Tyber Medical Receives Largest FDA 510(k) Clearance For Expanded Line Of Anatomical Plating Systems
Clearance marks expansion into fixation devices for all long and short bones
BETHLEHEM, Pa., Sept. 1, 2021 /PRNewswire/ -- Tyber Medical, LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, received its second and largest U.S. Food and Drug Administration (FDA) 510(k) clearance for its expanded line of anatomical plating systems. With more than 1,500 SKUs included in the clearance, Tyber Medical now offers its most comprehensive portfolio of fixation devices for the extremities. The line includes over 73 different indication-specific anatomical plating families, extensively developed using a combination of CT scans, clinical data, cadaveric labs, and consultation with industry-leading orthopedic and podiatric surgeons.
"Tyber Medical now offers a comprehensive plating solution that bridges different indications and proliferates throughout the entire body to address trauma and deformity to the long and short bones," said Melissa Coale, Tyber Medical Director of Research & Development.
"Our second and largest FDA Clearance makes Tyber Medical a complete source for orthopedic plating for our partners and the surgeons they serve," said Tyber Medical CEO Jeff Tyber. "It's been less than 12 months from our first FDA clearance, underscoring the speed at which we can utilize our clinical research to develop, test, and iterate to fill the gaps in our partners' product portfolios with innovative solutions that benefit patient outcomes."
The indication categories for this most recent clearance include Mini-frag/Small Bone, Long Bone Fracture, and Ankle Fracture/Fusion plates. Tyber Medical's Mini-frag/Small Bone plates incorporate a series of stainless steel and titanium standard and variable locking compression plates and screws of varying lengths, thicknesses, and configurations. This system addresses the stabilization of fractures, osteotomies, joint fusions, non-unions, and fusions of small bones and small bone fragments to the hand, wrist, foot, and ankle. The foot and ankle plating line are used in the fixation of medium/large bones, multi-fragment containment, as well as reconstruction and revision surgeries.
Tyber Medical's Long Bone Fracture plates consist of a straight, low-contact locking plate and a 1/3 locking tubular plate. These plates incorporate hybrid cortical/cancellous thread featuring both variable angle locking and standard non-locking screws. It is intended for osteotomies and non-unions and the fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna and fibula. The Tyber Medical Ankle Fracture/Fusion System is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery, with a variety of locking plate types for various fibula and tibia positions. Indications for this system include fixation of fractures of the distal tibia, including ankle fractures, intra-, and extra-articular fractures, osteotomies, medial malleolar fractures, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus; and In distal tibia/fibula long bones.
The titanium system features color anodized for easy identification of sizing and alignment with color-coded instrumentation. Tyber Medical plans to launch its new fixation systems in 2022, while actively pursuing a CE Mark, utilizing the company's global clinical registries to collect Post Market Clinical Follow-up (PMCF).
Tyber Medical is committed to developing rapid access, innovative, orthopedic device technology to advance patient care and healing outcomes. The company's extensive medical device portfolio, which includes an extensive line of cannulated screw technology, effectively supports gaps in its partners' product offerings, in as little as four months, through vertically integrated design, engineering, manufacturing, quality management, regulatory, clinical research, and MDR compliance.
About Tyber Medical, LLC Tyber Medical, LLC, is a leading orthopedic device manufacturer providing rapid access to FDA-cleared and CE-marked private label, portfolio-enhancing, regulatory-approved orthopedic implants for the spinal interbody space and extremity/trauma markets. Tyber Medical provides customers with a quick and seamless path to market. Since it was founded in 2012, the company has released more than 50 extremity/trauma/spine systems. Tyber Medical aims to develop and utilize differentiated, bioengineered technologies, including different surface treatments and coatings, to make advanced, orthopedic implants.
Contact: Eric Dickson, Tyber Medical
Phone: 610-849-1710
Email: edickson@tybermed.com
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SOURCE Tyber Medical, LLC