First Orthopedic FDA 510(k) Clearances in Joint Replacement, Spine and Trauma

This month’s recap keeps it brief, introducing three companies that received their first orthopedic-related FDA 510(k) clearances in recent months.

Here, we meet Ormed, OrthoFundamentals and Fixier, based in Turkey, the U.S. and Mexico, respectively.

Joint Replacement

Ormed | OGM 1 and OGM 1A Polymethylmethacrylate Bone Cement, K211869
Submitted June 2021, granted May 2022
Primary predicate: Heraeus Medical PALACOS R, K202475, and PALACOS R+G, K202475

• About the product: OGM 1 is a PMMA bone cement intended for use in arthroplasty procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone. OGM 1A is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
• About the company: Established in 2012 in Ankara, Turkey. Product portfolio includes bone cement with antibiotic and bone cement for vertebroplasty and veterinary procedures, as well as antibiotic-laden spacers for knee, hip and shoulder.

Spine

OrthoFundamentals SI Screw

OrthoFundamentals | TRELLIS SI Joint Fusion System, K212962
Submitted September 2021, granted April 2022
Primary predicate: OrthoFix Firebird SI, K203138

• About the product: Suitable for outpatient procedures. Intended for fixation of sacroiliac joint disruptions, treatment of degenerative sacroiliitis, to augment immobilization and stabilization and to treat acute, non-acute and non-traumatic fractures of the SI joint.
• About the company: Founded in 2021, based in Medford, Massachusetts. Delivers additively manufactured implants and one-time use procedural kits that are managed and delivered through a cloud-based platform and RepOnDemand service. Leadership brings experience from Arthrex, Connective Orthopaedics, DePuy Spine and MX Orthopedics.

Trauma

Fixier Traufix Clavicle Plate

Fixier | Traufix Osteosynthesis Osteotomy and Arthrodesis Devices, K201510
Submitted June 2020, granted February 2022

• About the product: Intended for fixation of fractures and osteotomies of various bones including the pelvis, clavicle, scapula, humerus, ulna, radius, femus, tibia, olecranon and fibula.
• About the company: Established in 2012 in León, Guanajuato, Mexico.

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