Cleared Special

OFFSET TIBIAL TRAY

K010212 · Biomet, Inc. · Orthopedic

Feb 2001

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K010212 is an FDA 510(k) clearance for the OFFSET TIBIAL TRAY, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code MBV), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 14, 2001, 22 days after receiving the submission on January 23, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K010212 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 2001
Decision Date	February 14, 2001
Days to Decision	22 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBV — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560