Strategic Orthopaedic-related 510(k) Update

by BONEZONE Editors on Dec 09, 2014

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. An asterisk denotes those receiving their first clearance for an orthopaedic product.

CrossRoads Extremity Systems
CrossCLIP Implant System, K142727*

Summary not available at press time
Website notes, “Launching a New Vision in Q4, 2014”

InFront Medical
InFront Lumbar Interbody Fusion System, K141443*

Indicated for skeletally mature patients with Degenerative Disc Disease at 1 or 2 contiguous levels from L2-S1
Must be used with supplemental fixation, indicated for use with autograft bone

Nanovis
FortiCore Intervertebral Body Fusion Device with Bone Graft, K140280

For use as a cervical or lumbar device for spinal fusion procedures in skeletally mature patients with degenerative disc disease
To be used with autogenous bone graft and in combination with supplemental fixation

OrthoHub
External Fixator Software, K140550*

Used with Smith & Nephew Taylor Spatial Frame rings and struts to treat traumatic or reconstructive tibia deformities
Generates a prescription of strut adjustments to provide to the patient
Covered by U.S. Patent No. 8,654,150, issued February 2014

Orthorebirth
Rebossis Bone Void Filler, K142090*

Summary not available at press time
Product is a resorbable cottony flexible synthetic bone material comprising calcium carbonate + silicate + polylactic acid, electrospun into fiber; can be mixed with autograft

Valeris Medical
Apollo Suture Anchor System and Titan Screw, K142230*

Titanium alloy or PEEK (Zeniva ZA-500) from Solvay Advanced Polymers
For fixation of ligament, tendon, bone or soft tissue to bone in knee, shoulder, foot/ankle, elbow, hand/wrist

Xenco Medical
Cervical Interbody System, K140786*

For spinal fusion procedures at 1 level in skeletally mature patients with degenerative disc disease
To be implanted via an open, anterior approach and packed with autogenous bone
To be used with supplemental fixation

Zavation
Zvplasty, K141419*

For the reduction of fractures and/or creation of a void in cancellous bone in the spine, including use during percutaneous vertebral augmentation
To be used with cleared spinal PMMA bone cements indicated for use during percutaneous vertebral augmentation (such as kyphoplasty)

Zimmer Spine
Optio-C Anterior Cervical System, K141500