Spinal Fusion

Nexus Spine Launches Novel Spinal Implants

Nexus Spine Launches Novel Spinal Implants
The novel compliant-mechanism based systems include PressON patient-specific fixation and the flexible titanium Tranquil device for interbody fusion.

OrthoPediatrics Expands Network in Europe

OrthoPediatrics Expands Network in Europe
OrthoPediatrics broadened its reach in Germany, Austria and Switzerland by converting long-standing distributor partners to sales agencies.

Study Validates NuVasive X360 Approach

Study Validates NuVasive X360 Approach
The single position circumferential fusion was found to improve operative efficiency and reduce complications vs. traditional circumferential fusion.

Aurora Spine Debuts Pain Care Division

Aurora Spine Debuts Pain Care Division
The division will assist pain management physicians who seek to reduce use of opioids and increasingly use mechanical devices like the ZIP and SiLO.

Astura Medical Receives FDA 510(k) Clearance For Dolomite Stand-Alone Anterior Cervical Stabilization System

Astura Medical Receives FDA 510(k) Clearance For Dolomite Stand-Alone Anterior Cervical Stabilization System
Astura Medical was granted FDA 510(k) clearance to market the Dolomite Stand-Alone Anterior Cervical Stabilization System. Dolomite is the company's third technology providing a combined interbody and fixation option to receive 510k approval within the last 6 months....

FzioMed Reaches Oxiplex 600K Unit Milestone

FzioMed Reaches Oxiplex 600K Unit Milestone
Oxiplex absorbable gel is applied to neural tissues following spine surgery, creating a temporary barrier between adjacent tissues.

Spineart Conducts Ti-LIFE Animal Study

Spineart Conducts Ti-LIFE Animal Study
Ti-LIFE Technology is an enhanced algorithm for additive manufacturing of titanium cages resulting in structures with a bone-like matrix.

Aurora Spine Issued Patent for DEXA Technology

Aurora Spine Issued Patent for DEXA Technology
The U.S. patent, "Body Density Scan Result-Matched Orthopedic Implants and Methods of Use,” relates to DEXA technology patient-matched implant technology.

WishBone on a Mission to Bridge the Gap in Pediatric Orthopedics

WishBone on a Mission to Bridge the Gap in Pediatric Orthopedics
CEO Nick Deeter says that 95% of children continue to receive adult orthopedic products that were never intended for them nor cleared by FDA for use in children. WishBone seeks to change the paradigm of pediatric orthopedics with its child-focused implants and sterile packaged disposable kits.

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Implanet JAZZ Cap Patented in Japan

Implanet JAZZ Cap Patented in Japan
JAZZ Cap pedicle screw fixation technology is now protected in the United States, Europe and Japan. JAZZ Cap is CE Mark approved and FDA 510(k) cleared.

HAPPE Spine Gains Additional U.S. Patent

HAPPE Spine Gains Additional U.S. Patent
The patent claims provide broad protections for material and manufacturing that support fully porous, bioactive polyetheretherketone technology.

Providence Medical Enrolls in FUSE IDE Study

Providence Medical Enrolls in FUSE IDE Study
FUSE is designed to demonstrate superiority of Circumferential Cervical Fusion vs. traditional ACDF in patients at high risk for nonunion or revisions.

Augmedics xvision Used in First U.S. Spinal Fusion

Augmedics xvision Used in First U.S. Spinal Fusion
Surgeons used the augmented reality system to visualize anatomy with simulated “x-ray vision” and to accurately guide instruments and implants.

Precision Spine Launches Slimplicity HP Anterior Cervical Plate

Precision Spine Launches Slimplicity HP Anterior Cervical Plate
Precision Spine commenced U.S. launch of the Slimplicity® HP Anterior Cervical Plating (ACP) System, which accommodates diverse patient anatomies and pathologies with low profile constrained, semi-constrained or hybrid constructs....

NuVasive Issues Field Safety Notice for MAGEC System

NuVasive Issues Field Safety Notice for MAGEC System
NuVasive voluntarily issued an Urgent Field Safety Notice in the U.K. and Ireland to address concerns identified by The Medicines and Healthcare Products Regulatory Agency over continued use of the MAGEC device for the treatment of scoliosis.

