Osteotomy

Paragon 28 Launches PRECISION® MIS Bunion System Offering Surgeons a Guided Minimally Invasive Surgical Solution for Treating Patients with Bunions

Retrieved on: 
Thursday, February 1, 2024

Paragon 28, Inc. (NYSE: FNA) is pleased to announce the launch of the PRECISION® MIS Bunion System, which allows surgeons to complete a distal metatarsal osteotomy using a minimally invasive (MIS) surgical technique.

Key Points: 
  • Paragon 28, Inc. (NYSE: FNA) is pleased to announce the launch of the PRECISION® MIS Bunion System, which allows surgeons to complete a distal metatarsal osteotomy using a minimally invasive (MIS) surgical technique.
  • The PRECISION® MIS Bunion System includes cannulated chamfer screws for fixation that allow alignment of the metatarsal head near the cortex of the first metatarsal.
  • Surgeon designer David Gordon, MD, commented, “The PRECISION® MIS Bunion System by Paragon 28 really changes the landscape of minimally invasive hallux valgus correction, using a distal osteotomy.
  • With this comprehensive portfolio, Paragon 28® provides its customers with a single source to address their bunion needs.

Paragon 28 Launches JAWS™ Great White Staple System Further Expanding its Nitinol Staple Offering

Retrieved on: 
Tuesday, November 14, 2023

Paragon 28, Inc. (NYSE: FNA) is pleased to announce the launch of its JAWS™ Great White Staple System which was developed to provide for increased strength and stability of the osteotomy or fusion site when compared to traditional staple systems.

Key Points: 
  • Paragon 28, Inc. (NYSE: FNA) is pleased to announce the launch of its JAWS™ Great White Staple System which was developed to provide for increased strength and stability of the osteotomy or fusion site when compared to traditional staple systems.
  • Our development team has designed implants which provide for greater fatigue resistance and increased compression when compared to market leading nitinol staple systems.
  • We look forward to increasing our market position in the midfoot and hindfoot segments with this exciting offering.”
    The addition of the JAWS™ Great White Staple System bolsters Paragon 28’s hindfoot solutions product offering, which includes the Gorilla® Ankle Fracture Plating System, APEX 3D™ Total Ankle Replacement, Silverback™ Ankle Fusion Plating System, Phantom® TTC Nail System, and Phantom® ActivCore™ Nail System.
  • With this comprehensive portfolio, Paragon 28® provides its customers with innovative ankle solutions for trauma, arthritis, and limb salvage.

Primo Medical Group Launches Trax Surgical, LLC

Retrieved on: 
Tuesday, September 26, 2023

STOUGHTON, Mass., Sept. 26, 2023 /PRNewswire/ -- Massachusetts based Primo Medical Group, a leader in the development, manufacture and assembly of quality medical devices, and precision machined custom components announced today the launch of their seventh start-up company. Trax Surgical LLC is an orthopedic product development and distribution company principally serving the needs of the orthopedic extremities market.

Key Points: 
  • STOUGHTON, Mass., Sept. 26, 2023 /PRNewswire/ -- Massachusetts based Primo Medical Group, a leader in the development, manufacture and assembly of quality medical devices, and precision machined custom components announced today the launch of their seventh start-up company.
  • Trax Surgical LLC is an orthopedic product development and distribution company principally serving the needs of the orthopedic extremities market.
  • Trax Surgical recently received FDA 510(k) clearance to market the TRAX Compression Screw System.
  • The TRAX Compression Screw System offers a wide range of bone screws for osteotomy, fixation, fusion, and fracture procedures.

OrthoPediatrics Corp. Announces the Launch and First Case Using the GIRO™ Growth Modulation System

Retrieved on: 
Tuesday, June 27, 2023

WARSAW, Ind., June 27, 2023 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced the limited launch and the completion of the first clinical case using the new GIRO Growth Modulation System.

