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Strategic Orthopaedic-related 510(k) Update

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. An asterisk denotes those receiving their first clearance for an orthopaedic product.

Expanding Orthopedics
FLXfit Intervertebral Body Fusion Device, K133813

  • Titanium device, height ranges from 8mm through 14mm
  • To be used with supplemental spinal fixation and autogenous bone graft
  • 1st surgery performed device recently occurred in France; U.S launch slated for 9/14

Flow-Nail, K140601*

  • Titanium alloy dynamic compression trochanteric nail system, compatible for use with injectable bone void fillers
  • Side-Port Cannula delivers BVF where needed through appropriate fenestrations while protecting the hip joint from unintended intrusion of biologic material (ETEX CarriGen and Beta-bsm)
  • Company fka Orthogen/Orthopedic Generations; other products include 2-can Multi-channeled Side Port Cannula, Flow-Screw, etc.

Infront Medical
Lumbar Interbody Fusion System, K141443*
Summary not available at press time.

Integrated Endoscopy
nuvis Arthroscope, K140903*

  • Indicated for use in arthroscopic procedures in the knee, shoulder, hip, wrist, temporal mandibular joint, ankle, elbow, feet

MBD Medical
MBD Plate System, K141045*

  • Titanium system intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula


Next Orthosurgical
Vertiform Posterior Fixation System, K141291
Summary not available at press time.

  • Other products include InterForm Lumbar Interbody System and retractor
  • Company also plans to develop recon, trauma devices

NovoHip Bipolar Head, Vitamin E Liner, Bone Screws, K140701

  • Intended for use with the NovoHip Total Hip; components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip

External Fixator Software, K140550*
Summary not available at press time.

  • Company incorporated in 2012, raised $109,000 in 2013
  • Per website, OrthoHub has developed a software program that allows orthopaedic surgeons to generate a prescription of strut adjustments using a ring and strut system to treat tibia deformities
  • Covered by U.S. Patent No. 8,654,150, issued in 1Q14

OT Medical
Instafix Shape Memory Fixation System, K141550*

  • NiTinol-based dynamic compression implants for use in hand/foot bone fragments, osteotomy fixation and joint arthrodesis
  • Packaged sterile with fully-disposable instrumentation

PONTiS Orthopaedics
Multifilament Stainless Steel Suture with Crimps, K133579

  • Intended for use in soft tissue-to-bone and bone-to-bone approximation and fixation in the elbow, foot, ankle, knee, shoulder and wrist

Sources: FDA 510(k) Releasable Database, 6/14-8/14; company news releases, web sites, etc.

   Find out more about clinical trial strategy by reading these articles:

Experts Offer Strategies for Clinical Trial Execution and Outsourcing

Post-Market Studies in Lieu of Clinical Trials


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