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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.

B2B Spine
Dymaxeon Fixation System, K121786*

  • Titanium alloy posterior pedicle screw system for temporary stabilization during fusion in the treatment of instabilities or deformities of thoracic, lumbar and sacral/iliac spine
  • Can be used for single or multiple level fixations

Brainlab
Hip Navigation Software, K122011

  • Intraoperative image-guided system for total hip replacement and for surface replacement
  • Changes to predicate device (basic technology not changed):
    • Reduces user interaction with system, enables faster run through registration and navigation
    • Reduces number of landmarks to be acquired
    • Integrated distance measurement tool to check cup implant seating on acetabular floor
    • Integrated method for verification of head implant (for surface replacement)
    • Integrates new implants and instruments

Christopher D. Endara
External Fixator System, K122208*

  • Clamps, rods, Schanz screws for limb lengthening, osteotomies, arthrodesis, fracture fixation, etc.
  • Principal affiliated with Orbis Medical

Emerge Medical
Solid Bone Screws, K K122489

  • Titanium alloy and stainless steel non-sterile cancellous, cortical and shaft screws with washers

Everest Spine
Galleon Pedicle Screw, K122814*

  • Titanium alloy posterior, noncervical fixation for severe spondylolisthesis of L5-S I vertebrae, trauma, stenosis, curvatures, etc.

Fairway Medical
Viceroy Pedicle Screw Fixation System, K122229*

  • Titanium alloy fixation system for non-cervical posterior spine (TI -SI1) in skeletally mature patients

Foundry (Newco XI)
Cincher 2.6 Suture Anchor, K122954*

  • PEEK polymer suture anchor preloaded with polyethylene suture, loaded on a insertion tool to facilitate fixation of soft tissue to bone in hip, shoulder, foot, ankle, elbow, wrist, hand, knee
  • Foundry is a medical device incubator

Frontier Medical
Lateral Locking Cage Interbody Fusion Device, K112700*

  • Titanium alloy and PEEK Optima device for treatment of degenerative disc disease at one level from L2-L5
  • Locks to vertebra above and below disc space

InSurgical
Single Use Power Accessory, K112599*

  • Power tools (drill and reamer) and rechargeable batteries

NCS Lab
Fish-Fit MD and Compass MD Soft Tissue Fixation Systems, K120356*

  • Titanium single use, implantable suture anchor + reusable surgical instruments
  • For reattachment of tendon to bone in rotator cuff repair

Ouroboros Medical
XTool Arthroscope, K122861*

  • Discectomy instrument for open and minimally invasive procedures
  • Company’s spinal fusion product is CE Marked

Stabiliz Orthopaedics
Fixation System, K120651*

  • LCP plates, metal locking screws, cortical and cancellous screws for fixation of fractures, osteotomies and nonunions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula
  • Company’s mission: “develop novel enhancements to orthopedic medical devices utilizing FDA approved technologies to foster greater clinical outcomes while reducing costs for burden healthcare systems”

Z-Medical
Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple, etc. K121277*

  • Screws for foot/ankle applications to be exclusively distributed by Nextremity Solutions under Precision Ready brand

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

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