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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.

External Fixator, K113384

  • For knee or elbow applications
  • For elbow: applications include fracture dislocation w/ligament instability; comminuted intra-articular fracture, post-traumatic recon for joint stiffness
  • For knee: applications include leg lengthening, osteotomy, arthrodesis, fracture fixation, etc.

Cervical Plate, K113170

  • All components ASTM F-136 alloy
  • Company focuses on products that can be “adopted by surgeons without having to attend a specialty training course, and can be serviced and re-ordered by hospital or surgery center staff without assistance from an on-site company representative.”

Force Medical
IM Nail System, K102577*

  • High Strength 6-4 Titanium Alloy to ASTM F 136
  • Intended for tibiotalocalcaneal arthrodesis, stabilization of hindfoot and ankle including transverse tarsal joints coupling mid-foot to the hindfoot

2GC Hip/Knee Modular Spacer, K112470*

  • Both devices made from fully formed polymethylmethacrylate, radiopaque, contain gentamicin

Microware Precision
Bone Plates and Screws, K111008

  • Extension of earlier 510(k), includes new screws, washers, etc.
  • Clearance includes new recommended sterilization parameters

Tempus Cervical Plate, K120515*

  • Titanium alloy meeting requirements of ASTM F136,
  • Company “dedicated to exploring cost-effective approaches and less-invasive surgical options that provide optimal outcomes for the surgeon and the patient.”

Pipeline Orthopedics
Neo CR Knee, K120313

  • Company focuses on implants that can be used with navigation and robotic bone preparations

Ayers Rock Cervical Cage, K112801
Mont Blanc Pedicle Screw, K112684
Twin Peaks Lumbar Cage, K112696*

  • Company focuses upon “off-patent products that have years of success in the market,” bringing them to customers “direct and without the extra middleman costs”

R&D Innovation
Pedicle Screw System, K120091*

  • Features matched left and right “housings” that are secured to parallel, vertically oriented titanium rods + pre-contoured transverse titanium rod that is linked to housings by universal ball joint clamps contained within housings
  • Wide angulations between rod and crosslink allow preservation of important midline bone and ligament structures necessary to minimize potential for instability and breakdown of disc above the fusion

Science for Biomaterials
Otis-C Plus Plate, K120818

  • For stabilization of High Tibial Osteotomy with medial approach

Spinal Access System, K113352

  • Endoscope and instrument for minimally invasive visualization and access to anterior spine
  • Includes left and right orientation guides, fixation pins, drills, etc.

Sources: FDA 510(k) Releasable Database, 4/12 and 5/12, news releases, company web sites