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510(k) K955916

TOWNLEY TOTAL ELBOW SYSTEM by Biologically Oriented Prostheses — Product Code JDC

K955916 is an FDA 510(k) premarket notification submitted by Biologically Oriented Prostheses for the device "TOWNLEY TOTAL ELBOW SYSTEM". The FDA issued a decision of Substantially Equivalent on August 8, 1996. The device falls under product code JDC (Prosthesis, Elbow, Constrained, Cemented), a Class II device regulated under 21 CFR 888.3150. Biologically Oriented Prostheses has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1996
Date Received
December 29, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Constrained, Cemented
Device Class
Class II
Regulation Number
888.3150
Review Panel
OR
Submission Type

Other clearances by Biologically Oriented Prostheses

  • K002325 — WUJIN #3 TIBIAL NAIL (October 30, 2000)
  • K992144 — BIOPRO RIMMED ACETABULAR COMPOMENT (September 22, 1999)
  • K964472 — RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT (February 3, 1997)
  • K962769 — HORIZON HIP SYSTEM (October 3, 1996)
  • K954768 — BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD (January 18, 1996)
  • K952731 — TOWNLEY ALL POLY ACETABULAR CUP (December 28, 1995)
  • K953045 — BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD (September 27, 1995)
  • K951356 — VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED (June 19, 1995)

Other clearances for product code JDC

  • K181362 — TEMA Elbow System (February 16, 2019)
  • K181307 — Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow (January 28, 2019)
  • K153398 — Comprehensive SRS/Nexel Elbow (February 3, 2016)
  • K150501 — Zimmer Nexel Total Elbow Ulnar Cement Diverter (April 23, 2015)
  • K123862 — ZIMMER NEXEL TOTAL ELBOW (March 12, 2013)
  • K090473 — DISCOVERY ELBOW - X-SMALL (March 25, 2009)
  • K060696 — ACCLAIM TOTAL ELBOW SYSTEM (April 14, 2006)
  • K053189 — COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES (December 9, 2005)
  • K051975 — POROUS COATED DISCOVERY ELBOW (September 6, 2005)
  • K042664 — LPS UPPER EXTREMITY (December 8, 2004)

FDA data resources