Tag: PEEK

Simplify Disc

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...
nanotechnology

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...
FDA A-CIFT SoloFuse HA standalone system

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...
Vertera Spine Cohere

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...
Vertera Spine Cohere

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...