Cleared Traditional

K262341 - b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions

K262341 is an FDA 510(k) clearance for b-ONE Mobio Total Knee System Revision ..., manufactured by B-One Ortho, Corp.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K262341 · B-One Ortho, Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
60d
Days
Class 2
Risk

K262341 is an FDA 510(k) clearance for the b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Exten.... Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by B-One Ortho, Corp. (Cedar Knolls, US). The FDA issued a Cleared decision on September 8, 2026 after a review of 60 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 B-One Ortho, Corp. devices

FDA 510(k) Submission Details - K262341

510(k) Number K262341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2026
Decision Date September 08, 2026
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 908
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K262341.
GMK Extension
K262057 · Medacta International, SA · Sep 2026
GSPE Spacer
K260063 · The General Hospital Corporation, d/b/a Massachusetts · Sep 2026
EVOLUTION MPX™ Total Knee System
K262293 · Suzhou Microport Orthorecon Co., Ltd. · Sep 2026
ATTUNE Revision Knee System
K262130 · DePuy Orthopaedics, Inc. · Sep 2026
SK Knee System
K253961 · Just Medical Devices (Tianjin) Co., Ltd. · Sep 2026
Freedom Total Knee System (E-Poly Tibial Liners)
K261563 · Maxx Orthopedics, Inc. · Aug 2026