Tag: PEEK
Curiteva announces FDA 510(k) clearance for Inspire 3D porous PEEK HAFUSE...
Curiteva has received the 510(k) clearance from the US Food and Drug Administration (FDA) for its 3D printed PEEK implant, the Inspire porous PEEK...
HAPPE Spine announces additional patents for hydroxyapatite porous polyetheretherketone devices
HAPPE Spine has announced the addition of two more issued patents in a growing portfolio of next generation orthopaedic and spinal implants enabled by the...
Nexxt Spine reveals early clinical evidence and completes enrolment for Nexxt...
Nexxt Spine has announced the completion of enrolment and six-month clinical data collection comparing the Nexxt Matrixx 3D-printed titanium interbody family to polyetheretherketone (PEEK)...
Tritanium posterior lumbar cage an ‘effective alternative’ to PEEK cages for...
For the treatment of degenerative disc disease (DDD), the Tritanium posterior lumbar cage (Stryker) is an effective alternative to polyetheretherketone (PEEK) cages, with higher...
HAPPE Spine announces new additions to board of directors
HAPPE Spine has announced two new additions to its board of directors following a US$3.35 million Series A financing round, the funds of which will be...
HAPPE Spine raises US$3.35 million to launch new interbody spinal fusion...
HAPPE Spine has announced the closure of a US$3.35 million Series A funding round, the proceeds of which will be used to help launch...
NuVasive launches latest porous PEEK implant for posterior spine surgery
NuVasive has announced the launch of its Cohere TLIF-O implant as well as the upcoming launch later this year of the Cohere TLIF-A implant....
Intelivation Technologies receives FDA approval for Advantage-C PEEK cervical interbody fusion...
Intelivation Technologies has received US Food and Drug Administration (FDA) 510(k) clearance of the Advantage-C PEEK cervical interbody fusion device, which is designed to be...
PEEK-on-ceramic TDR is a ‘viable alternative’ to ACDF for single-level symptomatic...
Polyetheretherketone (PEEK)-on-ceramic total disc replacement (cTDR) is a viable treatment for symptoms related to cervical disc degeneration and offers similar or superior outcomes compared with fusion, according...
Zavation Medical Products launches the Labyrinth fully porous PEEK cage
Zavation Medical Products has announced the launch of Labyrinth, a porous PEEK interbody cage. This is the latest addition to Zavation’s portfolio, which the...
BlackArmour anterior cervical plate launched in the US market
icotec ag has announced the US market release of its BlackArmor carbon/PEEK implants. According to a company press release, it is the world’s first...
Nanocoated PEEK cages improve osseointegration in PLIF procedure
Investigators have found that nanocoated polyetheretherketone (PEEK) cages for posterior lumbar interbody fusion (PLIF) achieve a better fusion rate than uncoated PEEK cages at...
Icotec earns FDA clearance for pedicle screw system
The US Food and Drug Administration (FDA) has granted Swiss devicemaker Icotec 510(k) clearance for its VADERone pedicle screw system, used for minimally-invasive and...
New product innovation award for PEEKplus
Based on its recent analysis of the North America spinal fusion device performance enhancers market, Frost & Sullivan recognises Vallum with the 2018 North America...
Bio2 Technologies receives FDA IDE approval to begin clinical study of...
Bio2 Technologies, a privately held orthopaedics company, has announced that it received US Food and Drug Administration (FDA) approval to begin enrolment in an...
First patient enrolled in clinical trial evaluating the Simplify artificial cervical...
Connecticut Orthopaedic Specialists have announced the enrollment of the initial patients within Simplify Medical’s clinical trial to evaluate the Simplify Disc, its novel investigational...
FDA clears first nanotechnology PEEK devices for spinal intervertebral fusion
The US Food and Drug Administration (FDA) has granted approval to market a polyetheretherketone (PEEK) spinal interbody fusion device with a PEEKplus nanotextured surface...
SpineFrontier receives FDA approval for A-CIFT SoloFuse HA standalone system
The A-CIFT SoloFuse HA (SpineFrontier) has received FDA approval.
