Trauma and Spine Markets Gain New FDA Clearances

By Julie A. Vetalice

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 that are entering the U.S. market. Nine of the 23 510(k)s were for trauma products and seven were spine; remaining clearances addressed reconstruction, arthroscopy equipment and biologics.

Of further note, many of the ex-U.S.-based companies receiving trauma and spine clearances have full portfolios in their respective market segments. With decades of experience, in some instances, we expect that these companies will seek additional FDA 510(k) clearances in an attempt to penetrate the U.S. market.

A full list follows with details on company location, background, market segment and 510(k).

Aju Pharm | Seoul, South Korea | Founded 1953
Segment: Arthroscopy/Soft Tissue

  • K162070: Joinix Cannular System
  • Joinix, comprising single-use cannula and trocar, facilitates entry into glenoid cavity during arthroscopic surgery
  • Medical device business focused on stem cells, wound, surgical and medical devices
  • Conducts business in ASEAN countries and China, Japan, Latin America, Middle East

Akros Medical | Durham, North Carolina, USA |Founded 2014
Segment: Trauma, Ankle

  • K162805, Fibulink Syndesmosis Repair Kit
  • Anchor to provide fixation between tibia and fibula after ankle syndesmosis
  • Raised $610K in 4Q15 from private investors

Amplitude | Valence, France | Founded 1997
Segment: Joint Reconstruction, Knee

  • K161414, Anatomic Total Knee for treatment of degenerative knee disease
  • Upon 1Q17 FDA 510(k) clearance, company stated that Anatomic had been used in >20,000 procedures in ex-U.S. launch
  • Claims 15% of French market for knee implants (second ranking behind Zimmer Biomet)

BAUI Biotech | New Taipei City, Taiwan | Founded 2009
Segment: Spine

  • K161231, Facilis Pedicle Screw
  • Indicated for spondylolisthesis of L5-S1 vertebra
  • Spine portfolio includes nearly 10 cervical and lumbar plates and cages

Beijing KeYi Medical Device
Beijing, China
Segment: Trauma

  • K162380, locking plate
  • Fixation for adult patients in ulna, radius, humerus, femur, tibia, fibula
  • Titanium-based, provided unsterilized

Bodycad | Quebec City, Canada | Founded 2011
Segment: Joint Reconstruction

  • K163700, Unicompartmental Knee
  • Proprietary 3D rending of patient’s anatomy used to develop patient-specific implant and instruments
  • System delivered as a “procedure in a box”
  • Launched in Europe in 2Q16

Dragon Crown Medical
Jinan, China
Segment: Spine

  • K162283, DCM Kyphoplasty System
  • Intended for reduction and fixation of spinal fractures
  • Company claims a “minimally invasive culture”

Gramercy Extremity Orthopedics | Richardson, Texas, USA | Founded 2014
Segment: Trauma

  • K161904, GEO Bone Screw
  • Indicated for fractures, osteotomies, arthrodesis, osteochondritis and tendon reattachment
  • Company founded to be cost effective, user-friendly manufacturer through delivery system and single-use implants and instruments

Greens Surgicals | Gujarat, India | Founded 1997
Segment: Trauma

  • K163383, Locking Bone Plates and Screws, Osteosynthesis Plating System, Dynamic Condylar Plate
  • Locking Bone Plates to treat clavicle, pelvis, scapula, long/small bones, etc.
  • Dynamic Condylar Plating System for fracture fixation of proximal femur shaft
  • Portfolio includes trauma, spine and joint recon products

IntraFuse | Logan, Utah, USA
Segment: Trauma, Clavicle

  • K163488, Flex-Thread Clavicle Pin
  • Stainless steel and PEEK, comprises a flexible threaded distal tip to engage the curved medial portion of the clavicle and a proximal cross screw to support stability and fixation to the lateral portion of the bone
  • Portfolio company of incubator Surgical Frontiers that will focus on less invasive intramedullary fracture fixation of clavicle, radius, ulna and fibula

OsteoNovus | Toledo, Ohio, USA | Founded 2013
Segment: Orthobiologics

  • K162087, NovoGro Putty
  • Synthetic bone void filler is claimed to support robust bone growth by six weeks; company has also developed granule and block formats
  • Technology licensed from University of Toledo; company is reportedly slated to close a partnership with an unnamed $100MM+ revenue company for non-exclusive private label sales of NovoGro

