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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 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

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

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

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

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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