Cleared Special

K010212 - OFFSET TIBIAL TRAY

K010212 is the FDA 510(k) clearance for OFFSET TIBIAL TRAY by Biomet, Inc.. It is a Class 2 Orthopedic device (product code MBV) cleared through the Special 510(k) pathway after a 22-day FDA review.

K010212 · Biomet, Inc. · Orthopedic device
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Feb 2001
Decision
22d
Days
Class 2
Risk

K010212 is an FDA 510(k) clearance for the OFFSET TIBIAL TRAY. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer (product code MBV), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 14, 2001 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomet, Inc. devices

Submission Details

510(k) Number K010212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MBV Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MBV Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer

All 9
Devices cleared under the same product code (MBV) and FDA review panel - the closest regulatory comparables to K010212.
TRICON-M TOTAL KNEE SYSTEM
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TRICON M TOTAL KNEE SYSTEM
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POROCOAT FREEMAN/SAMUELSON TOTAL KNEE
K831441 · Depuy, Inc. · Sep 1983
RMC TOTAL KNEE SYSTEM
K823837 · Richard'S Medical Equip., Inc. · Mar 1983
FREEMAN/SAMUELSON TOTAL KNEE
K830408 · Depuy, Inc. · Feb 1983
TOTAL KNEE SYSTEM
K822583 · Richard'S Medical Equip., Inc. · Oct 1982