OFFSET TIBIAL TRAY— 510(k) K010212

Clearance details

Applicant

Biomet, Inc.

Product code

Code MBV

Device class

Class 2

Regulation

21 CFR 888.3560

Advisory panel

Orthopedic

Date received

2001-01-23

Decision date

2001-02-14

Decision

Substantially Equivalent

Clearance type

Special

Location

Warsaw, IN, US

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• Z-2177-2018 — Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee ArthroplastyClass II·Terminated·Zimmer Biomet, Inc.·20180518
• Z-0533-2013 — Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both primary and revision applications. Indications: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis when one or more compartments are involved, 2) correction of varus, valgus, or posttraumatic deformity, 3) correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedureClass II·Terminated·Biomet, Inc.·20121115

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010212.