Tyber Medical receives US FDA clearance on foot and ankle plating systems

▴ Tyber Medical receives US FDA clearance on foot and ankle plating systems
The comprehensive portfolio is the first of several planned plating releases for the distal extremities

Tyber Medical, LLC, a leading orthopaedic device manufacturer providing private label orthopaedic implants for the trauma, extremity, and spine markets, received a U.S. Food and Drug Administration (FDA) 501(k) clearance for its new line of foot and ankle plating systems. The FDA clearance covers over 42 different indication-specific anatomical plating families, extensively developed using a combination of CT scans, cadaveric labs, and consultation with surgical thought leaders.

Tyber Medical's plating systems are indicated to treat a comprehensive range of deformity, trauma, and degenerative conditions to the forefoot, midfoot, rearfoot, and ankle. Tyber Medical plans to launch the first phase of plates in the first half of 2021 and is actively pursuing the CE Mark in the second half of 2021.

Tyber Medical's Foot and Ankle Plating Systems feature a 30-degree, multi-angle, locking mechanism optimized for superior stability between the plate and screws. An intuitive, modular, tray delivery system is customizable with a colour-coded, clean layout that is consistent with the surgical flow to meet surgeons' instrumentation needs. The systems include low profile (1.3mm) plates to minimize soft tissue irritation while maximizing the variable locking technology to reduce screw head prominence. Additionally, the sterile and non-sterile plates include an engineered combination of material and surface modification which significantly increases fatigue resistance. "Our system is designed to minimize soft tissue trauma during the procedure," said Melissa Coale, Tyber Medical senior engineer.

"Our plates feature geometry to reduce overall prominence, especially in areas with minimal soft tissue coverage."

"We are excited to receive the FDA clearance that officially launches Tyber Medical into the orthopaedic plating arena," said Tyber Medical CEO and President, Jeff Tyber. "Our team has developed a robust method linking intrinsic design and ease of use for a variety of surgical indications. We expect to expand this methodology beyond the lower extremities and into all areas of the skeletal anatomy."

Tyber Medical's plating systems for fore-, mid-, hindfoot, ankle repair, and ankle fusion are indicated for use in the fixation of phalanges, metatarsals, and small bone fragments in the forefoot, and medium-to-large bones and multi-fragments in the mid- and hindfoot. Forty-two different indicated plates stabilize fractures, joint fusions, osteotomies, nonunions, malunions, reconstruction of small bones, revision surgeries, and re-plantations to facilitate successful healing in adult patients. The company's Ankle Fracture System is indicated for use in the fixation of fractures of the distal tibia, intra- and extra-articular, and medial malleolar fractures.

Tyber Medical is committed to developing rapid access, innovative, orthopaedic device technology to advance patient care and healing outcomes. The company's extensive medical device portfolio effectively supports gaps in its partners' product offerings in as little as four months though vertically-integrated design, engineering, manufacturing, quality management, regulatory, clinical research, and MDR compliance.

Tags : #TyberMedical #LatestNewsonTyberMedical21stOct #LatestPharmaNews21stOct #USFDA #LatestUSFDAClearanceNews21stOct #JeffTyber #MelissaCoale #AnkleFractureSystem #Deformity

About the Author

Team Medicircle

Related Stories

Loading Please wait...

Trending Now

PM addresses the Nation today, announces free vaccinesJune 07, 2021
Why inhalers are best for treating asthma, well illustrated by Dr. Anil SingalMay 12, 2021
Dr. Rohan Palshetkar shares his invaluable insights about the Maternal Mortality Rate causes and improvements in India April 29, 2021
It is important to adopt a non-judgmental attitude towards any teenage girl seeking contraceptive advise suggests Dr. Teena Trivedi, Obstetrician and GynecologistApril 16, 2021
80% of the diseases are psychosomatic which means they have roots in the mind and this is where homeopathy steps in - It resolves physical ailments by finding the cause in the mind – Dr. Sanket Dhuri, Consultant Homeopath April 14, 2021
A futuristic Vision of a Healthcare Entrepreneur: Shyatto Raha, CEO, and Founder of MyHealthcareApril 12, 2021
Saher Mehdi, Founder and Chief Scientist at wellOwise talks about aspects making healthcare more equitable and reachableApril 10, 2021
Wide variety of therapies to address autism in children explained by Dr. Shilpa Jasubhai, Clinical PsychologistApril 09, 2021
Allopathic and Homeopathic medicines should not be taken together says Dr. Sunil Mehra, Homeopath ConsultantApril 08, 2021
The charm of homeopathic medicine is that it can be taken with conventional medicines – Dr. Shruthi Shridhar, Consulting Homeopath April 08, 2021
Dissociative Identity Disorder and associated concepts explained by Dr. Vinod Kumar, Psychiatrist and Head of Mpower - The Centre (Bangalore) April 07, 2021
Dissociative Identity Disorder explained by Dr. Shilpa Jasubhai, Clinical PsychologistApril 05, 2021
Sehat Ki Baat, Karishma Ke Saath- Episode 6 Healthy Diet For Boosting Metabolism Which Can Help Thyroid Patients April 03, 2021
Significant Pointers on Kidney Health by Dr. Santosh Waigankar, Consultant Urooncologist and Robotic Surgeon at Kokilaben Dhirubhai Ambani HospitalApril 01, 2021
Dr. Vaishal Kenia, Ophthalmologist Talks About the Different Possibilities Available for the Treatment of Glaucoma Depending Upon Their Type and SeverityMarch 30, 2021
No Definitive Role of Diet in Treatment of Lymphedema but Intake of Calories, Salt and Long Chain Fatty Acids should be controlled says Dr. Ramani CVMarch 30, 2021
Dr. Kiran Chandra Patro, Senior Nephrologist Talks About Dialysis as the Temporary Process and Not a Permanent Cure for the Patients of Renal DysfunctionMarch 30, 2021
Two out of three new chronic kidney disease patients are found to have diabetes or hypertension informs Dr. Sreeharsha HarinathaMarch 30, 2021
Glaucoma Treatment: Medications or Surgery? A valuable piece of advice from Dr. Pranay Kapdia, Chairman and Medical Director of Kapadia Eye CareMarch 25, 2021
Dr. Shraddha Satav, Consultant Ophthalmologist Recommends that Everybody After 40, Should Go for the Complete Eye Checkup at Regular IntervalMarch 25, 2021