Spinal Fusion

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.

SI-BONE Files for Proposed IPO

SI-BONE publicly filed for a proposed IPO, and applied to list on NASDAQ as SIBN. Proceeds will primarily support commercialization activities for the iFuse implant for treatment of SI joint dysfunction.

Strategic Orthopaedic-related 510(k)s Issued in June 2017: Hip Recon and Spine Devices

Strategic orthopaedic-related 510(k)s issued in June 2017 include: Telix K Interbody System (Biedermann Motech); iTotal Hip Replacement (ConforMIS); Tranquil Interbody System (Nexus Spine); PHA S1 Spinal System (Phamedica); Total Hip Arthroplasty Device (Responsive Orthopedics/Medtronic); Interbody Fusion System (Spinal Analytics & Geometrical Implant); Channel Cervical Interbody System (Summit Spine); Coalesce Lumbar Interbody Fusion System (Vertera Spine)

Strategic orthopaedic-related 510(k)s issued in January 2017

Strategic orthopaedic-related 510(k)s issued in January 2017 include: Fibulink Syndesmosis Repair Kit (Akros Medical), Anatomic Total Knee (Amplitude), Facilis Pedicle Screw System (Baui Biotech), GEO Bone Screw (Gramercy Extremity Orthopedics), Roccia ACIF Intervertebral Fusion System (Silony Medical), Fitbone TAA Intramedullary Lengthening System (Wittenstein Intens)

Strategic Orthopaedic-related 510(k)s issued in July 2016

Strategic orthopaedic-related 510(k)s issued in July 2016 include: Integra External Fixation System (Ascension Orthopedics/Integra); CorticaLink Spinal Fusion Platform (FacetLink dba LinkSpine); Lumbar Interbody Fusion Device (Keos*); MectALIF Anterior Standalone Intervertebral Fusion Device (Medacta); Cure Anterior Cervical Plate (Meditech Spine); Cannulated Screw (Miami Device Solutions); Belvedere Lateral Plating System (NeuroStructures); NEO Arthroscope (Prosurg)