Cleared Traditional

NextStep Arthropedix Total Knee System (K242410) - FDA 510(k) Clearance

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

K242410 · Nextstep Arthropedix · Orthopedic device
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May 2025
Decision
267d
Days
Class 2
Risk

K242410 is an FDA 510(k) clearance for the NextStep Arthropedix Total Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Nextstep Arthropedix (Akron, US). The FDA issued a Cleared decision on May 8, 2025 after a review of 267 days - an extended review 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: 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 Nextstep Arthropedix devices

Submission Details

510(k) Number K242410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2024
Decision Date May 08, 2025
Days to Decision 267 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
145d slower than avg
Panel avg: 122d · This submission: 267d
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 523
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K242410.
EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)
K251776 · Encore Medical, L.P. · Jul 2025
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K251241 · Encore Medical, L.P. · Jul 2025
Freedom® Total Knee System – Titanium Tibial Base Plate
K251717 · Maxx Orthopedics, Inc. · Jun 2025
EXULT Knee Replacement System
K250889 · Corentec Co., Ltd. · Apr 2025
LEGION Total Knee System
K250677 · Smith & Nephew, Inc. · Apr 2025
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K243991 · Total Joint Othopedics, Inc. · Mar 2025