Joint Fixation system, indicated for sacroiliac joint fusion to treat joint disruptions and degenerative sacroilitis.
Wright Medical received FDA premarket approval for AUGMENT® Injectable Bone Graft, serving as an alternative to autograft in hindfoot and ankle fusion.