The largest 510(k) FDA clearance in history.
That's the claim Tyber Medical, LLC makes regarding the August 13, 2021, FDA clearance of the company's expanded line of anatomical plating systems. The expansion covers all long and short bones.
The clearance, according to the company, has more than 1,500 SKUs (stock keeping units), including over 73 different indication-specific anatomical plating families. The systems were developed using CT scans, clinical data, cadaveric labs, and consultations with orthopedic and podiatric surgeons.
The indication categories for this clearance include Mini-frag/Small Bone, Long Bone Fracture, and Ankle Fracture/Fusion plates.
The Mini-frag/Small Bone plates, according to the company, incorporate a series of stainless steel and titanium standard and variable locking compression plates and screws of varying lengths, thicknesses, and configurations.
These plates and screws address 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.
The Long Bone Fracture plates consist of a straight, low-contact locking plate and a 1/3 locking tubular plate. The company says the plates incorporate hybrid cortical/cancellous thread featuring both variable angle locking and standard non-locking screws.
The plates are intended for osteotomies and non-unions and the fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, and fibula.
The Ankle Fracture/Fusion System, according to the company, 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 specifics of all the cleared indications are available on the FDA web site.
"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.
Company CEO Jeff Tyber said, "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."
Since its founding in 2012, the private labeler original equipment manufacturer (OEM) orthopedic implant maker has released more than 50 extremity/trauma/spine systems. The company says all its products have FDA and CE regulatory clearance. The systems are fully designed, tested, verified, and validated using Tyber Medical’s ISO 13485:2016, EC Certificate and MDASP for the CE Marked Interbody Spacers, and FDA QSR compliant quality system.
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