Horsham, Pa.-based Flower Orthopedics, the creator of the standardized, procedure-based, bone fixation concept the FlowerCube, has received CE mark. The approval, according to company officials, opens the opportunity for significant expansion of the FlowerCube concept in the European Union.
The approval encompasses Flower Orthopedics’ entire product line, which consists of complete bone fixation solutions for upper and lower extremities. Consisting of more than 400 implants, including a full portfolio of cannulated screws, each implant has been engineered with a clear surgical strategy in mind to provide the ultimate in secure bone fixation.
Flower Orthopedics’ single-use instruments are standardized and multifunctional, expediting case completion and driving surgical efficiency in the operating room (O.R.).
Tailored for specific surgical indications, the FlowerCube houses all of the requisite bone fixation implants and instruments sterile packaged, single-use and always Ready-for-Surgery. The FlowerCube is delivered ready for use, eliminating set drop off and preoperative on-site sterilization.
“Receiving CE marking approval is a significant milestone for Flower Orthopedics. The market response to the FlowerCube concept, to our anatomic implants and to the single-use instruments in the United States has been extremely positive, and we are excited to bring this concept to the European market," said Oliver Burckhardt, CEO and president of Flower Orthopedics. “We are committed to providing our customers in the United States and Europe cost-effective, safe and efficient Ready-for-SurgeryTM treatment solutions that bring true quantifiable value into to the O.R.”
Flower Orthopedics is actively seeking distribution partners in the Europe, and is looking to start selling activities in the region in 2016.
Flower Orthopedics’ “Ready-for-Surgery” concept provides surgery-specific applications in individual sterile packaging, which eliminates the need for pre-op sterilization and, compared to current practices, considerably reduces the number of implants and instruments brought into the operating room. All instruments in the FlowerCube are single-use, removing the need to reprocess surgical tools post-op. This single-use feature also decreases the risk of infection stemming from reusable devices and expedites valuable operating room turnaround time. With these efficiencies, the company expects hospitals and ambulatory surgical centers (ASCs) to save as much as 30 percent of the combined implant and instrument costs currently spent on each surgical case.