It’s not often that we see a new total hip system cleared by the FDA.
But on September 21, 2018, Cedar Knolls, New Jersey-based, b-ONE Ortho Corp. reported that the FDA granted 510(k) clearance for the company’s cementless total hip system after a ten-month review.
“The b-ONE is a cementless total hip system which features coating technology and instrumentation intended to optimize patient fit for a modern patient demographic.”
“The system includes the Juveno bone-conserving femoral prosthesis and the b-ONE primary acetabular systems, which are compatible with the b-ONE 12/14 taper femoral heads.”
According to FDA documents, “the system is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage.”
“The system is comprised of femoral stems and mating femoral heads; acetabular shells and mating acetabular liners; and, optional 6.5mm acetabular screws. Acetabular Shell options include no-hole and multiple hole configurations.”
“The Tapered Wedge Stem, Acetabular Shells, and Acetabular Bone Screws are made from Ti-6Al-4V-ELI. Stem and shell coatings include CPTi Plasma Porous Spray with or without HA. Femoral heads are made from CoCr or Ceram Tec Biolox delta.” Acetabular Shell Liners are made from conventional UHMWPE and UHMWPE with Vitamin E” and “all system components are supplied sterile and are single use devices.”
Predicates
The company cited eight predicate and four reference devices in its FDA notification documents. Predicates included Stryker’s V40, Trident Acetabular Shells and Self-Tapping Acetabular Screw, the Accolade II Hip Stem, Biomet’s G7 Acetabular System and Zimmer’s Continuum Acetabular System.
“Some minor differences in design and technology exist between the subject and predicate devices, however applicable reference devices have been cited to support the conclusion that these differences do not raise any new questions of safety and effectiveness,” stated the company in FDA documents.
Mark Kester, Ph.D., the company’s chief scientific officer and designer of Stryker’s Triathlon, said the first U.S. surgery was, “quickly approaching.” He noted the company’s support of Richard Rothman, M.D., “a prolific designer and developer in the orthopedic industry.”
b-ONE said that it is planning for a limited launch of the system during the first half next year and full commercial release during the second half of next year.
The company, founded in 2015, “… recently raised $20 million in a Series A round of financing led by Eight Roads Ventures and F-Prime Capital Partners, with proceeds to be used to fund product portfolio growth and expansion into international markets.”
