MOBIO™ Total Knee System

FDA UDI

Class II (US FDA UDI)

by b-ONE Ortho Corp.

Identity

Trade Name: MOBIO™ Total Knee System FDA UDI
Generic Name: Cruciate-retaining total knee prosthesis FDA UDI
Device Name: CR Tibial Insert, Vitamin E UHMWPE, Size BC/1-6, 11 mm FDA UDI
Model / Reference: 8821323111 FDA UDI
Description: CR Tibial Insert, Vitamin E UHMWPE, Size BC/1-6, 11 mm FDA UDI

Identifiers

Catalog Number: 8821323111 FDA UDI
Primary DI / UDI-DI: 00843575109064 FDA UDI
FDA Product Code: JWH FDA UDI
OIY FDA UDI
GMDN Term: Cruciate-retaining total knee prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cruciate-retaining total knee prosthesis

MOBIO™ Total Knee System by b-ONE Ortho Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cruciate-retaining total knee prosthesis.

Arthrex® — Arthrex, Inc. · Class II
Columbus® UC — AESCULAP, INC. · Class II
Optimotion Blue CR HCCR Total Knee System — OPTIMOTION IMPLANTS, LLC · Class II
UKNEE Tibial insert, plained — UNITED ORTHOPEDIC CORP. · Class II
B-P TOTAL KNEE SYSTEM — ENDOTEC, INC. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: b-ONE Ortho Corp.

Sources (1)

FDA UDI 77d35193-7c96-4360-b440-f04959f2a2b1 34 fields · synced May 31, 2026