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Current & Critical

An Update on Generic and Low-cost Manufacturing Companies in Orthopaedics

By Julie A. Vetalice

It’s been a year since I shared that list on my wall of companies that operate in the generic and low-cost manufacturing/low-cost sales space, but the topic is still critical as stakeholders look for ways to drive new business, differently. Here are a few others I’ve added since then, to keep you apprised of who’s who in the marketplace.

B2B Spine (Back 2 Basics)
Baulkham Hills, NSW, Australia

  • Received first FDA 510(k) in 4Q12, for Dymaxeon posterior pedicle screw system: rod/screw with anatomical hooks, to primarily treat neuromuscular disorders, trauma, degenerative disease
  • Dymaxeon to be provided sterile and traceable, with individually packed pedicle screws (in pairs) plus rods of varying pre-contoured lengths
  • With B2B Direct, seeking to provide access lower cost, high quality spinal instrumentation without unnecessary expense
  • Delivery system will use advanced communication technologies to allow streamlined, reproducible delivery to the end user


Cardinal Health
Dublin, Ohio, USA

  • Distribution partner for Emerge Medical low-cost trauma products
  • Launched Orthopaedic Solutions in 2012: integrated offering to allow hospitals and surgery centers to reduce ordering costs and on-hand inventory; created specialized ValueLink Par Optimization program to reduce trauma implant inventory inside hospitals' processing areas
  • No separate procurement process or additional labor; next-day delivery
  • Offers analytics based upon customer supply chain data and clinical insights to drive inventory “right-sizing efforts”
  • Reports savings at 30% to 50% less than leading brands


Empower Spine
Pierceton, Indiana, USA

  • Spinal implants are U.S.-made by X-spine Systems, FDA-cleared, backed by clinical data, part of a comprehensive portfolio including cervical plates, pedicle screws, reduction screws, PEEK cages, facet screws, DBM, etc.
  • Claims savings of 40% to 70% less than current contract prices
  • Offers customized service and management options with no inter-operative upselling
  • Removes traditional sales distribution model


Intuitive Spine
Fort Myers, Florida

  • Specializes only in one FDA-cleared product, Discovery PEEK Cervical Intervertebral Fusion Device with Bone Graft
  • Identifies as a low-cost alternative: no reps, no advertising in journals, no promotion at
  • national meetings or other surgeon-directed marketing


Dayton, Ohio, USA

  • NovoKnee total knee is FDA-cleared for posterior stabilized and cruciate retaining applications; has also developed NovoHip total hip
  • To introduce revision, trauma and spine products in the future
  • Provides high-performance implants/service solutions at a breakthrough value point
  • Claims ability to save a typical practice $500,000 to $1MM/year with no changes in surgeon or patient behavior or techniques


Parcus Medical
Sarasota, Florida, USA

  • Distributes suture anchors, titanium and PEEK carbon fiber interference screws and ACL graft fixation accessories/instruments, etc., via low-cost manufacturing and direct-to-customer distribution
  • Claims one ASC customer’s savings of $17,000 on implants/associated costs on 1st 10 cases


Prodigy Orthopedics (Update: Business license expired 11/2013 per Nevada Secretary of State filings; web site out of service)
Georgetown, Texas, USA

  • Founded 2013, focusing on trauma, spine, sports medicine and total joints
  • Formed “to make high quality orthopedic products at the lowest possible cost passing these savings on to the end user”


Villoy Implants
Luckenwalde, Germany

  • Complete line of patent-free endoprostheses based on designs developed by surgeons like Spotorno, Müller, Zweymüller, etc.


Sources: Press releases, company web sites, articles in the public domain, FDA 510(k) Releasable Database