thekendiscLogo.jpg

Randy Theken founded Theken Orthopaedic, Inc in 1992 providing mechanical testing and FDA regulatory services to medical device companies in need of product FDA approval. By 1998, Theken Orthopaedic had formed relationships with nearly every orthopedic device manufacturer in the US, and most residing in Europe. At it's peak, Theken generated hundreds of FDA submissions each year, in addition to providing product development and research and development services.
Fewer Parts, Fewer Steps.


Media


510(k) Mechanical Test Reports

Theken, R.R. Technical Report 091195-001. Submitted to Ace Medical Company, El Segundo, CA, September 11, 1995.

Marcinek, S.A. Technical Report 110895-002. Submitted to Ace Medical Company, El Segundo, CA, November 8, 1995.

Theken, R.R. Technical Report 092795-003. Submitted to Ace Medical Company, El Segundo, CA, September 27, 1995.

Theken, R.R. Technical Report 111295-004. Submitted to Ace Medical Company, El Segundo, CA, November 11, 1995.

Theken, R.R. Technical Report 010896-00 Submitted to Ace Medical Company, El Segundo, CA, January 8, 1996.

Theken, R.R. Technical Report 042896-006. Submitted to Ace Medical Company, El Segundo, CA, April 30, 1996.

Theken, R.R. and Njus, G.O.: Technical Report 092691-028. Submitted to AcroMed Corporation, Cleveland, OH, September 26, 1991.

Theken, R.R. and Njus, G.O.: Technical Report 050691-033. Submitted to AcroMed Corporation , Cleveland, OH, May 6, 1991.

Theken, R.R.: Technical Report 061994-001. Submitted to AcroMed Corporation, Cleveland, OH, June 15, 1994.

Theken, R.R.: Technical Report 102194-002. Submitted to AcroMed Corporation, Cleveland, OH, October 21, 1994.

Theken, R.R.: Technical Report 112594-003. Submitted to AcroMed Corporation, Cleveland, OH, November 25, 1994.

Theken, R.R.: Technical Report 121894-004. Submitted to AcroMed Corporation, Cleveland, OH, December 18, 1994.

Theken, R.R. Technical Report 022895-005. Submitted to AcroMed Corporation, Cleveland, OH, February 28, 1995.

Theken, R.R. Technical Report 022895-006. Submitted to AcroMed Corporation, Cleveland, OH, February 28, 1995. 

Theken, R.R. Technical Report 031595-007. Submitted to AcroMed Corporation, Cleveland, OH, March 15, 1995.

Theken, R.R. Technical Report 050895-008. Submitted to AcroMed Corporation, Cleveland, OH, May 8, 1995.

Theken, R.R. Technical Report 050995-009. Submitted to AcroMed Corporation, Cleveland, OH, May 9, 1995.

Theken, R.R. Technical Report 073095-010. Submitted to AcroMed Corporation, Cleveland, OH, July 30, 1995.

Theken, R.R. Technical Report 092595-012. Submitted to AcroMed Corporation, Cleveland, OH, September 25, 1995.

Theken, R.R. Technical Report 101695-013. Submitted to AcroMed Corporation, Cleveland, OH, October 16, 1995.

Theken, R.R. Technical Report 022896-014. Submitted to AcroMed Corporation, Cleveland, OH, March 11, 1996.

Theken, R.R. Technical Report 041096-015. Submitted to AcroMed Corporation, Cleveland, OH, June 7, 1996.

Theken, R.R. Technical Report 043096-016. Submitted to AcroMed Corporation, Cleveland, OH, July 8, 1996.

Theken, R.R. Technical Report 063096-017. Submitted to AcroMed Corporation, Cleveland, OH, June 6, 1996.

Theken, R.R. Technical Report 062096-018. Submitted to AcroMed Corporation, Cleveland, OH, June 21, 1996.

Theken, R.R. Technical Report 102196-019. Submitted to AcroMed Corporation, Cleveland, OH, October 21, 1996.

Theken, R.R. Technical Report 012897-020. Submitted to AcroMed Corporation, Cleveland, OH, January 29, 1997.

Theken, R.R. Technical Report 030597-021. Submitted to AcroMed Corporation, Cleveland, OH, March 6, 1997.

Theken, R.R. Technical Report 062497-022. Submitted to AcroMed Corporation, Cleveland, OH, June 24, 1997.

Theken, R.R. Technical Report 062795-001. Submitted to Advanced Spine Fixation Systems, Cypress, CA, June 27, 1995.

Theken, R.R. Technical Report 071395-002. Submitted to Advanced Spine Fixation Systems, Cypress, CA, July 13, 1995.

Theken, R.R. Technical Report 101095-003. Submitted to Advanced Spine Fixation Systems, Cypress, CA, October 10, 1995.

Theken, R.R. Technical Report 051596-004. Submitted to Advanced Spine Fixation Systems, Cypress, CA, May 15, 1996.

Theken, R.R. Technical Report 072996-005. Submitted to Advanced Spine Fixation Systems, Cypress, CA, July 29, 1996.

