Tag: bone graft
Cerapedics files final module of PMA application for new P-15 peptide...
Cerapedics has today announced that it has filed the final module in a premarket approval (PMA) application with the US Food and Drug Administration...
Cerapedics announces long-term data from pivotal study of i-FACTOR bone graft
Cerapedics has announced long-term follow-up data from its pivotal investigational device exemption (IDE) study of the i-FACTOR peptide-enhanced bone graft. Published data demonstrate fusion...
Biogennix’s DirectCell advanced bone grafting system used in 500th case
Biogennix has announced that its DirectCell advanced bone grafting system has now been used in more than 500 cases.
The DirectCell system includes a bone graft product with...
Cerapedics granted breakthrough device designation for P-15L bone graft
Cerapedics has announced that it has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for its investigational P-15L bone...
Sirakoss granted CE mark for synthetic bone graft substitute
Sirakoss has been granted CE mark clearance in the European Union (EU) for Osteo3, a novel nanosynthetic bone graft substitute designed to improve patient...
Bioventus launches OSTEOMATRIX biphasic bone graft
Bioventus has launched OSTEOMATRIX+, a biphasic bone graft for use in bone remodelling in a variety of orthopaedic and spine applications. OSTEOMATRIX+ is a mouldable bone graft substitute...
IVANOS study reveals i-FACTOR bone graft use more than doubles fusion...
Level 1 evidence, presented at EUROSPINE 2018 in Barcelona, Spain, demonstrates that i-FACTOR peptide enhanced bone graft results in significantly higher rates of fusion...
Use of i-FACTOR peptide enhanced bone graft more than doubles fusion...
The use of i-FACTOR peptide enhanced bone graft (Cerapedics) resulted in a 50% fusion rate, compared to a 20% fusion rate using allograft in...
Cerapedics receives FDA approval to initiate IDE study of P-15L bone...
Cerapedics, a privately-held orthobiologics company, has announced the company received approval from the US Food and Drug Administration (FDA) to initiate an investigational device...
i-FACTOR™: Small peptide, big impact
This article is sponsored by Cerapedics, Inc.
A FAST, RELIABLE AND PROVEN ALTERNATIVE TO AUTOGRAFT
i-FACTOR peptide-enhanced bone graft is challenging the gold standard in bone...
South Korea’s first rhBMP-2 bone graft receives government recognition
South Korean biomaterials company CG Bio has received a ‘World Class Product of Korea’ award from the Ministry of Trade, Industry and Energy and...
US FDA clears Prosidyan Fibergraft bone graft putty for posterolateral spinal...
Prosidyan, a developer of proprietary fibre-based bioactive glass products, has received US Food and Drug Administration (FDA) 510(k) clearance for its Fibergraft bone graft...
ChoiceSpine launches biologics portfolio
ChoiceSpine has launched a new biologics portfolio at its National Sales Meeting in Nashville, USA.
The Biologics product portfolio is marketed under two brands named...
Premier US healthcare improvement company to offer Bioventus’ full surgical portfolio
Bioventus has announced that its full surgical orthobiologics portfolio is now available through Premier, a US health care improvement company comprised of 3,750 US...
SurGenTec receives US patent for Graftgun bone graft delivery system
SurGenTec, a minimally invasive orthobiologics company, has announced that the United States Patent and Trademark Office (USPTO) has granted a new patent for its...
US FDA clears Amend Surgical NanoFuse BA
Amend Surgical has received US Food and Drug Administration (FDA) 510(K) clearance to market NanoFuse BA as a bone graft extender for spine and...
TranS1 launches Capital bone graft harvester
TranS1 has announced the release of the Capital bone graft harvester, a new device designed to allow for fast, reliable, and reproducible harvesting of...
Cerapedics awarded group purchasing agreement with Premier for I-Factor
Cerapedics has been awarded a group purchasing agreement with Premier, a healthcare improvement company.
The new agreement allows Premier members, at their discretion, to take...
NovaBone portfolio receives Brazilian medical device clearance
NovaBone has received the Brazilian ANVISA Good Manufacturing Practices (GMP) medical device certificate.
ANVISA is Brazil's equivalent to the US Food and Drug Administration (FDA),...