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.

Apogee OrthoSolutions
Monster Screw System, KK124027*
Titanium alloy and stainless steel
For use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device

Biomedical Enterprises
Speed Shift Staple, K124022
Summary data not available at press time.

Cleveland Clinic/Custom Orthopaedic Solutions
Glenoid Intelligent Reusable Instrument (IRIS), K123122
Patient-specific manual instrument system intended for use in preoperative planning/intraoperative placement of central glenoid guide pin; indicated for use with the DePuy Anchor Peg Glenoid component of the DePuy AP Shoulder System, DePuy Global StepTech Glenoid component or the DePuy Delta Xtend Reverse Shoulder metaglene component as an alternative to standard instruments
Not indicated for use in hemi-shoulder arthroplasty

Institute of Musculoskeletal Science & Education
IMSE P-TLIF Intervertebral Fusion Device, K130506*
Summary data not available at press time.

Nitinol Staple Implant, K123926
Summary data not available at press time.

NovoKnee Total Knee System, K123339*
Class II device, Knee joint patellafemorotibial polymer/metal/polymer semiconstrained cemented prosthesis
Fixed bearing, posterior-stabilized design
May also be indicated in the salvage of previously failed surgical attempts if knee can be satisfactorily balanced and stabilized at time of surgery

NUTEK Orthopaedics
NBX Non-Bridging External Fixator – Hand, K122777
For treatment of open or closed fractures and malunion/nonunion of metacarpals and phalanges of and
Product slated for early 3Q13

Pantheon Spinal
Spinal Interbody Fusion Device, K113781*
Summary data not available at press time.

Providence Medical Technology
PMT Cervical Cage, K122801
Device to launch in 3Q13
Summary data not available at press time.

SIGN Fracture Care
Pediatric Fin Nail, K122823
Stainless steel Intramedullary Fixation Rod for insertion into medullary canal of femur for fixation of fractures without distal interlocking screws or external fixation

Synergy Biomedical
Biosphere Bioactive Bone Graft Putty, K122868
Osteocondluctive, bloactive bone void filler that comprising 45S5 bioactive glass particles mixed with inert, moldable carrier
Indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure

X-Spine Systems
Zygafix Spinal Facet Screw System, K123932
For fusion/stabilization of zygapophyseal joint
Hollow fenestrated titanium compression screw with internal bone graft that may be placed via trans-facet approach to achieve solid fusion

Xiamen Double Engine Medical Material
Bone Plate and Screw System, K130108
Titanium and titanium alloy
For fixation of fractures of large bone (clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, fibula) and small bone (metacarpals, metatarsals, and phalanges)

Sources: FDA 510(k) Releasable Database, 4/13-5/13; news release; company web sites