Cleared Special

K221939 - Cemented Round Patella with JRNY Pegs

K221939 is an FDA 510(k) clearance for Cemented Round Patella with JRNY Pegs, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Special 510(k) pathway after a 25-day FDA review.

K221939 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
25d
Days
Class 2
Risk

K221939 is an FDA 510(k) clearance for the Cemented Round Patella with JRNY Pegs. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on July 26, 2022 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K221939

510(k) Number K221939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2022
Decision Date July 26, 2022
Days to Decision 25 days
Submission Type Special
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
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

JWH Device Classification - Class 2, Special Controls

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 921
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K221939.
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
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
K221404 · Conformis, Inc. · Jul 2022
Materialise TKA Guide System
K221337 · Materialise NV · Jul 2022
Klassic Knee System
K211877 · Total Joint Orthopedics, Inc. · Jun 2022
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
K221059 · Conformis, Inc. · May 2022
K221939 · Cemented Round Patella with JRNY Pegs
Download PDF FDA Summary Smith & Nephew, Inc.