successcros.blogg.se - Staples micromate

Portfolio includes endoscopic spinal technology, 3D-printed solid and expandable cages, a percutaneous system and a demineralized bone matrix.

About the company: Established in 2019, headquartered in Irvine, California.

About the product: Titanium alloy top-loading multiple component, posterior spinal fixation systems comprising pedicle screws, rods, set screws, connectors and transverse linking mechanisms company’s first FDA 510(k) clearance.

Predicate device: Globus Medical REVERE Stabilization System, K061202 and and K093294.

Goblin and Goblin LS Pedicle Screw Systems, K210420 submitted February 2021, granted April 2021

Leadership brings experience from Biomet, DJO Global, Stryker. From 2015 through 2020, Onkos has raised $25.2 million in funding over three rounds. About the company: Formed in 2015, based in Parsippany, New Jersey, beginning with a specialized focus on sarcoma, cancer that develops in bone and connective soft tissue.The clearance also includes an oval shaped collar design to provide greater contact in distal femoral replacements, where subsidence is a common challenge among complex revision and trauma applications. The BioGrip collar is designed to help provide bone ingrowth at the bone/implant interface, accelerating and enhancing osseointegration. About the product: Modular collar portfolio featuring BioGrip 3D-printed porous implant structure, created to help address the clinical challenge of aseptic loosening in musculoskeletal oncology and complex orthopedic limb salvage.Primary predicate: Onkos Surgical ELEOS Limb Salvage System with BioGrip, K203090.Joint Replacement Onkos SurgicalĮLEOS Limb Salvage System With BioGrip, K203815 submitted December 2020, granted June 2021

I found these to be of interest, as they are granted to primarily lesser-known companies. In considering FDA 510(k)s from this year, we look at five from across the orthopedic market.