FDA 510(k) Recap: First Clearances in 2020

The following five companies are among the 23 that received their first FDA 510(k) clearances to date in 2020. They aren’t new—in fact, most of them have been around for at least a decade. Three are headquartered outside of the U.S. These clearances mark their entrance into the U.S. market.

Joint Replacement

BRM Extremities | NewPrim Polymer Toe Implant System, K191966

• Submitted July 2019, granted February 2020
• Primary predicate: In2Bones RTS Flexible 1 MPJ Implant w/Grommets (K153609)
• Indicated to treat hallux rigidus/limitus, rheumatoid arthritis, etc.
• Double-stemmed, constrained, silicone prosthesis, intended to replace the osteo-cartilaginous heads of the first metatarsophalangeal joint
• Acts as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx
• About the company:
  o Founded in 2011
  o Headquartered in Italy, with locations in the U.K. and U.S.
  o Other non-FDA-cleared products for the forefoot, midfoot and hindfoot include the Silktoe toe joint replacement, Kirschner wires and burrs

Optimotion Implants | Optimotion Blue Total Knee, K191084

• Submitted April 2019, granted April 2020
• Primary predicates: Consensus Orthopedics PS2 Knee (K160515), Stryker Triathlon Tritanium Tibial Baseplates (K123486), Stryker Triathlon Total Knee (K051380)
• Indicated for total and revision procedures, cemented or uncemented
• Optimized for ambulatory care centers
• About the company:
  o Founded in Florida in 2016
  o Surgeon-founded; associate has experience at Lincotek Medical and Wright Medical

Spine

Hyprevention | V-STRUT Vertebral Implant, K191709 (Pictured)

• 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 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

Sports Medicine

CoNextions Medical | Coronet Soft Tissue Fixation System, K200028

• Submitted January 2020, granted March 2020
• Primary predicate: Ziptek ZipE Knotless Tissue Repair and Attachment Devices (K162429)
• Intended for various applications throughout the anatomy: shoulder, elbow, hand/wrist, knee, foot/ankle
• Single-use, sterile stainless steel, and ultra-high molecular weight polyethylene implant comprising an anchor and soft tissue washer, connected via a continuous loop of suture, pre-assembled to an inserter
• Drill bit allows for creation of a properly sized pilot hole in the bone implantation site
• Designed to improve the soft tissue fixation strength of repairs vs. use of conventional sutures; delivery system allows for simultaneous placement of the implant in the bone and soft tissue with a knotless repair
• About the company:
  o Founded in Utah in 2011
  o Raised $10.4 million in five rounds between 2014 and 2018
  o Leadership brings experience from Amedica, Biomet, Centerpulse, Stryker Trauma & Extremities

Orthobiologics

Sirakoss | Osteo3 ZP Putty, K193075

• Submitted November 2019, granted June 2020
• Primary predicate: Medtronic Sofamor Danek USA, MASTERGRAFT Strip and Putty (K140375)
• Entirely synthetic, nanoporous bone graft substitute comprising novel inorganic granules suspended in a fully synthetic resorbable carrier that can be used directly from the pack
• Indicated for filling bone voids or defects of the skeletal system (extremities, pelvis, posterolateral spine) that are not intrinsic to the stability of the bony structure
• Must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine
• Osteo3 Granules gained approval under the CE Mark in 2019
• About the company:
  o Founded in 2011 in the U.K., spun out of the University of Aberdeen
  o Raised $4.8 million in Series A funding in 2014
  o One of the principals helped form ApaTech, which was eventually acquired by Baxter International

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