Theken, R.R. Technical Report 082297-007. Submitted to Advanced Spine Fixation Systems, Cypress, CA, October 12, 1997.

Theken, R.R.: Technical Report 120594-001. Submitted to Applied Osteo Systems, Inc., Walnut Creek, CA, December 5, 1994.

Theken, R.R. Technical Report 032495-002. Submitted to Applied Osteo Systems, Inc., Walnut Creek, CA, March 24, 1995.

Theken, R.R. Technical Report 041595-003. Submitted to Applied Osteo Systems, Inc., Walnut Creek, CA, April 5, 1995.

Theken, R.R. Technical Report 053095-004. Submitted to Applied Osteo Systems, Inc., Walnut Creek, CA, May 30, 1995.

Theken, R.R. Technical Report 080895-005. Submitted to Applied Osteo Systems, Inc., Walnut Creek, CA, August 8, 1995.

Theken, R.R.: Technical Report 112594-001. Submitted to Ashland Chemical Corporation, Columbus, OH, November 25, 1994.

Theken, R.R. Technical Report 012797-002. Submitted to CO-LIGNE AG, Zuerich, Sweeden, January 27, 1997.

Theken, R.R. Technical Report 030997-003. Submitted to CO-LIGNE AG, Zuerich, Sweeden, March 7, 1997.

Theken, R.R. Technical Report 030997-004. Submitted to CO-LIGNE AG, Zuerich, Sweeden, March 7, 1997.

Theken, R.R. Technical Report 042797-005. Submitted to CO-LIGNE AG, Zuerich, Sweeden, April 2, 1997.

Theken, R.R.: Technical Report 111892-001. Submitted to Cross Medical Products, Columbus, OH, November 18, 1992.

Theken, R.R.: Technical Report 062193-004. Submitted to Cross Medical Products, Columbus, OH, June 21, 1993.

Theken, R.R.: Technical Report 021294-005. Submitted to Cross Medical Products, Columbus, OH, February 12, 1994.

Theken, R.R.: Technical Report 053194-006. Submitted to Cross Medical Products, Columbus, OH, September 30, 1994.

Theken, R.R.: Technical Report 020695-007. Submitted to Cross Medical Products, Columbus, OH, February 6, 1995.

Theken, R.R. Technical Report 101995-001. Submitted to Depuy Incorporated, Warsaw, IN, October 19, 1995.

Theken, R.R. Technical Report 071296-002. Submitted to Depuy Incorporated, Warsaw, IN, July 12, 1996.

Theken, R.R. Technical Report 012097-003. Submitted to Depuy Incorporated, Warsaw, IN, January 20, 1997.

Theken, R.R. Technical Report 052197-004. Submitted to Depuy Incorporated, Warsaw, IN, May 21, 1997.

Theken, R.R. Technical Report 101297-005. Submitted to Depuy Incorporated, Warsaw, IN, October 12, 1997.

Theken, R.R. Technical Report 103197-006. Submitted to Depuy Incorporated, Warsaw, IN, October 31, 1997.

Theken, R.R. Technical Report 101297-007. Submitted to Depuy Incorporated, Warsaw, IN, October 12, 1997.

Theken, R.R. Technical Report 100195-001. Submitted to Exactech, Inc., Gainesville, FL, September 30, 1995.

Theken, R.R. Technical Report 032596-002. Submitted to Exactech, Inc., Gainesville, FL, March 25, 1996.

Theken, R.R. Technical Report 102596-003. Submitted to Exactech, Inc., Gainesville, FL, October 25, 1996.

Theken, R.R. Technical Report 031896-001. Submitted to Genesis Orthopedics, Inc., Cambridge, MA, March 18, 1996.

Theken, R.R. Technical Report 101496-002. Submitted to Genesis Orthopedics, Inc., Cambridge, MA, October 14, 1996.

Theken, R.R. Technical Report 101496-003. Submitted to Genesis Orthopedics, Inc., Cambridge, MA, October 14, 1996.

Theken, R.R. Technical Report 040697-004. Submitted to Genesis Orthopedics, Inc., Cambridge, MA, April 6, 1997.

Theken, R.R. Technical Report 082495-001. Submitted to Joint Medical Products Corporation, Stamford, CT, August 24, 1995.

Theken, R.R. Technical Report 101795-002. Submitted to Joint Medical Products Corporation, Stamford, CT, October 17, 1995.

Theken, R.R. Technical Report 120295-003. Submitted to Johnson and Johnson Professional Inc., Stamford, CT, December 5, 1995.

Theken, R.R. Technical Report 120295-004. Submitted to Johnson and Johnson Professional Inc., Stamford, CT, December 5, 1995.

Theken, R.R. Technical Report 050896-005. Submitted to Johnson and Johnson Professional Inc., Stamford, CT, May 8, 1996.

Theken, R.R. Technical Report 081695-001. Submitted to Mitek Surgical Products, Inc., Westwood, MA, August 16, 1995.

