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510(k) Recap: New Products from Companies You Know

When recapping U.S. regulatory activities, I typically point out companies that are entering this market for the first time with a first product clearance. That’s useful information, because it keeps you apprised of new players.

Here’s a different approach: what about those that we already know? What are they doing to support new product launches that maintain growth?

The following companies received U.S. regulatory clearances or approvals within 1H18. It’s not intended to be a comprehensive list—but a quick look at what some of your peers are doing.

      Image result for Additive Orthopaedics | Patient Specific 3D Printed Bone Segments
     

Additive Orthopaedics' Patient Specific
3D Printed Bone Segment

Additive Orthopaedics | Patient Specific 3D Printed Bone Segments | K180239

  • For ankle and foot fixation
  • Per leadership, these lattice structures have shown close to 90% bony ingrowth after six months, with no use of biologics

Amedica | Valeo C+CSC with Lumen Interbody Fusion Device | K173453

  • Composite implant comprising silicon nitride ceramic in varying densities and an outer shell of solid silicon nitride surrounding a porous core of CsC (Cancellous structured Ceramic)
  • Published clinical data from the CASCADE clinical trial suggest that CsC may achieve spinal fusion without added bone grafts, with success rates at least as favorable as bone autograft

We’ll just list what Arthrex has done in 1H: one biologic, three joint reconstruction and the rest sports medicine. I noted that for all of 2017, Arthrex gained clearance for 10 products. Halfway through this year, they’re already at 11.

  • Angel System Kit, Platelet/Plasma Separator (BK180180)
  • Corkscrew FT (K173788)
  • FastThread Interference Screw (K180662)
  • FibuLock Nail (K173656)
  • Knotless SutureTak Anchors (K180594)
  • NanoSuture Anchor (K180118)
  • PushLock (K173240)
  • Shoulder System (K171841)
  • Thrombinator for use with the Angel System (BK170144)
  • Univers Revers Coated Baseplate (K172371)
  • Univers Revers Modular Glenoid (K173900)

Corin | Trinity PLUS Acetabular Shell | K172551

  • Can be used with all Trinity bearings and complements the Trinity Dual Mobility Hip, which launched in 1Q18
  • Limited launch in 2018; full launch in early 2019
  • CE Mark approval is forthcoming

DJO commenced a series of product launches at the end of 2Q, with more planned in 3Q to fuel double-digit growth in hip and knee (as well as the entire business). As mentioned in the 1Q18 earnings call, the company planned seven surgical implant launches for this year, with six slated for hip/knee. Here are two knee recon clearances for the year, so far:

  • EMPOWR Universal Tibial Baseplate (K173723)
  • EMPOWR VVC Tibial Insert (K180930)

Exactech | Equinoxe Stemless Shoulder | K173388

  • Bone- and canal-sparing implant features a 3D porous structure and bone cage to enhance biologic fixation
  • Requires a single instrument tray
  • Limited launch is underway, expanded release in 2H18
      GauthierIntellitorqElectronicTorque Indicator
     

Gauthier Biomedical's Intellitorq
Electronic Torque Indicator/ITQ

Gauthier Biomedical | Intellitorq Electronic Torque Indicator/ITQ | K180092

IlluminOss Medical | Bone Stabilization System | DEN160062

  • Represents FDA’s first de novo clearance under the orthopaedic panel
  • Outcomes data from a 13-site, 80-patient trial supported submission of the company’s de novo application
  • Performed through a small percutaneous incision, the procedure uses a light-curable liquid monomer contained within an expandable PET balloon catheter to achieve stabilization
  • Once the implant is cured and polymerized, it conforms to the geometry of a patient’s intramedullary canal
  • Launched in 2Q18

Orthofix | FORZA XP Expandable Spacer System | K172696

  • For posterior and transforaminal lumbar interbody fusion
  • Designed to give continuous, controlled expansion followed by an automatic locking feature
  • Intended for use with autograft and/or allograft and supplemental fixation such as Trinity ELITE allograft tissue and Firebird Spinal Fixation
  • Launched in 1Q18
      OrthofixFORZAXPExpandableSpacerSystem
       
     

Orthofix'S FORZA XP Expandable Spacer System 

Wright Medical | Augment Injectable Synthetic Bone Void Filler | P100006

  • (Yes, this is a PMA, not a 510(k))
  • Recombinant human platelet derived growth factor (rhPDGF-BB) plus collagen and Beta tri-calcium phosphate
  • Indicated as an alternative to autograft in arthrodesis of the ankle and/or hindfoot
  • Expected to contribute $3MM in 2H18 revenue; initially, will cannibalize “classic” AUGMENT sales, but is expected to move deeper into existing accounts due to improved handling characteristics vs. the legacy version

Zimmer Biomet | Zyston Strut Open Titanium Spacer System | K171495

  • Company’s first titanium spinal implant manufactured via 3D printing
  • Line of lumbar cages designed to enhance strength, graft capacity and visualization of the spacer, sized for a range of anatomies and surgical approaches
  • Includes instruments for insertion, manipulation and implant removal

Sources: Press releases, company websites, FDA.gov; images courtesy of manufacturers



Julie Vetalice is ORTHOWORLD’s Editorial Assistant. She can be reached by 
email.

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