The company states that the A-CIFT SoloFuse HA standalone system was produced “to leverage the familiarity...
First porous PEEK spinal implant clinical study validates its use in...
Porous polyetheretherketone (PEEK) technology (NuVasive) is a clinically viable alternative for improving osseointegration and fusion rates of interbody implants to treat degenerative cervical disc...
icotec receives FDA clearance to market BlackArmor® Carbon/PEEK interbody cages
The latest line of icotec interbody cages, designed to optimise bony integration and post-operative visualisation, has received US Food and Drug Administration (FDA) 510(k)...
Rampart One standard ALIF interbody fusion system gains FDA clearance for...
The Rampart One Standard anterior lumbar interbody fusion (ALIF) device (Spineology) has been granted FDA clearance, allowing it to be used with or without...
FDA 510(k) clearance for cervical and lumbar HA PEEK interbody...
The US Food and Drug Administration (FDA) has granted 510(k) clearance for both the ALTA ACDF interbody spacers (Astura Medical) and HALF DOME lumbar...
Camber Spine announces 510(k) approval of ENZA-A titanium ALIF
The US Food and Drug Administration (FDA) has given 510(k) clearance to Camber Spine to market its ENZA-A titanium anterior lumbar interbody fusion (ALIF)...
Research shows NuVasive porous PEEK structure maintains high porosity after impaction
The NuVasive porous polyether-ether-ketone (PEEK) material shows minimal surface damage upon impaction compared to titanium-coated devices, concludes a study recently published in The Spine...
Simplify Medical closes additional US$23.25 million in second tranche of series...
Simplify Medical, a company focused on cervical spinal disc arthroplasty and maker of the Simplify cervical artificial disc, has announced a second tranche of...
NuVasive extends porous PEEK interbody to TLIF and PLIF procedures
NuVasive announced on 4 January the launch of the company’s Coalesce Thoracolumbar Interbody Fusion Device as well as FDA 510(k) clearance for expanded indications of...
US FDA clears Vertera Spine’s porous PEEK Coalesce LIF device
Vertera Spine has announced that the company’s Coalesce lumbar interbody fusion device has received US Food and Drug Administration (FDA) 510(k) clearance for use...
Meditech Spine lumbar fusion devices receive US FDA clearance
Meditech has announced the launch of its Talos lumbar interbody fusion device comprised of PEEK hydroxyapatite (PEEK-Optima HA Enhanced, Invibio Biomaterial Solutions)—the newest generation...
Innovasis recieves FDA 510(k) clearance for PEEK standalone Ax ALIF System
Innovasis has become the first company to recieve US Food and Drug Administration (FDA) clearance for a standalone anterior lumbar interbody fusion (ALIF) system...
Porous PEEK demonstrates greater osseintegration than micro-textured titanium
The virtues of polyetheretherketone (PEEK) as a material for spinal implants are well documented. PEEK’s radiolucency along with its similar strength and stiffness to...
First patient treated with Simplify disc in US pivotal trial
Simplify Medical has announced that the first patient has been treated in the company’s pivotal clinical trial studying use of the Simplify disc in...
Spinal Elements Magnum+ achieves 96% solid fusion at seven months
Data obtained from a retrospective study involving the Spinal Elements’ Magnum+ device used in anterior lumbar interbody fusion have demonstrated a 96% rate of...
Surface innovation in spinal technology
Surface technology for interbody fusion implants is an area of massive growth in the spinal market, with a large number of device companies and...
Successful early outcomes reported for Vertera Cohere fusion device
The first early successful outcomes using the Cohere cervical interbody fusion device have been reported by Vertera Spine.
Cohere is Vertera Spine's first device featuring...
SeaSpine receives two US FDA 510(k) clearances
SeaSpine has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Shoreline ACS anterior cervical standalone system, featuring TruProfile technology,...
Spineology announces FDA clearance of Rampart Duo interbody fusion system
The US Food and Drug Administration (FDA) has given clearance to Spineology’s Rampart Duo interbody fusion system. The Rampart Duo device is the first...