Key Points: 
  • WARSAW, Ind., June 27, 2023 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced the limited launch and the completion of the first clinical case using the new GIRO Growth Modulation System.
  • The GIRO tether device is indicated for pediatric patients to aid in the correction of angular deformities of long bones and limb length discrepancy.
  • The GIRO Growth Modulation system represents the first new Pega Medical system to receive FDA clearance and be launched under OrthoPediatrics and the company’s 50th system for pediatric orthopedic care.
  • Joe Hauser, President of Trauma and Deformity Correction at OrthoPediatrics, added, “The first clinical case with the GIRO Growth Modulation system represents a milestone for our business as we continue to leverage the technology and expertise of our colleagues at OrthoPediatrics Canada.

New Aseptico® 1070 Series Implant Motor is Designed to Streamline and Simplify Workflow

Retrieved on: 
Friday, June 16, 2023

"The new 1070 Series Implant Motor is like the sports car of implant motors -- it has plenty of power and allows the dentist to have precise control of speed, torque, direction, irrigation flow, and presets, at the touch of a fingertip or tap on the multifunction foot control," said Stuart Kazen, Director of Domestic Sales for Aseptico Inc.

Key Points: 
  • The new Aseptico® 1070 Series Implant Motor is a powerful and efficient tool designed to streamline dental implant procedures.
  • Aseptico Inc. is introducing the new 1070 Series implant motor in response to clinicians who have expressed a desire for a simple, powerful, streamlined dental motor system that can handle implant cases efficiently without unnecessary complexity.
  • Sustainability-focused: The Aseptico® 1070 Series implant motor utilizes autoclavable irrigation tubing , reducing waste and saving costs compared to single-use, disposable tubing.
  • To learn more about the new Aseptico® 1070 Series Implant Motor and offer details, visit aseptico.com .

INSIDE INFORMATION: Bioretec updates its product pipeline to accelerate commercialization strategy following the first RemeOs™ FDA market authorization, and consequently updates financial targets

Retrieved on: 
Monday, April 24, 2023

TAMPERE, Finland, April 24, 2023 /PRNewswire/ -- Bioretec Ltd, a pioneer in bioabsorbable orthopedic implants, announced on 30 March 2023 that it had received U.S. market authorization for its RemeOs™ trauma screw from the U.S. Food and Drug Administration (FDA). Following the market authorization, the Board of Directors of Bioretec has today resolved to update and refocus the company's product portfolio to facilitate an accelerated commercialization strategy to provide a more synergistic offering responding to the market demand. Furthermore, Bioretec refines its U.S. go-to-market strategy to fit the company's resources better and provide enhanced possibilities to penetrate the vast U.S. market. Consequently, financial targets are updated to reflect the aforementioned strategic changes.

Key Points: 
  • Furthermore, Bioretec refines its U.S. go-to-market strategy to fit the company's resources better and provide enhanced possibilities to penetrate the vast U.S. market.
  • Additionally, Bioretec is also exploring possibilities to raise additional financing to accelerate the U.S. commercialization of RemeOs™ products, increasing manufacturing capacity, and enhancing product development, spearheaded by the RemeOs™ trauma screw.
  • Bioretec will focus on serving customers in the lower and upper extremities with products that have a faster commercialization strategy and provide a more synergistic offering.
  • To complement the RemeOs™ trauma screw product group, Bioretec has decided to add two new product groups, RemeOs™ staples and RemeOs™ plates to its product development pipeline.

INSIDE INFORMATION: Bioretec updates its product pipeline to accelerate commercialization strategy following the first RemeOs™ FDA market authorization, and consequently updates financial targets

Retrieved on: 
Monday, April 24, 2023

TAMPERE, Finland, April 24, 2023 /PRNewswire/ -- Bioretec Ltd, a pioneer in bioabsorbable orthopedic implants, announced on 30 March 2023 that it had received U.S. market authorization for its RemeOs™ trauma screw from the U.S. Food and Drug Administration (FDA). Following the market authorization, the Board of Directors of Bioretec has today resolved to update and refocus the company's product portfolio to facilitate an accelerated commercialization strategy to provide a more synergistic offering responding to the market demand. Furthermore, Bioretec refines its U.S. go-to-market strategy to fit the company's resources better and provide enhanced possibilities to penetrate the vast U.S. market. Consequently, financial targets are updated to reflect the aforementioned strategic changes.

