Cleared Traditional

K211221 - Porous Patella and Porous Tibia Baseplate

K211221 is the FDA 510(k) clearance for Porous Patella and Porous Tibia Baseplate by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code MBH) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K211221 · Smith & Nephew, Inc. · Orthopedic device
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Oct 2021
Decision
161d
Days
Class 2
Risk

K211221 is an FDA 510(k) clearance for the Porous Patella and Porous Tibia Baseplate. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on October 1, 2021 after a review of 161 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K211221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2021
Decision Date October 01, 2021
Days to Decision 161 days
Submission Type Traditional
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
39d slower than avg
Panel avg: 122d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 123
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K211221.
Porous Patella
K212941 · Encore Medical, L.P. Dba Djo Surgical · Jan 2022
ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP
K213781 · Depuy Ireland UC · Jan 2022
MPO Knee Instruments
K213817 · Microport Orthopedics, Inc. · Jan 2022
Symmetric Total Knee System
K203779 · Signal Medical Corporation · Jun 2021
LEGION CR Porous Plus HA Femoral Components
K211246 · Smith & Nephew, Inc. · May 2021
Physica system
K210554 · Lima Corporate S.P.A. · Apr 2021