DISCOVERY ELBOW— 510(k) K013042

Clearance details

Applicant

Biomet Orthopedics, Inc.

Product code

Code JDC

Device class

Class 2

Regulation

21 CFR 888.3150

Advisory panel

Orthopedic

Date received

2001-09-10

Decision date

2001-10-10

Decision

Substantially Equivalent

Clearance type

Special

Location

Warsaw, IN, US

• K181362 — TEMA Elbow System2019-02-16
• K181307 — Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow2019-01-28
• K153398 — Comprehensive SRS/Nexel Elbow2016-02-03
• K150501 — Zimmer Nexel Total Elbow Ulnar Cement Diverter2015-04-23
• K123862 — ZIMMER NEXEL TOTAL ELBOW2013-03-12

• K253515 — Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments2026-08-24
• K080528 — E-POLY TIBIAL BEARINGS2008-06-17
• K072879 — INNERVUE DIAGNOSTIC SCOPE SYSTEM2008-01-14
• K070955 — ACID ETCHED LAG SCREWS2007-10-12
• K033355 — LACTOSCREW SCREW ANCHOR2004-06-30

Injury

1,050

Total

1,050

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1925-2014 — DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.Class II·Terminated·Biomet, Inc.·20140515

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013042.