Cleared Traditional

b-ONE MOBIO Total Knee System (K213673) - FDA 510(k) Clearance

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

K213673 · B-One Ortho, Corp. · Orthopedic device
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Jan 2022
Decision
60d
Days
Class 2
Risk

K213673 is an FDA 510(k) clearance for the b-ONE MOBIO Total Knee System. 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 January 21, 2022 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

Submission Details

510(k) Number K213673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2021
Decision Date January 21, 2022
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.

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 K213673.
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World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC)
K220737 · Signature Orthopaedics Pty, Ltd. · Apr 2022
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K213793 · Encore Medical, L.P. · Apr 2022
Physica system
K213381 · Lima Corporate S.P.A. · Dec 2021
LOSPA TKR System
K212034 · Corentec Co., Ltd. · Dec 2021
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K212839 · Meril Healthcare Pvt. , Ltd. · Nov 2021