510(k) Clearance & CE Mark for K2M’s MESA Hooks for Complex Spine Procedures

Our old friends at spinal device company K2M Group Holdings, Inc., newly in public hands, have received U.S. FDA 510(k) clearance for their MESA Hooks. The company has also received the CE Mark for the product, the latest implant addition to the MESA® Deformity Spinal System.

Background

The MESA Hook extension to the existing MESA Deformity Spinal System provides a unique low-profile option to this versatile system. The MESA Deformity System, designed for use in complex spine surgeries, contains a wide range of implants and instruments for the treatment of deformity, trauma and tumor. K2M’s low-profile, top-loading MESA Technology features Zero-Torque Technology®, which offers surgeons the ability to one-step lock without torsional stress applied to the spine. The MESA Hooks line extension includes a variety of transverse process hooks, laminar hooks and pedicle hooks.

In addition to MESA Hooks, the MESA Deformity Spinal System is comprised of MESA Foundation Screws, MESA Deformity Uniplanar Screws, MESA 360° Screws, Cobalt Chrome and Titanium Rods, and MESA Rails. The revolutionary design of the Reduction Jacks (Crickets), coupled with a complete offering of varied screw and hook types, provide surgeons with the ability to accomplish the most difficult correction maneuvers across all planes utilizing unique instrumentation for slow, controlled correction of the spine.

Physician comments

According to Hilali Noordeen, MA, BM BCh (Oxon), FRCS (Eng), MCh Orth., FRCS (Orth), a Consultant Spinal Surgeon at the Royal National Orthopaedic Hospital in the United Kingdom: “The MESA Hooks offer surgeons flexibility to complete an entire MESA construct. They allow for the use of Crickets® at every level, and they work well with MESA Rail™.”

Company comments

“We are pleased to receive 510(k) clearance and the CE Mark for MESA Hooks, which will enhance our portfolio and support our effort to expand our global penetration of the complex spine market with the MESA Spinal Deformity System. The unique low-profile MESA Hooks in combination with differentiated technology such as the MESA Rail provide surgeons with a wide range of fixation option for patients with severe spinal deformities,” stated Eric Major, K2M’s President and CEO. “These regulatory milestones are further examples of our commitment to innovation and achieving the highest level of excellence in the development of technologies to support surgeons treating the most complex spinal pathologies.”

Source: K2M Holdings, Inc., Globe Newswire

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