510(k) Clearance

DeGen Medical Gains New FDA Clearances

DeGen Medical received FDA clearance to market the F1 MPS Modular Pedicle Screw System for JOUST Minimally Invasive Surgery and the Cyclops Anterior Cervical Plate.

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.

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.

Regulatory Report: 42 Companies that Received their First Orthopedic-Related FDA 510(k) in 2018

Small companies around the world continue to seek access to the expansive U.S. market. In 2018, 42 companies received their first ever orthopedic-related FDA 510(k) or first FDA 510(k) in a new market segment. The companies and products we mention here are excerpted from chapters of the upcoming 2019 installment of THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT.

Alphatec Gains FDA Clearance for SafeOp Neuromonitoring

Alphatec received FDA 510(k) clearance to market automated SafeOp neuromonitoring for use in real-time intra-op nerve location and health assessment. Commercial launch will occur within 1H19.

OSSIO Gains FDA Clearance for OSSIOfiber Bone Pin

OSSIO received FDA 510(k) clearance to market OSSIOfiber bone pins, made of a bio-integrative material designed to provide stability and secure bone fixation that will leave no hardware behind. 

FDA Approves Update of Mobi-C Cervical Disc Labeling to Include 7-Year Clinical Results

FDA approved an update to the labeling for Zimmer Biomet's Mobi-C® Cervical Disc to include 7-year clinical results, showing the device to be statistically non-inferior in overall study success for 1-level use and statistically superior in overall study success for 2-level use.

FDA 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances

To meet your need to know who's new in the orthopaedic market, I sorted through the 21 companies receiving their first orthopaedic-related FDA 510(k) clearance through May of this year. To keep things simple, I then chose one company from each implantable market segment for a closer look. Here's what I found.

Globus Medical Unveils FDA-Cleared Trauma Products

Globus Medical debuted its FDA-510(k)-cleared trauma products, comprising fracture plates, compression and cannulated screws, intramedullary nails and external fixation. 

Strategic Orthopaedic-related 510(k)s Issued in July 2017: Interbody Focus

Strategic orthopaedic-related 510(k)s issued in July 2017 include: EIT Cellular Titanium Cages (EIT Emerging Implant Technologies), Lumbar Interbody System (HD LifeSciences), Gemini-C Hybrid Cervical Interbody System (Osseus Fusion Systems), LumFuse-TP (Precifit Medical), Anchorman Tibial Ligament Fixation (Summit Medical)

Trauma and Spine Markets Gain New FDA Clearances

In 1H17, 23 orthopaedic companies from 11 countries received their first 510(k), according to FDA. We call your attention to these companies to assist you with identifying startups, as well as ex-U.S. companies entering the U.S. market.

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 May 2017

Strategic orthopaedic-related 510(k)s issued in May 2017 include: Locking Plate System (Beijing KeYi Medical Device), Collagen Meniscus Implant XL (Ivy Sports Medicine), Kirschner Wires (Precifit Medical), SICAGE System (Sicage), MALUC Total Hip Arthroplasty System (SurgTech)

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

Strategic orthopaedic-related 510(k)s issued in April 2017 include: ExactechGPS Total Shoulder Application (Exactech filing as Blue Ortho); Locking Bone Plates and Screws Osteosynthesis Plating System, DHS/Dynamic Condylar Plate (Greens Surgicals); AX Standalone ALIF System (Innovasis); Mazor X (Mazor Robotics); PRECICE UNYTE CoCr System (NuVasive Specialized Orthopedics); NovoGro Putty (OsteoNovus); Balanced Plating System (Pantheon Medical); Yellowstone Lumbar Interbody Fusion System (Summit Spine); XO1 Knee Balancing System (XpandOrtho)

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

Strategic orthopaedic-related 510(k)s issued in March 2017 include: Joinix Cannular System (Aju Pharm), Unicompartmental Knee (Bodycad), Microfet 2 Dynamometer (Hoggan Scientific), Flex-Thread Clavicle Pin (Intrafuse), Evolution Revision Tibial System (MicroPort Orthopedics)

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

Strategic orthopaedic-related 510(k)s issued in February 2017 include: NanoFuse (Amend Surgical*), Arrowhead Mini-Rail Fixator (Arrowhead), Expandable Interbody System (Atlas Spine), DCM Kyphoplasty System (Dragon Crown Medical*), Kepler I Cervical Plate (Orbbo Surgical), RASL Repair Kit/Bone Screw (Radicle Orthopaedics*), Trauma System/Plates and Screws (Surgtech), BluePrint Patient Specific Instrumentation (Tornier/Wright Medical), Intra Medullary Endo-Transilluminating Device/Arthroscope (Wemed Bio-Tech*), Prophecy INVISION Pre-operative Navigation Alignment System (Wright Medical), Magnetos Bone Void Filler (Xpand Biotechnology*)

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)

Year in Review: First 510(k)s in 2016

The following 18 companies received their first FDA 510(k) in 2016. Whats interesting is that some companies like CG Bio, Meril Life Sciences and Overmed were founded in 2006a decade ago. Another, such as Onkos Surgical, was founded as recently as 2015.

Strategic orthopaedic-related 510(k)s issued in December 2016

Strategic orthopaedic-related 510(k)s issued in December 2016 include: Envision 3D Image Guidance System (7D Surgical); Sphynx Anterolateral Plate (Eden Spine); Destiknee Total Knee (Meril Healthcare); Hubble II Lumbar Interbody Fusion System (Orbbo Surgical)

Strategic orthopaedic-related 510(k)s issued in November 2016

Strategic orthopaedic-related 510(k)s issued in November 2016 include: Preference Elite Pedicle Screw System (Amedica); Titanium Porous Fixation Device (Amorchem); Moss 100 Pedicle Screw System (Biedermann Motech); Persona Partial Knee (Biomet/Zimmer Biomet); AltiVate Anatomic Shoulder, Exprt Revision Hip (Encore Medical/DJO); Initia Total Hip & Bioceram AZUL Head (Kyocera Medical); Virtu C Spinal Implant (Met 1); Interference Screw (Nanova Biomaterials); Fortezza Spinal Stabilization System (Osso Surgical)

RTI Surgical Receives Additional 510(k) Clearance for Streamline OCT System

RTI Surgical received an expanded FDA 510(k) clearance for the Streamline OCT Occipito-Cervico-Thoracic System, including an indication for polyaxial screw placement in the cervical spine, and also clearance for a dual diameter transition rod.

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

Strategic orthopaedic-related 510(k)s issued in September 2016 include: Bone Wedge System (Additive Orthopaedics); Portage System - Arthroscope (Baylis Medical); Spinal Fixation System (Canwell Medical); Interform Cervical Interbody Cage (Next Orthosurgical); MAGEC Spinal Bracing and Distraction System (NuVasive Specialized Orthopedics); K-Wire and Pin System (Syntorr); mi-eye 2 Arthroscope (Trice Medical)

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

Strategic orthopaedic-related 510(k)s issued in August 2016 include: Xycor Expandable Spinal Spacer (Alphatec Spine); Valeo II Interbody Fusion Device (Amedica); Tarsa-Link Standalone Wedge, Hammertoe Correction System (Centric Medical/Life Spine); Universal Spine System (Double Medical Technology); Titan Reverse Shoulder (Integra LifeSciences); Virtu Lumbar Spacer (Met 1 Technologies*); Distal Radius Plating System (Miami Device Solutions); Response BandLoc Spinal Fixation (OrthoPediatrics)

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)