Strategic Orthopaedic-related 510(k) Update

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk.

Advanced Interventional Technology
Swing-Off Screw, K130627

  • Titanium alloy, self-drilling, self-tapping
  • For application in small bone, Weil osteotomy, Mono-cortical fixation, osteotomies, etc.

CoreNexus
Nexus Anterior Cervical Plate, K131520*

  • Anterior fixation in cervical spine
  • For degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities or curvatures, etc.

Pedicle Screw System, K131522

  • Posterior spinal fixation for treatment of severe spondylolisthesis
  • Also cleared to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine

Crosstrees Medical
PVA Pod, K130089*

  • For delivery of bone cement to pathologic compression fractures of the vertebral body in levels T4-L-5 of thoracic and lumbar spine
  • Can be used with company‚Äôs Fortibrae Bone Cement

Emerge Medical
Locking 1/3 Tubular Plate System, K131480

  • Stainless steel system for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, including osteopenic bone

Ingen Orthopedics
Seviin Shoulder System: Reverse, K120374*; Surface Replacement, K130635, Fracture, K131277

  • Reverse: Ti-6A1-4V alloy metaglene plate with titanium plasma spray coating, Ti-6A1-4V alloy bone screws, Co-Cr-Mo alloy glenosphere, Co-Cr-Mo alloy humeral cup and UHMWPE inlay
  • Surface Replacement: Co-Cr-Mo alloy with polished spherical surface for articulation; inner surface of humeral heads coated with titanium plasma spray
  • Fracture: modular titanium alloy system; fracture humeral stems can be used with SEVIIN Total Shoulder Humeral Heads and Glenoids as well as Reverse Shoulder components

JG Spine
Surefix Interspinous Fusion System, K124014*

  • Posterior, non-pedicle, supplemental titanium alloy fixation devices; interspinous process implants; for use with graft; not standalone

Next Orthosurgical
Interform Interbody Cage, K131082*

  • PEEK cage, used with supplemental fixation and autogenous bone graft
  • Configurations for PLIF, TLIF, OTLIF, LLIF and ALIF approaches

Osseus Fusion Systems
Black Diamond Pedicle Screw System, K131810*

  • Titanium top-loading multiple component posterior spinal fixation system (screws, rods, crosslinks)

Shanghai Sanyou
Medical Katia Intervertebral Body System, K131512*

  • Titanium alloy system for anterior interbody screw fixation of cervical spine during cervical fusion

Vivorte
Bone Void Filler Lite, K131133*

  • Moldable, self-setting, gradually resorbable, biocompatible, calcium phosphate bone void filler
  • Isothermally hardens in vivo to form hydroxyapatite

Sources: FDA 510(k) Releasable Database, 7/13-8/13; news releases; company websites