Theken, R.R. Technical Report 091195-002. Submitted to Mitek Surgical Products, Inc., Westwood, MA, September 11, 1995.

Theken, R.R. Technical Report 062796-001. Submitted to Osteotech Inc., Eatontown, NJ, June 27, 1996.

Theken, R.R. Technical Report 070196-002. Submitted to Osteotech Inc., Eatontown, NJ, July 1, 1996.

Theken, R.R. Technical Report 070897-003. Submitted to Osteotech Inc., Eatontown, NJ, July 8, 1997.

Theken, R.R. Technical Report 011096-001. Submitted to Smith & Nephew Richards, Inc., Memphis, TN, January 10, 1996.

Theken, R.R. Technical Report 101596-001. Submitted to Sofamor Danek Group, Memphis, TN, October 17, 1996.

Theken, R.R. Technical Report 111896-003. Submitted to Sofamor Danek Group, Memphis, TN, November 18, 1996.

Theken, R.R. Technical Report 110396-004. Submitted to Sofamor Danek Group, Memphis, TN, December 3, 1996.

Theken, R.R. Technical Report 010397-005. Submitted to Sofamor Danek Group, Memphis, TN, January 6, 1997.

Theken, R.R. Technical Report 020397-006. Submitted to Sofamor Danek Group, Memphis, TN, February 3, 1997.

Theken, R.R. Technical Report 021897-007. Submitted to Sofamor Danek Group, Memphis, TN, February 18, 1997.

Theken, R.R. Technical Report 033197-008. Submitted to Sofamor Danek Group, Memphis, TN, March 31, 1997.

Theken, R.R. Technical Report 031097-009. Submitted to Sofamor Danek Group, Memphis, TN, March 10, 1997.

Theken, R.R. Technical Report 032397-010. Submitted to Sofamor Danek Group, Memphis, TN, March 23, 1997.

Theken, R.R. Technical Report 051397-011. Submitted to Sofamor Danek Group, Memphis, TN, May 13, 1997.

Theken, R.R. Technical Report 042997-012. Submitted to Sofamor Danek Group, Memphis, TN, April 29, 1997.

Theken, R.R. Technical Report 051997-013. Submitted to Sofamor Danek Group, Memphis, TN, May 19, 1997.

Theken, R.R. Technical Report 061897-018. Submitted to Sofamor Danek Group, Memphis, TN, June 18, 1997.

Theken, R.R. Technical Report 062397-015. Submitted to Sofamor Danek Group, Memphis, TN, June 25, 1997.

Theken, R.R. Technical Report 082997-016. Submitted to Sofamor Danek Group, Memphis, TN, August 29, 1997.

Theken, R.R. Technical Report 072897-017. Submitted to Sofamor Danek Group, Memphis, TN, July 29, 1997.

Theken, R.R. Technical Report 072897-018. Submitted to Sofamor Danek Group, Memphis, TN, July 29, 1997.

Theken, R.R. Technical Report 110697-019. Submitted to Sofamor Danek Group, Memphis, TN, November 6, 1997.

Theken, R.R. Technical Report 120397-020. Submitted to Sofamor Danek Group, Memphis, TN, November 19, 1997.

Theken, R.R. Technical Report 091195-001. Submitted to Wright Medical Technology, Inc., Arlington, TN, September 8, 1995.

Theken, R.R. Technical Report 061397-002. Submitted to Wright Medical Technology, Inc., Arlington, TN, June 13, 1997.

Theken, R.R. Technical Report 121895-001. Submitted to Zimmer, Warsaw, IN, December 18, 1995.


Patents

Patent Number: 5556092, Issued Sep. 17, 1996  "Ergonomic Handle for Use With Medical Instrumentation."

Patent Number: D377895Issued Feb. 11, 1997  "Ergonomic Handle for Use With Medical Instrumentation."

Patent Number: 6228085, Issued May 8, 2001  "Bone Fixation System"

Patent Number: 6342055, Issued January 29, 2002  "Bone Fixation System"

Patent Number: 7001389Issued July 5, 2002  "Self-Locking Set Screw for Spinal Fixation System."

Patent Number: 7278997Issued October 9, 2007  "Instrument Guide and Implant Holder"

Patent Number: 7491209, Issued February 17, 2009  "Instrument Guide and Implant Holder"

Patent Number: 7763075, Issued July 27, 2010  "Artificial Disc Prosthesis"

Patent Number: 7763076 Issued July 27, 2010 "Artificial Disc Prosthesis"

Patent Number: 7766911 , Issued August 3, 2010  "Fixed and Variable Locking Fixation Assembly"

Patent Number: 7771478, Issued August 10, 2010  "Artificial Disc Prosthesis"

Patent Number: 7771480,  Issued August 10, 2010  "Artificial Disc Prosthesis"

Patent Number: 7780666Issued August 24, 2010   "Fixed and Variable Locking Fixation Assembly"

Patent Number: 7785327Issued August 31, 2010  "Fixed and Variable Locking Fixation Assembly"

Patent Number: 7806935, Issued October 5, 2010  "Artificial Disc Prosthesis"