Strategic Orthopaedic-related 510(k) Update

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

Cogent Spine
Med-LIF Intervertebral Fusion Device, K132738*

  • Two PEEK spacers with axial voids to contain bone graft material, titanium linkage that connects the PEEK spacers, angular anti-migration teeth and tantalum x-ray markers
  • Inserted via open or minimally invasive approach, may be placed as a single implant or as 2 units bilaterally in the same intervertebral space

GenOssis
OptOssol Compression Device System, K140875*

  • Comprises screws designed to compact juxtaposed bone fragments in compression to enhance healing and fusion through immobilization of the fragments with or without use of bone graft
  • Indicated for use in internal fixation of fractures, fusions and revisions; intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery but not intended for spine

IMEDICOM
Medinaut Kyphoplasty System, K133669*

  • Designed to reduce spinal compression fracture and restore sagittal alignment, use with PMMA bone cement
  • Comprises balloon catheter, bone expander syringe, expander, spacer, etc.; sterile, single-use

Impact Medical
Orthopaedic Fixation Systems, K140216*

  • Plates, screws, K-wires; non-sterile, 316L stainless steel
  • Indicated for use in small and long bones

In2bones
I.B.S. Snap-Off Screw/Solafix Snap-Off Screw, K132911*

  • 1-piece titanium self-drilling/self-tapping screw, sterile
  • Intended for bone reconstruction, osteotomy and fixation

MBD Medical
MBD Plate System, K141045*

  • Database summary not available at time of publication
  • Company is a joint venture between Thomas D. Meade, MD and medical design company BioDynamics; seeks to market innovative plate and screw system for surgical repair of displaced clavicles, resulting in superior clinical outcomes vs. traditional non-operative therapy

Ouroboros Medical
XCage Interbody Fusion System, K133514

  • Expandable device intended for use in lumbosacral spine from L2 to S1
  • PEEK Shell and titanium Shim components offered in a range of sizes
  • For use with autogenous bone graft

PAN Medical
InterV Kyphoplasty Catheter, K132620*

  • Single-use double lumen catheter with low profile balloon mounted on distal tip
  • Intended for reduction and fixation of fractures/creation of void in cancellous bone in spine during balloon kyphoplasty with cleared spinal PMMA bone cement

PONTiS Orthopaedics
ferroFIBRE Stainless Steel Suture with Crimp, K140127*

  • Nonabsorbable sterile suture previously cleared (K081060, Core Essence Orthopaedics); crimp added as alternative to knot tying
  • For use in certain orthopaedic procedures, including cerclage and tendon repair

Paragon 28
ParaLock Plating System/TUFFNEK Screw, K140397

  • Titanium/titanium alloy lower extremity systems for adult and pediatric patients
  • Offered in mini and standard set sizes; TUFFNEK offered in locking and non-locking versions

Safeeire
Y-Wire 2 Guidewire, K140576*

  • Nitinol device, intended to assist with proper introduction/placement of orthopaedic instruments and implants

Sources: FDA 510(k) Releasable Database, 4/14-6/15; news releases, company web sites, etc.

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