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Strategic Orthopaedic-related 510(k) Update

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

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

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

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

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

  • One Anterior Cervical Plate, 3 bone screws and either a PEEK IBFD or structural allograft/autograft
  • Designed to offer secure fixation with no profile

Sources: FDA 510(k) Releasable Database; company news releases, websites, etc.

   Find out more about 510(k) clearance strategies by reading these articles:

FDA Clarifies Substantial Equivalence Requirements for 510(k) Submissions

FDA Posts 510(k) Communication Timeline


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