Trauma and Spine Gain New Players with First 510(k)s in 1H17

In 1H17, 23 orthopaedic companies from 11 countries received their first 510(k), according to our scan of FDA’s database. Nine of the 23 510(k)s were in trauma and seven in spine.

Many of the ex-U.S.-based companies receiving trauma and spine clearances have full portfolios in their respective market segments. Backed by 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. orthopaedic market. We call your attention to these companies to assist you in identifying new technologies, startups and ex-U.S. companies entering the U.S. market.

A list of new 510(k)s across all segments follows and provides details on company, location, background and technology.

Aju Pharm
ajupharm.co.kr | 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
akrosmedical.com | 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
amplitude-ortho.com | 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)

Bodycad
bodycad.com | 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
en.cnmi.cc | 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
gramercyortho.com | 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
greensurgical.com | 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
surgicalfrontiers.com | 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, will focus on less invasive intramedullary fracture fixation of clavicle, radius, ulna and fibula

OsteoNovus
osteonovus.com | 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

Phamedica
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
radicleortho.com | 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
sicage.com | 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
silony-medical.com | 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
sagico.eu | 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
summitspineco.com | 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

Wemed Bio-Tech
wemed-biotech.com | 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
wittenstein.de | 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
  • Portfolio includes custom-made lengthening systems

XpandOrtho
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