Arthrodesis

OSSIO’s Groundbreaking Option for Fixing Bone Fractures In Children Receives FDA Clearance

Retrieved on: 
Wednesday, December 6, 2023

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231206064383/en/
    The FDA has cleared the company’s OSSIOfiber® bio-integrative fixation technology for use in orthopedic surgery for children and adolescents needing bone fractures fixed, osteotomies, or fusions.
  • As a result, OSSIOfiber Compression Screws and Trimmable Fixation Nails may now be used in children from age two to 21 years in standard clinical practice.
  • Designed for rapid bone in-growth, regeneration and replacement, OSSIOfiber Intelligent Bone Regeneration Technology is a first-of-its-kind implant material stronger than cortical bone.
  • It can address many surgical applications through the manufacturing of endless implant designs, including nails, screws, staples, anchors and plates.

Spinal Simplicity Announces 510(K) FDA Clearance of Its Novel Sacroiliac Joint System, the Liberty-SI Lateral Implant

Retrieved on: 
Monday, December 11, 2023

OVERLAND PARK, Kan., Dec. 11, 2023 /PRNewswire-PRWeb/ -- Today, Spinal Simplicity is pleased to announce the U.S. Food & Drug Administration (FDA) 510(K) clearance of the Spinal Simplicity Liberty-SI Lateral Implant System; a transfixing, lateral sacroiliac (SI) joint fusion system. The Liberty-SI Lateral Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac disruptions and degenerative sacroiliitis.

Key Points: 
  • Spinal Simplicity's Liberty-SI Lateral Implant System is a revolutionary sacroiliac joint fusion technology designed for safer and potentially less invasive treatment of sacroiliac disruptions and degenerative sacroiliitis.
  • OVERLAND PARK, Kan., Dec. 11, 2023 /PRNewswire-PRWeb/ -- Today, Spinal Simplicity is pleased to announce the U.S. Food & Drug Administration (FDA) 510(K) clearance of the Spinal Simplicity Liberty-SI Lateral Implant System ; a transfixing, lateral sacroiliac (SI) joint fusion system.
  • The Liberty-SI Lateral Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac disruptions and degenerative sacroiliitis.
  • The lateral surgical technique first decorticates the bone, preparing the joint for fusion.The Liberty-SI implant is designed to achieve arthrodesis of the SI joint using a lateral technique that passes through the ilium across the sacroiliac joint and into the sacrum, thus transfixing the sacroiliac joint.

AMA Introduces New Category I CPT Code 27278 for Posterior SI Joint Fusion

Retrieved on: 
Tuesday, October 17, 2023

TAMPA, Fla., Oct. 17, 2023 /PRNewswire/ -- The American Medical Association (AMA) has announced the release of the 2024 CPT code set, which includes a new Category I CPT code for PainTEQ's LinQ SI Joint Stabilization procedure. The new code, effective as of January 1, 2024, is 27278.

Key Points: 
  • TAMPA, Fla., Oct. 17, 2023 /PRNewswire/ -- The American Medical Association (AMA) has announced the release of the 2024 CPT code set, which includes a new Category I CPT code for PainTEQ 's LinQ SI Joint Stabilization procedure.
  • The detailed description of the new code is:
    27278 Arthrodesis, sacroiliac joint, percutaneous, with image guidance, including placement of intra-articular implant(s) (e.g.
  • Michael Mydra, Senior Vice President, Reimbursement and Market Access at PainTEQ, expressed his enthusiasm about the new code, stating, "The inclusion of the LinQ SI Joint Stabilization procedure as a Category I CPT code is a major milestone for PainTEQ, physicians performing the procedure, and patients suffering from SI Joint pain.
  • The assignment of this new CPT code is a testament to the efficacy and importance of the LinQ procedure.

SAIL Fusion Announces First Implantations of its BowTie™ Sacroiliac Fusion System

Retrieved on: 
Monday, October 16, 2023

SAIL Fusion, a medical device company focused on advancing the surgical treatment of sacroiliac joint dysfunction through solutions built upon AO principles, today announced that it has conducted the first implantations of its novel BowTie SI Fusion System.

Key Points: 
  • SAIL Fusion, a medical device company focused on advancing the surgical treatment of sacroiliac joint dysfunction through solutions built upon AO principles, today announced that it has conducted the first implantations of its novel BowTie SI Fusion System.
  • BowTie is the first SI fusion system to be based on long-standing, proven joint fusion principles established by the AO foundation.
  • I fully expect these patients to do extremely well.”
    Dr. Karimov added, “The BowTie System allowed me to fully access the joint and create an ideal environment for fusion.
  • We look forward to completing our pilot study and launching the product in the United States in the near future.”

Xēnix Medical neoWave™ Interbody Systems Receive FDA Clearance for NANOACTIV™ Nanotechnology Surface

Retrieved on: 
Tuesday, October 10, 2023

The NANOACTIV implant surface demonstrates elements to be considered a nanotechnology as outlined in FDA nanotechnology guidance document.

Key Points: 
  • The NANOACTIV implant surface demonstrates elements to be considered a nanotechnology as outlined in FDA nanotechnology guidance document.
  • Ryan Phillips, President of Xēnix Medical, commented, “Receiving nanotechnology clearance for the neoWave interbody systems is an incredible milestone and achievement for Xēnix, elevating the neoWave implant systems into a distinct device category shared only by a few companies in the industry.
  • As we actively develop a complete line of neoWave interbody devices, the NANOACTIV surface will be a dominant enhancement of future implant systems.
  • The unique combination of a nanotechnology surface and completely latticed implant presents a significant breakthrough in treating patients that require interbody fusion.

