Cleared Traditional

K223316 - Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223316 · Conformis, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2023
Decision
266d
Days
Class 2
Risk

K223316 is an FDA 510(k) clearance for the Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porou.... Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Conformis, Inc. (Billerica, US). The FDA issued a Cleared decision on July 21, 2023 after a review of 266 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 Conformis, Inc. devices

Submission Details

510(k) Number K223316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2022
Decision Date July 21, 2023
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
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 141
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K223316.
Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
K253189 · Zimmer, Inc. · Mar 2026
GMK 3D Metal Tibial Tray Extension
K253328 · Medacta International S.A. · Feb 2026
Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
K253637 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Feb 2026
Active-V Total Knee System
K253239 · Signature Orthopaedics Pty, Ltd. · Dec 2025
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K253161 · Ortho Development Corp. · Dec 2025
Freedom Metaphyseal Cone Implants (Metaphyseal Cones)
K252777 · Maxx Orthopedics, Inc. · Oct 2025