FDA 510(k) Recap: First Orthopedic Clearances

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This month’s recap informs you of companies entering the major orthopedic market segments with their first product clearance. The six companies we chose to highlight received their clearance within the last quarter of 2020. Geographically, they span the U.S., Australia and Italy.

Joint Replacement

Accufix Surgical | Accu-Joint Hemi Implant, K200951

  • Submitted April 2020, granted December 2020
  • Primary predicate: Vilex in Tennessee Cannulated Hemi Implant, K190543, K102401, K070052, K023684
  • Articular joint replacement system designed to treat patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock, along with the following clinical conditions: Hallux Limitus, Hallux Valgus, Hallux Rigidus and an unstable or painful MTP joint
  • Intended for use with bone cement
  • About the company:
    • Established in 2016, based in West Haven, Connecticut
    • Formed to develop this rigidly fixated (ORIF), non-weight bearing joint implant that does not resect bone

Ensemble Orthopedics | Ensemble CMC Wrist Prostheses, K201072 (pictured above)

  • Submitted April 2020, granted December 2020
  • Primary predicates: Ascension PyroSphere, K042690; Ascension CMC, K061451; Extremity Medical Trapezium, K092548; Skeletal Dynamics Stablyx CMC Arthroplasty, K111068; Wright Medical Tie-In Trapezium, K033529
  • Uncemented, one-piece joint prosthesis designed to fit in the space between the trapezium and first metacarpal for patients with early stage arthritis
  • Proprietary saddle shape that replaces the natural bearing surfaces of the carpal and metacarpal bones with an interpositional implant
  • Manufactured from On-X Carbon (pyrocarbon), a biocompatible, low modulus and durable material that has been shown to cause less bone wear vs. metal or ceramic implants
  • About the company:
    • Established in 2020, based in West Lake Hills, Texas
    • Developing additional products for wrist and finger joints
    • Leadership brings experience from Ascension Orthopedics, Biomet, Encore Orthopedics, Gelifex, HydroCision, Johnson & Johnson, Nexgen Spine

Navbit | Navbit Sprint System for Lateral and Supine Registration in Hip Replacement, K200376

  • Submitted February 2020, granted December 2020
  • Primary predicate: OrthAlign Plus System, K172462
  • Computer-controlled disposable, single-use surgical navigation system to support accurate positioning of the acetabular cup and lower the risk of dislocation following hip replacement
  • Also approved by the Australian Therapeutic Goods Administration and European Commission (CE Mark)
  • About the company:
    • Established in 2016, based in Crows Nest, New South Wales, Australia
    • Partnered with DePuy Synthes for Navbit Sprint distribution
    • In late 2018, received a minority investment from Parvizi Surgical Innovations which supports growth of new technologies through research and development

Spine

Advanced Medical Systems | Resascope RS-01/B, K201113

  • Submitted April 2020, granted December 2020
  • Primary predicate: Myelotec Video Guided Catheter, K980734
  • Can be used in the lumbar and sacral epidural space to view the epidural anatomy, the pathology and to deliver approved drugs for epidural administration
  • Allows physician to light and view the tissues in the epidural space of the lumbar and sacral spine, and assist in the diagnosis of related pathologies, using a percutaneous approach through the sacral hiatus
  • Features a soft tip and blocks inside the handle that allow the catheter to remain locked and oriented without return to zero
  • 3 options for optic and tools insertion, manufactured on the handle itself to reduce encumbrance on the operating field
  • Launched ex-U.S. in 2015
  • About the company:
    • Established in 1998, based in San Pietro Viminario, Italy
    • Has also developed spinal stabilization technologies: axial rods for lumbosacral fusion and an interbody cage

Carlsmed | aprevo Intervertebral Body Fusion Device, K202034

  • Submitted July 2020, granted December 2020
  • Primary predicate: Globus Medical HEDRON Lumbar Spacers, K191391
  • Patient-specific 3D-printed titanium interbody devices for the correction of adult spinal deformity
  • Reportedly the first implant ever to receive both Breakthrough Device Designation and 510(k) market clearance from FDA
  • Only spinal device to qualify for the Alternative Inpatient New Technology Add-On Payment (NTAP) Pathway for Transformative New Devices that was enacted by CMS
  • About the company:
    • Established in 2018, based in Carlsbad, California
    • Closed a $10 million Series A financing to commercialize a digital + surgical planning solution and aprevo implants
    • Leadership brings experience from Alphatec, DePuy Synthes Spine, Ellipse Technologies, em-cor, Innovasis, MacroPore Biosugery, Medtronic, N Spine, NuVasive, Orchid Orthopedic Solutions, Tissue Regeneration Systems, X-Spine, Zimmer Biomet Dental

Sports Medicine

Acuitive Technologies | CITREGEN Tendon Interference Screw and CITRELOCK, K200725

  • Submitted March 2020, granted October 2020
  • Primary predicate: Arthrex Tenodesis Family, K051726
  • CITREGEN material is a new-generation FDA-cleared thermoset bioresorbable synthetic polymer
  • CITREGEN is designed to replicate the intrinsic cellular biochemical and structural support network; its main component, citrate, is a naturally occurring anti-microbial and anti-inflammatory molecule that regulates cellular metabolic processes and the formation of mineral structures
  • CITREGEN leaves behind a biomimetic ceramic structure to be metabolized by host tissue; bioresorption avoids the potential for bulk degradation and chronic inflammation as opposed to current biodegradable polymers
  • CITRELOCK is indicated for fixation of ligaments or tendon graft tissue repairs of the shoulder, elbow, wrist, hand, knee, ankle and foot
  • Will be offered with both reusable or single-use instruments, in a full range of device sizes; product launch is slated for early 2021
  • About the company:
    • Established in 2013, based in Allendale, New Jersey
    • Leadership brings experience at Accellent, Biomet, Howmedica, Implex, Pipeline Orthopedics, Stryker Mako, Stryker Orthopaedics, Stryker Osteonics, Tyber Medical, Zimmer

JAV

Julie A. Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

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