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.

Arrowhead Medical Device Technologies
Arrow-Lok Digital Fusion System, K112675*

  • Stainless steel, 3-dimensional arrow shape for fixation of osteotomies, arthrodeses and reconstruction in lesser toes

Comprehensive Reverse Shoulder - El Humeral Bearings, K113121
Comprehensive Reverse Shoulder Humeral Tray, K113069

  • Indicated for-primary, fracture or revision total shoulder replacement; modifications to original K080642

Interface Bone Void Filler, K112857

  • For use in the posterolateral spine when mixed with autograft
  • Builds upon a previous clearance for use in the extremities and pelvis

R&R External Fixation System, K113106*

  • Aluminum, Ti6A14V alloy, stainless steel
  • For open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental or nonsegmental bony or soft tissue defects

Double Engine Medical Material
Locking Plate and Screw, K112819*

  • Company has products for trauma and spine

Eden Spine
Giza Thoracolumbar Vertebral Body Replacement, K112429

  • Titanium alloy
  • Expandable vertebral body replacement device featuring rotatable endplates to provide multiple angulation options

X-ing Spine Fixation System, K111995*

  • Pedicle screw for treatment of severe spondylolisthesis

Interventional Spine
Opticage Interbody Fusion Device, K113527

  • Titanium alloy
  • Posterior lumbar intervertebral body fusion device indicated for use with autogenous bone graft in patients with degenerative disc disease at 1 or 2 contiguous levels from L2-S 1
  • Reportedly the 1st and only system capable of enabling a complete percutaneous lumbar interbody fusion via 2 15mm incisions for the treatment of lumbar discogenic pain

Reprocessed Arthroscopic Shaver, K113028*

Merete Medical
OsteoBridgeo IDSF (Intramedullary Diaphyseal Segmental Defect Fixation) Rod System, K113303

  • For management of segmental diaphyseal bone loss of either humerus or tibia or femur in oncology patients secondary to radical bone loss and/or resection due to tumors

Spinal System, K113173

  • Titanium alloy
  • Intended for posterior, non-cervical pedicle and non-pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for treatment of acute and chronic instabilities or deformities

Orthopaedic Implant Company
Cannulated Screw System, Sliding Hip Screw System, K113123*

  • Manufacturer of low-cost implants; not physician-owned

Osteospring Medical
Footjack Subtalar Implant, K112658*

  • Titanium alloy, solid one-piece, conical, thread shaped and cannulated design

Pega Medical
Gap Endo-Exo Medularry System, K111232

  • For pediatric patients
  • Temporary implant to assure alignment, stabilization and fixation of long bones that have been surgically prepared for correction of deformities or fractures caused by trauma/disease

Shield Kyphoplasty System, K093477*

  • Features engineered strategic flow openings to provide bilateral cement placement in anterior 2/3 of vertebral body, while reducing amount of cement flow to posterior

Spinal Solutions
Lancer Pedicle Screw, K110633*

  • Titanium alloy
  • For modifications to Orthopedic Alliance Spine System; changes include geometry of pedicle screw head, add pedicle screw diameters, screw lengths, rod diameter, pre-bent rods and rod lengths

Suspension Orthopaedic Solutions
Clavicle Fracture Fixation System, K112923

  • Sole change to device is to allow optional, concurrent use of Suspension Acromnioclavicular System in instances where lateral clavicle fractures are encountered

Clavicle Fracture Fixation System, K113405

  • Extending product line by including a stainless steel plate specifically designed for mid-shaft (i.e., non-distal) clavicle fractures

Tarsus Medical
Synde-Lock Syndesmosis Repair Kit, K111971

  • One stainless steel screw + one PEEK T-nut, connected by distribution bridge comprising UHMWPE suture + threaded PEEK rod
  • For fixation during healing process following syndesmotic trauma

Sources: FDA 510(k) Releasable Database, 12/11 and 1/12, news releases, company web sites