CEO Nick Deeter says that 95% of children continue to receive adult orthopedic products that were never intended for them nor cleared by FDA for use in children. WishBone seeks to change the paradigm of pediatric orthopedics with its child-focused implants and sterile packaged disposable kits.
Results from a retrospective, multicenter study with Treace Medical's Lapiplasty® 3D Bunion Correction procedure revealed a 96.8% maintenance of 3-plane correction at 13.5-month follow-up with an early weight-bearing protocol.
The world of foot and ankle is vibrant and full of opportunity to solve real problems. Honesty in implant improvement must take place at the design stage. Foot and ankle has the trifecta of implants. Depending on the case, I need hardware, soft tissue reconstruction and a biologic enhancer. This is unique in orthopaedics, and the company that wins recognizes the problem to be solved in its totality and not just a piecemeal approach.
Study results indicate that use of Flower Orthopedics' FlowerCube implant and instrument system in first metatarsal phalangeal joint fusion at an ASC resulted in a 33% decrease in intraoperative time and $1,300 savings in reimbursement costs, while providing equivalent clinical outcomes.
In 1H17, 23 orthopaedic companies from 11 countries received their first 510(k), according to FDA. We call your attention to these companies to assist you with identifying startups, as well as ex-U.S. companies entering the U.S. market.
Centric Medical announced FDA 510(k) clearance of the TARSA-LINK™ Bunion Correction system, reported to be the first-to-market standalone opening base wedge to feature built-in fixation. Launch is slated for 4Q16.
Strategic orthopaedic-related 510(k)s issued in May 2016 include: Navio Indication for TKA (Blue Belt Technologies), Enza Zero-profile Anterior Interbody Fusion System (Camber Spine), CSR Shoulder System (Catalyst OrthoScience*), Stropp/Single Tunnel Repair of Plantar Plate (CrossRoads Extremity), Cervical Interbody Fusion System (Evolution Spine*), Flip Button Suture Anchor (First Ray), Neofuse HA Enhanced PLIF/TLIF (HT Medical*), HC Spinal System (Hung Chun Bio-S*)
Bio2 Technologies received FDA 510(k) clearance to market a fusion system for interphalangeal fusion, fracture repair and osteotomies of toes, fingers and other small bones. Limited product launch is slated for 2Q16.