Cleared Traditional

K212941 - Porous Patella

K212941 is an FDA 510(k) clearance for Porous Patella, manufactured by Encore Medical, L.P. Dba Djo Surgical. The device is a Class 2 Orthopedic device with 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K212941

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.

MBH Device Classification - Class 2, Special Controls

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 141
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