Premarket Approval

August 10, 2022

AxioMed Submits Final Module III to FDA

AxioMed Submits Final Module III to FDA
AxioMed will be the first lumbar viscoelastic total disc replacement company to complete a U.S. IDE clinical trial.
July 13, 2022

FDA Accepts Empirical Spine’s Limiflex PMA Module II

FDA Accepts Empirical Spine’s Limiflex PMA Module II
The LimiFlex DST is a first-of-its-kind surgical option for grade 1 degenerative spondylolisthesis patients with spinal stenosis.
March 30, 2022

FDA Approves CartiHeal’s Agili-C Implant

FDA Approves CartiHeal’s Agili-C Implant
Approval is based on results of a clinical study that demonstrated superiority of Agili-C to debridement and microfracture in the knee joint.
July 22, 2020

Cerapedics Gains FDA Approval of IDE Supplement

Cerapedics Gains FDA Approval of IDE Supplement
The IDE Supplement allows for a reduction in the number of patients required to be enrolled in the ASPIRE IDE Study on P15-L bone graft in the lumbar spine.
November 18, 2019

Cerapedics Gains FDA Approval of PMA Supplement for i-FACTOR

Cerapedics Gains FDA Approval of PMA Supplement for i-FACTOR
FDA approved Cerapedics' Premarket Approval supplement for i-FACTOR® Peptide Enhanced Bone Graft for use in ACDF to treat degenerative cervical disc disease.
September 5, 2017

Bioventus Receives FDA Premarket Approval for DUROLANE

Bioventus received FDA premarket approval for DUROLANE single-injection hyaluronic acid to treat pain associated with knee osteoarthritis.
December 20, 2016

FDA Approves Investigational Device Exemption for Agili-C Implant

CartiHeal received FDA approval of its Investigational Device Exemption application submitted for the Agili-C™ implant, in support of a Premarket Approval application.
March 8, 2016

FDA Panel to Convene on PMA for Cartiva’s Synthetic Cartilage Implant

On 4/20/16, FDA's Orthopaedic and Rehabilitation Devices Panel will meet regarding the PMA for Cartiva's Synthetic Cartilage Implant, an organic polymer-based biomaterial designed to mimic biologic cartilage.