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510(k) K013042

DISCOVERY ELBOW by Biomet Orthopedics, Inc. — Product Code JDC

K013042 is an FDA 510(k) premarket notification submitted by Biomet Orthopedics, Inc. for the device "DISCOVERY ELBOW". The FDA issued a decision of Substantially Equivalent on October 10, 2001. The device falls under product code JDC (Prosthesis, Elbow, Constrained, Cemented), a Class II device regulated under 21 CFR 888.3150. Biomet Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2001
Date Received
September 10, 2001
Clearance Type
Special
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 Biomet Orthopedics, Inc.

  • K252404 — Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (April 15, 2026)
  • K243761 — A.L.P.S. Small Fragment Plating System (February 19, 2025)
  • K223631 — Comprehensive Segmental Revision System(SRS) (July 12, 2023)
  • K200196 — Taperloc® Complete Hip Stems (December 8, 2020)
  • K131393 — MAK OSS FEMORAL KNEE COMPONENTS (October 24, 2013)
  • K112905 — COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM (May 24, 2012)
  • K080528 — E-POLY TIBIAL BEARINGS (June 17, 2008)
  • K072879 — INNERVUE DIAGNOSTIC SCOPE SYSTEM (January 14, 2008)
  • K070955 — ACID ETCHED LAG SCREWS (October 12, 2007)
  • K033355 — LACTOSCREW SCREW ANCHOR (June 30, 2004)

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