10 Spine Companies Receive Their First FDA 510(k)

Thus far in 2020, ten companies received their FDA 510(k) clearances that were not only firsts for the company, but also obtained for a spine product.

The ten are a good blend of geographic regions, representing Australia, China, England, France, Germany, India, Taiwan and the U.S.

Axis Spine Technologies | Axis Spine Technologies ALIF, K200352

• Submitted February 2020, granted May 2020
• Primary predicate: Custom Spine Optimus ALIF System (K132596)
• Used to treat degenerative disc disease at one or two contiguous levels from L2 to S1, with supplemental fixation and bone graft
• About the company:
  o Founded in 2017, based in St. Albans, Hertfordshire, England
  o Developed a platform technology of build-in situ modular cages as an alternative to conventional cage designs
  o Modular endplates are inserted in a closed position, atraumatically helping to preserve the structural integrity of the vertebral endplate
  o Received £830,000 (~USD $1.0 million) in new funding in 2Q20 to bring products to the spine market, with an initial focus on the U.S.
  o Leadership brings experience from ApaTech, DePuy International, NuVasive

Hyprevention | V-STRUT Vertebral Implant, K191709

• Submitted June 2019, granted March 2020
• Primary predicate: Benvenue Medical KIVA VCF Treatment System (K132817)
• Indicated for the treatment of vertebral fractures in the thoracic and lumbar spine due to osteoporosis or tumorous bone lesions
• Intended for use with Teknimed F20 bone cement
• Part of the V-STRUT Transpedicular Vertebral System, comprising V-STRUT Vertebral Implant, Guide Wire and Instrumentation Kit
• Features a pedicle anchorage designed to distribute vertebral load between anterior and posterior columns to reduce subsequent and adjacent fractures
• Adapts to bone stiffness and is combined with PMMA bone cement for fracture fixation, implanted in a minimally invasive procedure
• About the company:
  o Founded in Pessac, France in 2010
  o Has also developed the Y-STRUT (not FDA cleared) for internal fixation of the proximal femur in patients at risk of osteoporotic fracture and for impeding pathological fracture; Y-STRUT is approved for use in Brazil and Israel, and is the subject of clinical trial for application in traumatology
  o Leadership brings experience from Integra LifeSciences, Scient’x, Stryker Spine, Vexim

Ilion Medical | NADIA Sacroiliac Joint Fusion System, K190580

• Submitted March 2019, granted August 2020
• Primary predicate: Tenon Medical, Catamaran (K180818)
• NADIA stands for Neurovascular Anticipating Distraction Interference Arthrodesis
• Features the NADIA NeuroSafe posterior bridging approach to eliminate neurovascular risks commonly associated with laterally based techniques
• Titanium plasma spray and hydroxyapatite coating to engage the bone at microscopic and macroscopic levels
• Pin-guided instrumentation for consistent implant placement
• Revisability is built into the implant design; a larger size can be placed in the same location with the same familiar approach if revision is necessary
• About the company:
  o Surgeon-founded in 2008 in Minneapolis, Minnesota

Indius Medical Technologies | SEA-LINK Anterior Cervical Plate System, K200224

• Submitted January 2020, granted March 2020
• Primary predicate: Globus Medical Providence Anterior Cervical Plate System (K070775)
• Features a large mediolateral window for graft visualization, a cam-based locking mechanism to ensure positive locking and prevent screw back out, and Torx based screws to prevent stripping
• Instrument set is designed to facilitate efficient workflow during surgery
• About the company:
  o Founded in 2016 in Pune, India
  o Other products include cervical and lumbar interbody spacers, lumbar pedicle screw and a corpectomy spacer
  o Focused on development of solutions to treat pediatric spinal deformities
  o Founder and CEO was formerly Director of Product Development at Globus Medical, while another director brings experience from Globus Medical, Stryker Spine and Synthes

Joline | Joline Kyphoplasty System Allevo, K192449

•  Submitted September 2019, granted May 2020
• Primary predicate: Osseon Osseoflex SB (K150607)
• For reduction and fixation of fractures or creation of a void in cancellous bone in the spine during balloon kyphoplasty, with PMMA bone cement
• Includes both single and double balloon catheter options that allow the introduction of one or two balloons into each pedicle at a time, for a total of two or four balloons per vertebrae
• Allevo kit combinations are available for mono and double balloons, as well as a Basic/Economy kit (just the essentials and the Smart/Standard kit (does not include cement)
• About the company:
  o Founded over 15 years ago; based in Hechingen, Germany
  o Also provides dialysis catheters and stents

Orion Biotech | ORION Pedicle Screw Spinal System, K190600

• Submitted March 2019, granted August 2020
• Primary predicate: Baui Biotech Facilis Spinal System (K161231)
• Titanium and PEEK screws, rods, links and accessory connection components for posterior thoracolumbar fusion
• Company is located in Taipei, Taiwan

OrthoCircle Spine | OrthoCircle Spine Pedicle Screw System, K193472

• Submitted December 2019, granted February 2020
• Primary predicate: Medacta M.U.S.T. Pedicle Screw System (K171170)
• Titanium alloy device implanted from the posterior approach, comprising rods, poly-axial screws and set screws
• Implants provided sterile in individual packaging; instruments provided as non-sterile and require sterilization prior to use
• About the company:
  o Founded in 2011 in Savannah, Georgia
  o Sole U.S.-based distributor of Komet Medical products, offering German-made cutting and fixation instruments that are compatible with common power systems such as Aesculap, Arthrex, Stryker, Zimmer Biomet, etc.
  o OrthoCircle is classified as specification developer for the pedicle screw system K193472, as an entity that develops a specification for a device that is distributed under that company’s name, although it performs no manufacturing
  o OrthoCircle leadership brings experience from Brasseler, Covidien, KLS Martin, Smith+Nephew, Stryker

Prism Surgical Design | Aurora Anterior Lumbar Plate System, K201079

• Submitted April 2020, granted August 2020
• Primary predicate: DePuy Spine, AEGIS Anterior Lumbar Plate (K052546)
• Indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion
• Inclusive of the SouthPole® Alignment and Fixation System, protected by patents in the U.S., U.K. and Australia
• About the company:
  o Founded in 2011 in Queensland, Australia
  o Recently received approval under the CE Mark
  o Leadership brings experience from DePuy Spine

Shangdong Kangsheng Medical Devices | Spinal Fixation System, K190408

• Submitted February 2019, granted June 2020
• Primary predicate: Weigao Orthopaedic Device, Intramedullary Nail (K122994)
• Spinal Fixation System is intended for posterior, non-cervical, pedicle fixation
• About the company:
  o Founded in 2010 in Shandong, China
  o Leadership brings experience from Canwell Medical

Spinal Stability | MODULIF-A Anterior Lumbar Interbody Fusion System, K200958

• Submitted April 2020, granted August 2020
• Primary predicate: Zimmer Spine InFix Anterior Lumbar System (K132790)
• Modular interbody fusion case for lumbar degenerative disc disease
• About the company:
  o Founded in 2008 in Austin, Texas
  o In 2008, closed $200,000 of a $1 million offering
  o President brings experience from Abbot Spine, Encore Medical and Zimmer, as well as own consulting company that assists orthopedic companies with the product development of new projects

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