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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.

Arthrosurface
ToeMotion, K132496
• Two-piece total toe, proximal phalanx implant

Changzhou Dean Medical Instrument
Locking Compression Bone Plates and Screws, K133525*
• Metallic devices for fixation of fractures, including ulna, radius and tibia, in adult patients

Ellipse Technologies
MAGEC (MAGnetic Expansion Control) Spinal Bracing and Distraction System, K140178
• For use in skeletally immature patients less than 10 years of age with severe progressive spinal deformities
• Sterile, single-use titanium rod, surgically implanted with Stryker Xia fixation components, includes an actuator portion that holds a small magnet
• Includes non-sterile, hand held External Remote Controller that is used after implant to non-invasively lengthen or shorten the implanted spinal rod by rotating the magnet

Epix Orthopaedics
VAN Hip Fracture System, K133104*
• Indicated for fixation of fractures of the femur (intertrochanteric, pertrochanteric, subtrochanteric fractures) and combinations of these fractures, pathological fractures in diaphyseal and trochanteric areas, nonunion or malunion

Extremity Medical
HammerFiX, K133636
• Sterile, threaded PEEK implant and instruments for use in the proximal interphalangeal joints of lesser toes of the foot

Flower Orthopedics
Rear Foot Plating Set, K133930
• Titanium devices for internal fixation of fracture/reconstruction of bones of the rear foot, including calcaneus

Innova Spinal Technologies
Elite Expandable Intervertebral Fusion Device, K133459*
• For use with autogenous bone graft and supplemental internal fixation, such as a pedicle screw or anterior plate
• Patients should have received minimum 6 months of non-operative treatment prior to surgery

MTP Solutions
PEEK Fusion Implant, K133515
• For fixation of osteotomies and reconstruction of lesser toes following correction procedures for hammertoe, claw toe, mallet toe

NovoSource
NovoHip Total Hip System, K132158
• Non-cemented hip prosthesis, comprising femoral stem, femoral head, acetabular poly liner and acetabular shell components

Nexus Spine
PressON Spinal Fixation System, K133287*
• Titanium posterior non-cervical pedicle screw system

Ortho Development
KASM Knee Articulating Spacer Molds, K133449
• Femoral and tibial molds for use in 2-stage revision knee arthroplasty

Prosidyan
BG Morsels, K132805*
• Osteoconductive, resorbable, biocompatible calcium salt bone graft substitute, made from crystalline 45S5 bioactive glass
• Not indicated for load-bearing applications

Shoulder Options
Greater Tuberosity Fracture Plate, K133668
• Reportedly first device designed specifically for treatment of greater tuberosity fractures of proximal humerus
• Titanium cannulated screws intended for fracture fixation of long bones/long bone fragments; fracture plate for fractures, fracture dislocations, osteotomies, nonunions of the proximal humerus, particularly in osteopenic bone

Synchro Medical
ToeGrip, Implant for Proximal Interphalangeal Arthrodesis, K133477*
• PEEK-based, press-fit device comprising monobloc implant with 3 flexible prongs inserted intramedullary into each part of phalanx

Twin Star Medical
Extremity Compartment Syndrome Monitor, Fluid Collection System, K131966
• For immediate or continuous measurement of intracompartmental pressures, withdrawal of fluid for subsequent analysis as an aid in the diagnosis of compartment syndrome

Tyber Medical
Trauma Screw, K133842
• General trauma screw for bone compression/fixation of bone
• Sterile and non-sterile implants in solid and cannulated designs, composed of titanium and stainless steel


Source: FDA 510(k) Releasable Database, 2/14-3/14; news releases, company websites, etc.

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