510(k) K242410

NextStep Arthropedix Total Knee System by Nextstep Arthropedix — Product Code JWH

K242410 is an FDA 510(k) premarket notification submitted by Nextstep Arthropedix for the device "NextStep Arthropedix Total Knee System". The FDA issued a decision of Substantially Equivalent on May 8, 2025. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Nextstep Arthropedix has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2025
Date Received
August 14, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type