Cleared Traditional

K221404 - Identity Imprint Knee Replacement Syste...

K221404 is the FDA 510(k) clearance for Identity Imprint Knee Replacement Syste... by Conformis, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K221404 · Conformis, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
71d
Days
Class 2
Risk

K221404 is an FDA 510(k) clearance for the Identity Imprint Knee Replacement System (including Identity Imprint Posterio.... Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Conformis, Inc. (Billerica, US). The FDA issued a Cleared decision on July 26, 2022 after a review of 71 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Conformis, Inc. devices

Submission Details

510(k) Number K221404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2022
Decision Date July 26, 2022
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, 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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 772
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K221404.
Tibial baseplate, Tibial insert
K222700 · United Orthopedic Corporation · Oct 2022
TriVerse Total Knee Replacement System
K222380 · Signature Orthopaedics Pty, Ltd. · Oct 2022
LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation
K222278 · Corentec Co., Ltd. · Aug 2022
Cemented Round Patella with JRNY Pegs
K221939 · Smith & Nephew, Inc. · Jul 2022
Materialise TKA Guide System
K221337 · Materialise NV · Jul 2022
Klassic Knee System
K211877 · Total Joint Orthopedics, Inc. · Jun 2022