OSSIO Launches World’s First and Only Non-Permanent Compression Staple

Retrieved on: 
Tuesday, February 7, 2023

OSSIO , Inc., a fast-growing orthopedic fixation technology company, today announced the introduction of the new OSSIOfiber® Compression Staple, the next step towards becoming the gold standard in orthopedic fixation.

Key Points: 
  • OSSIO , Inc., a fast-growing orthopedic fixation technology company, today announced the introduction of the new OSSIOfiber® Compression Staple, the next step towards becoming the gold standard in orthopedic fixation.
  • OSSIO’s fifth product family, OSSIOfiber® Compression Staples, allow surgeons to evolve to stronger, bio-integrative compression.
  • OSSIOfiber® Compression Staples provide excellent stability and fixation, are stronger than many nitinol staples, and offer superior compression performance versus many widely used compression staples.
  • “I used the staple for compression of a first MTP instead of a plate and it was fantastic,” said Dr. Parekh.

Arugula Sciences announces FDA Approval to Proceed with Phase 1 Study of SIG002, a Perinatal-derived Secretome Product, for the Treatment of Big Toe Osteoarthritis (Hallux Rigidus)

Retrieved on: 
Tuesday, January 31, 2023

This trial will assess the safety, tolerability, preliminary efficacy, and dose effect of SIG002 in patients with symptomatic osteoarthritis of the first metatarsophalangeal joint.

Key Points: 
  • This trial will assess the safety, tolerability, preliminary efficacy, and dose effect of SIG002 in patients with symptomatic osteoarthritis of the first metatarsophalangeal joint.
  • “This is the second FDA approval of a Phase 1 clinical IND for the company,” says Ramon Coronado, Ph.D., Chief Scientific Officer.
  • Hallux Rigidus (HR) is osteoarthritis of the joint in the big toe – one of the most common disorders of this joint.
  • Arugula Sciences has developed a novel patent-pending, room temperature stable, perinatal-derived product (SIG002) consisting of a purified secretome free of tissue fragments and cells.

Medline to launch UNITE Ankle Fusion Plating System at ACFAS 2023 Annual Scientific Conference

Retrieved on: 
Thursday, February 9, 2023

NORTHFIELD, Ill., Feb. 9, 2023 /PRNewswire/ -- Attendees at this year's American College of Foot and Ankle Surgeons (ACFAS) Annual Scientific Conference in Los Angeles, California, will be among the first to see the UNITE Ankle Fusion Plating System. This new product is the company's seventh indication-specific titanium plating system since launching in 2015.

Key Points: 
  • NORTHFIELD, Ill., Feb. 9, 2023 /PRNewswire/ -- Attendees at this year's American College of Foot and Ankle Surgeons (ACFAS) Annual Scientific Conference in Los Angeles, California, will be among the first to see the UNITE Ankle Fusion Plating System .
  • "The Ankle Fusion system bolsters an already robust implant offering and allows us to now address every foot and ankle procedure requiring indication-specific plating," said Scott Goldstein, director of marketing at Medline UNITE Foot & Ankle.
  • The UNITE Ankle Fusion Plating System is indicated for use in arthrodesis of the ankle, including tibiotalar (TT), tibiotalocalcaneal (TTC) and tibiocalcaneal (TC) fusions.
  • "The UNITE Ankle Fusion Plating System is designed with everyone in mind, from the patient to the surgeon to the staff," said Dr. R. James Toussaint, MD of Gainesville, FL.

Global Ankle Fusion Plates Market Forecast and Opportunities to 2027: Increasing Geriatric Populations with Bone-Related Ailments Influencing Growth - ResearchAndMarkets.com

Retrieved on: 
Tuesday, December 13, 2022

The global ankle fusion plates market is anticipated to register growth at an impressive CAGR in the forecast period, 2023-2027

Key Points: 
  • The global ankle fusion plates market is anticipated to register growth at an impressive CAGR in the forecast period, 2023-2027
    The market growth can be attributed to the growing prevalence of arthritis across the globe.
  • Moreover, the rising geriatric population more prone to osteoporosis and other bone-related ailments is adding to the market growth.
  • Ankle fusion plates refer to implants placed inside the body to repair or reconstruct the damaged or injured part of the ankle.
  • Company Profiles: Detailed analysis of the major companies present in global ankle fusion plates Market.

Interbody Fusion Cage Global Market Report 2022: Worldwide Increases in Spinal Cord Injuries Driving Growth - ResearchAndMarkets.com

Retrieved on: 
Friday, October 21, 2022

Interbody fusion cage is an artificial medical device, which is utilized in spinal fusion procedures to maintain foraminal height and decompression.

Key Points: 
  • Interbody fusion cage is an artificial medical device, which is utilized in spinal fusion procedures to maintain foraminal height and decompression.
  • The interbody fusion cage is a large, hollow cylinder made up of metals such as titanium, carbon fiber, or allograft femur.
  • However, high cost associated with spinal fusion surgeries and dearth of skilled professionals are anticipated to impede the growth of interbody fusion cage market.
  • By product type, the market is segregated into lumbar cage, cervical cage, thoraco-lumbar cage, and thoracic cage.