Pantheon Medical
Dallas, Texas, USA
Segment: Trauma 

  • K162154, Balanced Plating System
  • Titanium-based plates
  • Intended for fixation of fractures, revision procedures, joint fusion, non-unions and reconstruction of small bone extremities

Plainview, New York, USA | Founded 2014
Segment: Spine

  • K163011, PHA S1 Spinal System
  • System comprises titanium alloy polyaxial and monoaxial screws and reduction screws, rods, set screws, transverse/offset connectors
  • Indicated for multiple spine issues, including degenerative disc disease, spondylolisthesis, trauma and spinal stenosis

Radicle Orthopaedics
New York, New York, USA | Founded 2012
Segment: Trauma

  • K161334, RASL Repair Kit/Bone Screw
  • Designed to treat scapholunate ligament ruptures
  • Screw allows for 15 to 22 degrees of toggle angle and freely rotates
  • Company founded to develop trauma and extremities platform

SICAGE | Sioux Falls, South Dakota, USA | Founded 2015
Segment: Spine

  • K170475, SICAGE bone screw for sacroiliac (SI) joint disruptions and degenerative sacroiliitis
  • Fully-threaded titanium alloy bone screw is sold sterile and includes implants/instruments

Silony Medical | Frauenfeld, Switzerland | Founded 2012
Segment: Spine

  • K162587, Roccia ACIF Intervertebral Fusion System
  • Features wedge-shaped or anatomic Ti6AI4V-coated PEEK cage
  • Other products include Verticale, posterior double rod fixation system, and Ceracell Ortho, a silicon-doped B-TCP

Spinal Analytics & Geometrical Implant | London, United Kingdom
Segment: Spine 

  • K161710, SAGICO Interbody Fusion
  • System includes ARIA lumbar and ARION cervical implants made from PEEK (sourced from Invibio), titanium alloy (Dynamet) and tantalum beads/rods (X-medics)
  • Company’s full ex-U.S. range includes thoracolumbar fixation, anterior/posterior cervical, interbody fusion, biologics, vertebroplasty/kyphoplasty

Summit Spine
Georgetown, Texas, USA | Founded 2014
Segment: Spine

  • K170572, Yellowstone Lumbar Interbody Fusion System
  • Intended for one level or two contiguous levels to treat degenerative disc disease
  • Received second 510(k) in 2Q17 for Channel Cervical Interbody

Precifit Medical
Morrisville, North Carolina, USA
Segment: Trauma

  • K163327, Kirschner Wires
  • Stainless steel wire indicated for fixation of bone fractures, bone reconstruction and guide pins for insertion of other implants
  • Carolina China Council provided corporate relocation services to Precifit Medical, to relocate from China to Research Triangle Park

Wemed Bio-Tech | Taipei City, Taiwan
Segment: Arthroscopy/Soft Tissue

  • K163037, Intra Medullary Endo-Transilluminating Device/Arthroscope
  • Aids positioning of interlocking nails in distal screw holes by providing lighting devices; decreases radiation exposure by eliminating need for C-arms
  • Spun from Department of Biomedical Engineering at the National Yang Ming University

Wittenstein Intens | Igersheim, Germany | Founded 1999 (parent company 1949)
Segment: Trauma

  • K163368, Fitbone TAA Intramedullary Lengthening System
  • Intended for lengthening of the femur and tibia via a nail with a telescoping system powered by an electromagnetic motor
  • Other implants include custom-made lengthening systems

La Jolla, California, USA | Founded 2012
Segment: Joint Reconstruction, Knee

  • K162237, XO1 Knee Balancing System
  • XO1 is a sterile-packaged, wireless, disposable device compatible with nearly all total knee systems from major manufacturers to perform multiplanar balancing of the knee joint
  • Soft tissues can be released with the device in place, giving real time visual feedback to the surgeon; when the procedure is complete, the device preserves an electronic record of the entire 3D balance process
  • Clinical study underway; future development may address a range of orthopaedic procedures

Xpand Biotechnology (acquired by Kuros Biosurgery) | Bilthoven, The Netherlands | Founded 2004
Segment: Orthobiologics

  • K161859, MagnetOs bone void filler
  • Contains 65%-75% Tri-Calcium Phosphate and 25%-35% Hydroxyapatite
  • Company's portfolio includes stem cell technology

Sources: Releasable 510(k) database, company websites, press releases, information in the public domain

Product Labels: Spinal Fusion, Vertebroplasty/Kyphoplasty, Trauma Ankle/Foot/Toe, Lower Extremity

Tags: 510(k) Clearance, Regulatory