Company Profile

Theken Orthopaedic, Inc. founded in 1992 provides mechanical testing and FDA regulatory services to medical product manufactures in need of FDA device approval.

Theken Orthopaedic has one of the most technologically advanced implant testing facilities in the world, which incorporates several uniaxial and biaxial digital servohydraulic test systems. The testing configurations capable on these machines are endless, while the type of implant material tested ranges from titanium to polymer composites. Theken Orthopaedic exclusively tests medical implants and devices.

To market a medical product in the United States, a series of tests are conducted for FDA clearance. The data from the tests is collected and included in the 510k (report submitted to FDA for device clearance). This can be a time consuming process which may delay a product from coming to market. Theken Orthopaedic streamlines this process by providing accurate data in concise tables and graphs. This makes it easier for FDA regulatory officers to interpret the data and decrease the amount of time to obtain FDA clearance. Also, Theken Orthopaedic has worked with the FDA for years; this experience enables them to field questions and provide additional information requested to expedite the process for manufacturers.

For the past several years, Theken Orthopaedic has been partners in research with some of the foremost universities, hospitals, and clinics that specialize in orthopaedics. Theken Orthopaedic has provided the link between academia and the medical industry for those with the desire to participate in innovative orthopaedic research and development studies. Theken Orthopaedic draws on the expertise and experience of some of the finest creative minds in the international orthopaedic community. This allows them to deliver some of the most important inventions and technological breakthroughs the orthopaedic industry has seen. Through these collaborative efforts, several medical journal articles have been published.

Randy Theken (pronounced “taken”) is the founder of four orthopedic medical device companies, known as the Theken Family of Companies. Theken Orthopaedic, Inc. conducts mechanical testing of orthopedic implants for major medical device companies in need of FDA approval. Theken Spine, LLC designs, develops, manufacturers and distributes spinal fixation devices nationwide. Theken Disc, LLC designs and develops high-technology medical device products, such as a microelectronic artificial replacement spinal disc. Therics, LLC designs, develops and manufacturers a variety of synthetic bone substitute products. A master-degreed electrical and mechanical engineer, Randy Theken and his rapidly growing family of companies are making significant impact on the spinal implant industry.

Mr. Theken was born and raised in Northeast Ohio. He became interested in spinal implants while conducting research for his thesis at the University of Akron. After finishing graduate school, he founded Theken Orthopaedic. Five years later, he founded Theken Spine. In mid-2003, Theken Disc was founded to specifically focus on R&D development of next generation spinal arthroplasty devices. July 2005 Mr. Theken formed Therics, LLC as an Ohio limited liablity company through the purchase of ownership from Tredegar Corp.