INSPAN Reports Study Results from Inspan Interspinous Fixation Device

INSPAN Reports Study Results from Inspan Interspinous Fixation Device
INSPAN announced successful results from a long-term follow-up clinical study of outpatient L4-L5 lumbar interspinous fixation for degenerative spinal stenosis using the Inspan® ScrewLES™ Fusion interspinous fixation device.

Tenon Medical’s Catamaran SI Fixation Study Results

Studies indicate that Tenon Medical's Catamaran™ Sacroiliac Joint Fixation System demonstrated an over 85% reduction in SIJ pain at six weeks, with radiographic evidence of solid continuous bridging bone across the treated joint at six months.

SpineCraft Launches ASTRA OCT Spine System

SpineCraft completed the ASTRA product platform with launch of its Occipito-Cervico-Thoracic system for use in posterior cervical fusion.

Study Results: RTI Surgical’s TETRAfuse 3D PEKK Technology

Studies show that RTI Surgical's TETRAfuse® PEKK implants demonstrated bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, a significant increase in bony apposition over time and a significantly higher push-out strength vs. standard PEEK.

CIGNA Establishes Positive Coverage for MIS SI Joint Fusion

CIGNA Establishes Positive Coverage for MIS SI Joint Fusion
CIGNA announced a positive coverage policy for minimally invasive sacroiliac joint fusion exclusive for FDA-cleared implants that are placed across the SI joint, such as SI-BONE's iFuse Implant System.

DePuy Synthes Launches SYMPHONY OCT System

DePuy Synthes launched the SYMPHONY Occipito-Cervico-Thoracic System, expanding its offering for the treatment of conditions in the neck and upper spine.

Implanet Granted Patent in Japan for JAZZ Lock

Implanet was granted a patent in Japan for JAZZ Lock® technology, part of its JAZZ™ solutions platform to treat degenerative spine disorders.

The Spine Market: A Look at Past and Forecasted Performance

Spine is the largest individual segment that we track, accounting for 18.2% of the orthopedic industry's overall revenue. Excluding biologics, sales of orthopedic spine products topped $9.3 billion in 2018, growing +2.7% vs. 2017. Growth in the segment exceeded our expectations, as several companies in the top 10 posted double-digit increases that offset lower performance by manufacturers at the top of the list. Here, we take a deeper look at past, present and forecasted performance.

FDA 510(k) Recap: Spinal Devices and Technologies from 1H19

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.

Alphatec Launches InVictus Spinal Fixation

Alphatec commenced commercial release of InVictus, a spinal fixation platform to treat a range of pathologies via MIS, open or hybrid surgical approaches.

joimax Launches EndoLIF Line

joimax commenced launch of the complete line of EndoLIF® devices for lumbar interbody fusion.

SI-BONE’s iFuse Surpasses 40,000 Procedures

SI-BONE's iFuse Implant System®, introduced in 2009, has been used in >40,000 SI joint fusion procedures by more than 1,900 surgeons worldwide.

Medicrea Awarded Additional U.S. Patents

Medicrea was allowed three new U.S. patents relating to the company's proprietary UNiD® Adaptive Spine Intelligence software platform.

M&A Recap: Three 2Q Announcements in Spine

Of the 20 OEM-related M&A announcements we've covered in 2019 thus far, seven have related to the spine market. Of those, three were announced in rapid succession within this quarter. Let's see who bought whom, and what they got: Medtronic/Titan Spine, Boston Scientific/Vertiflex and WishBone Medical/CSpine.

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ApiFix Completes Series B Financing

ApiFix completed its Series B financing round and is preparing for U.S. commercial launch of its MID-C System to treat pediatric scoliosis.

NuVasive Cohere Porous PEEK Comparative Study Results

NuVasive's Cohere® Porous PEEK interbody demonstrated clear benefits in promoting improved early outcomes in ACDF procedures when compared to both structural allograft and smooth PEEK.

SpineEX Issued New U.S. Patent

SpineEX was issued its second U.S. patent, addressing a novel mechanism to adjust posterior and anterior sides of an interbody fusion device independently of each other.