Cleared Special

K010212 - OFFSET TIBIAL TRAY

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

K010212 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K010212

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.

MBV Device Classification - Class 2, Special Controls

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 13
Devices cleared under the same product code (MBV) and FDA review panel - the closest regulatory comparables to K010212.
TRICON-M TOTAL KNEE SYSTEM
K884824 · Richards Medical Co., Inc. · Nov 1989
FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE
K873429 · Protek, Inc. · Oct 1987
FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP
K853730 · Protek, Inc. · Feb 1986
TRICON M TOTAL KNEE SYSTEM
K833200 · Richards Medical Co., Inc. · Nov 1983
POROCOAT FREEMAN/SAMUELSON TOTAL KNEE
K831441 · Depuy, Inc. · Sep 1983
MARK I TOTAL KNEE SYS. ARTHROPLASTY
K832302 · Advanced Biosearch Assn. · Aug 1983