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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.

Alliance Spine
Alamo P Intervertebral Fusion Device, K120401
• PEEK Optima® LTI with tantalum markers
• To facilitate bone integration/fusion from PLIF approach

Aston Medical
Tregor Dual Mobility Acetabular System, K111981*
• Metal acetabular cup/shell (stainless steel or cobalt chromium) and dual mobility UHMW polyethylene insert; cemented or cementless use
• Compatible with StelKast femoral components

DUOCENTRIC Reverse Shoulder, K103251
• UHMWPE humeral insert, other components stainless steel; humeral stem for cemented use unless coated with hydroxyapatite
• Glenoid baseplate double-coated with titanium and hydroxyapatite (Ti/HA), for cementless use

Iconacy Orthopedic Implants
I-Hip Total Hip, K121034*
• Titanium alloy femoral stem, cobalt chrome modular femoral head, titanium alloy cup HXL-UHMWPE liner, porous-coated components for cementless, press-fit fixation

Jazz Fixation System, K121541
• Intended for use with the Calypso pedicle screw during spinal surgery: trauma, reconstructive, deformity/degenerative correction, etc.

Intelligent Implant Systems
Active Bone Screw, K121682*
• Titanium, available in a 4.5 mm diameter size from 20 mm to 50 mm, non-sterile

Osseon Therapeutics
Osseoflex SB Inflatable Bone Tamp, K122533*
• For use with PMMA bone cements in the reduction/fixation of fractures or creation of a void in cancellous bone in the spine, including use during percutaneous vertebral augmentation

Providence Medical Technology
Bone Screws, K121713*
• Titanium alloy, headed or headless, for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation

Safe Orthopaedics
SteriSpine LC Cage, K122021
• Solid-machined PEEK, tantalum markers, to be used with bone graft and STERISPINE PS supplemental fixation

Shanghai Kinetic Medical
Kyphoplasty System, K113742*
• To be used with PMMA bone cement indicated for use during percutaneous vertebral augmentation

Shoulder Options
Aft Proximal Humerus Fracture Plate, K121672
• Titanium low-profile, anatomically shaped plate, available in long and short configurations with left and right options
• Plate contains holes for 3.5mm locking and nonlocking screws, 4.5mm partially threaded screws

Weigao Orthopaedic
Intramedullary Nail, K121312*
• Titanium alloy fixation IM nail designed fracture fixation/stabilization of the tibia

Bicera Resorbable Bone Substitute, K110949*
• 60% hydroxyapatite/40% beta-tricalcium sticks and granules

Sources: FDA 510k Releasable Database, 9/12-10/12; news releases; company web sites