The current clearance covers the company’s mini-frag/small bone, long bone fracture, and ankle fracture/fusion plates
Tyber Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its expanded line of anatomical plating systems.
The company now provides a range of fixation devices for the extremities, as more than 1,500 SKUs are covered under the clearance.
Developed using a combination of CT scans, clinical data, cadaveric labs, and consultation with orthopaedic and podiatric surgeons, the line consists of more than 73 different indication-specific anatomical plating families.
Under the recent clearance, the mini-frag/small bone, long bone fracture, and ankle fracture/fusion plates are covered.
The company intends to introduce its new fixation systems in 2022. With the support of its global clinical registries to gather post market clinical follow-up (PMCF), it also intends to seek a CE mark for the new systems.
Tyber Medical CEO Jeff Tyber said: “Our second and largest FDA Clearance makes Tyber Medical a complete source for orthopedic plating for our partners and the surgeons they serve.
“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 mini-frag/small bone plates includes a series of stainless steel and titanium standard and variable locking compression plates and screws of varying lengths, thicknesses, and configurations.
The system enables to stabilise fractures, osteotomies, joint fusions, non-unions, and fusions of small bones and small bone fragments to the hand, wrist, foot, and ankle.
Its foot and ankle plating line is suitable for the fixation of medium/large bones, multi-fragment containment, in addition to reconstruction and revision surgeries.
The company’s long bone fracture plates include a straight, low-contact locking plate and a 1/3 locking tubular plate.
The plates includes hybrid cortical/cancellous thread featuring both variable angle locking and standard non-locking screws.
It is used for osteotomies and non-unions and the fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna and fibula.
With different locking plate types for various fibula and tibia positions, the ankle fracture/fusion system will help address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery.
The system is used for 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.
In addition, the titanium system consists of colour anodised for easy identification of sizing and alignment with colour-coded instrumentation.