Key Points: 
  • Furthermore, Bioretec refines its U.S. go-to-market strategy to fit the company's resources better and provide enhanced possibilities to penetrate the vast U.S. market.
  • Additionally, Bioretec is also exploring possibilities to raise additional financing to accelerate the U.S. commercialization of RemeOs™ products, increasing manufacturing capacity, and enhancing product development, spearheaded by the RemeOs™ trauma screw.
  • Bioretec will focus on serving customers in the lower and upper extremities with products that have a faster commercialization strategy and provide a more synergistic offering.
  • To complement the RemeOs™ trauma screw product group, Bioretec has decided to add two new product groups, RemeOs™ staples and RemeOs™ plates to its product development pipeline.

Bioretec is the first in the world to receive FDA approval for a bioresorbable metal product

Retrieved on: 
Thursday, March 30, 2023

Bioretec is the first and currently, the only medical device company to offer bioresorbable metal implants in the United States, the largest single market for orthopedic trauma products globally.

Key Points: 
  • Bioretec is the first and currently, the only medical device company to offer bioresorbable metal implants in the United States, the largest single market for orthopedic trauma products globally.
  • RemeOs™ trauma screws are based on a proprietary bioactive and osteopromotive magnesium alloy introducing a new generation of strong bioresorbable materials for enhanced surgical outcomes.
  • Bioresorbable metals combine the surgical techniques of traditional metal implants and the patient-friendly care and benefits of last-generation bioresorbable polymer implants.
  • Bioretec submitted the De Novo market authorization request to the FDA for the RemeOs™ trauma screw in May 2022.

Bioretec is the first in the world to receive FDA approval for a bioresorbable metal product

Retrieved on: 
Thursday, March 30, 2023

Bioretec is the first and currently, the only medical device company to offer bioresorbable metal implants in the United States, the largest single market for orthopedic trauma products globally.

Key Points: 
  • Bioretec is the first and currently, the only medical device company to offer bioresorbable metal implants in the United States, the largest single market for orthopedic trauma products globally.
  • RemeOs™ trauma screws are based on a proprietary bioactive and osteopromotive magnesium alloy introducing a new generation of strong bioresorbable materials for enhanced surgical outcomes.
  • Bioresorbable metals combine the surgical techniques of traditional metal implants and the patient-friendly care and benefits of last-generation bioresorbable polymer implants.
  • Bioretec submitted the De Novo market authorization request to the FDA for the RemeOs™ trauma screw in May 2022.

Research Published in JSES Indicates that the Catalyst™ CSR Total Shoulder System Outperforms Traditional Stemmed Implants

Retrieved on: 
Monday, March 6, 2023

“The Catalyst CSR anatomic shoulder system uses a multiplanar osteotomy that allows for superior precision and accuracy in shoulder replacement, while preserving more of the patient’s native bone,” said Matthew Budge, M.D.

Key Points: 
  • “The Catalyst CSR anatomic shoulder system uses a multiplanar osteotomy that allows for superior precision and accuracy in shoulder replacement, while preserving more of the patient’s native bone,” said Matthew Budge, M.D.
  • “This novel approach leverages both reproduction of the patient’s native humeral head height and offset with an ellipsoid anatomic head.
  • “Faster recoveries can be attributed to a combination of several factors working in unison,” said Carl O’Connell , CEO and president of Catalyst.
  • And patented, oblique glenoid instruments allow for the glenoid to be prepared with less muscle retraction than a traditional perpendicular approach.”