Copy to clipboard 
This month’s recap offers spinal fusion products from Curiteva and Providence Medical Technology, followed by bone grafts from SurGenTec and Ventris Medical.
Spine
Curiteva | Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion
Curiteva | Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion, K233744
Submitted November 2023, granted January 2024
Primary predicate: Curiteva Lumbar Interbody Fusion System, K181589
FYI: Indicated for use in anterior, transforaminal, posterior and lateral lumbar interbody fusion.
This marks the company’s second FDA-cleared 3D-printed PEEK implant with HAFUSE.
The Inspire platform is manufactured with a proprietary, patented Fused Filament Fabrication 3D printer that was designed, programmed and built by Curiteva. This additive process produces a fully interconnected and integrated trabecular PEEK lattice structure traversing the entire implant to promote osseointegration, improve radiographic assessment and deliver superior biomechanics. The combination of the HAFUSE nanotechnology surface treatment and trabecular PEEK structure creates a hydrophilic, bioactive environment for cell attachment, proliferation and healing in preclinical animal and in vitro studies.
The company plans a commercial introduction of Inspire for TLIF and PLIF procedures during 2Q24.
Providence Medical Technology | CAVUX FFS-LX: Lumbar Facet Fixation
Providence Medical Technology | CAVUX FFS-LX: Lumbar Facet Fixation, K230840
Submitted March 2023, granted December 2023
Primary predicate: Providence Medical Technology ALLY Facet Screws, K163374
FYI: This clearance marks the company’s expansion into the lumbar spine market. CAVUX FFS-LX was designed to offer increased stability following lumbar fusion to increase fusion rates and reduce complications and reoperations.
Summary clinical study data reviewed by FDA in considering the clearance included:
• 57 patients were evaluated with a median follow-up of 30 months. The median age was 45, the median body mass index was 30 and 68% of subjects reported nicotine use as a risk factor.
• 96% of levels were determined to be fused as defined by a range of motion less than 5° on flexion/extension x-rays assessed by an independent core imaging lab.
• Clinically meaningful improvement in pain was achieved in 79% of subjects.
Orthobiologics
SurGenTec | OsteoFlo HydroPutty Synthetic Bone Graft
SurGenTec | OsteoFlo HydroPutty Synthetic Bone Graft, K231716
Submitted June 2023, granted October 2023
Primary predicate: NovaBone Products NovaBone Putty, K110368
FYI: HydroPutty features a combination of proprietary hydrophilic carriers designed to absorb fluids such as bone marrow aspirate, blood or saline. This formula turns into a putty with ease of handling and has a resorption profile that’s optimized for bone growth.
This product can be packed into voids, resists irrigation and can be administered seamlessly through the Graftgun delivery system.
Ventris Medical | Amplify Synthetic Bone Graft Putty
Ventris Medical | Amplify Synthetic Bone Graft Putty, K240458
Submitted February 2024, granted March 2024
Primary predicate: NuVasive Attrax Putty, K203714
FYI: The subject device received marketing clearance in the intervertebral disc space. Amplify represents a new class of synthetic biomaterials designed for the optimization of cell proliferation and bone formation that comprises Amplify biphasic (HA/βTCP) ceramic granules suspended in an alkylene oxide polymer carrier. The device can be used alone or in combination with autograft bone (1:1 ratio) as a bone graft extender.
Amplify granules undergo a patented surface activation process that creates an encompassing network of polygonal microfilaments that extend from the granule surface. This advanced surface texture acts as a bio-instructive vector that can entrap critical healing elements and guide cellular processes. Activation of the granule surface network increases the surface area, porosity and dissolution rate of the granules to create more bioavailable surface interactions for cellular attachment, proliferation and remodeling.
The mineral component in Amplify comprises a hybrid mixture of surface-activated biphasic granules composed of two HA-to-βTCP blends that resorb at different rates. These surface-activated granules are derived from conventional HA/BTCP granules with ratios of 20/80 (faster resorbing) and 60/40 (moderate resorption), resulting in a bimodal dissolution profile that nourishes the fusion site in the early stages of healing and supports progressive bone remodeling throughout the fusion process.
The proprietary polymer blend in Amplify provides a cohesive, moldable matrix between the granules that facilitates accurate graft placement and containment at the defect site and that can readily be mixed with autograft bone. After implantation, this highly biocompatible polymer resorbs into the surrounding tissues, allowing immediate access to the activated biphasic granules and their healing effects.
