Cleared Traditional

K212941 - Porous Patella

K212941 is the FDA 510(k) clearance for Porous Patella by Encore Medical, L.P. Dba Djo Surgical. It is a Class 2 Orthopedic device (product code MBH) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K212941 · Encore Medical, L.P. Dba Djo Surgical · Orthopedic device
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Jan 2022
Decision
127d
Days
Class 2
Risk

K212941 is an FDA 510(k) clearance for the Porous Patella. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Encore Medical, L.P. Dba Djo Surgical (Austin, US). The FDA issued a Cleared decision on January 20, 2022 after a review of 127 days - within the typical 510(k) review window.

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 Encore Medical, L.P. Dba Djo Surgical devices

Submission Details

510(k) Number K212941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2021
Decision Date January 20, 2022
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
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 K212941.
Zimmer Persona Personalized Knee System
K222566 · Zimmer, Inc. · Oct 2022
GMK 3D Metal Tibial Tray
K221850 · Medacta International S.A. · Aug 2022
Optimotion Implants Porous Metal-Backed Patella
K220049 · Optimotion Implants, LLC · Mar 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
Porous Patella and Porous Tibia Baseplate
K211221 · Smith & Nephew, Inc. · Oct 2021