b-ONE™ Primary Acetabular System

FDA UDI

Class II (US FDA UDI)

by b-ONE Ortho Corp.

Identity

Trade Name: b-ONE™ Primary Acetabular System FDA UDI
Generic Name: Metallic acetabulum prosthesis FDA UDI
Device Name: Cementless Acetabular Shell, Cluster Hole; Porous Plasma Spray + HA Coating; 54mm Outer Diameter, Liner Size H FDA UDI
Model / Reference: 881311541H FDA UDI
Description: Cementless Acetabular Shell, Cluster Hole; Porous Plasma Spray + HA Coating; 54mm Outer Diameter, Liner Size H FDA UDI

Identifiers

Catalog Number: 881311541H FDA UDI
Primary DI / UDI-DI: 00843575103550 FDA UDI
FDA Product Code: MEH FDA UDI
HWC FDA UDI
LZO FDA UDI
GMDN Term: Metallic acetabulum prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3040 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: Metallic acetabulum prosthesis

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

Similar devices

Also classified as Metallic acetabulum prosthesis.

TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc. · Class II
Lineage — MicroPort Orthopedics Inc. · Class II
Lineage — MicroPort Orthopedics Inc. · Class II
Dynasty — MicroPort Orthopedics Inc. · Class II
Platform Acetabular Cup with Ti-Coat — TOTAL JOINT ORTHOPEDICS, INC. · Class II
PRIME — MicroPort Orthopedics Inc. · Class II
PROCOTYL® PRIME — MicroPort Orthopedics Inc. · Class II
Lineage — MicroPort Orthopedics Inc. · 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 b5984101-1cb0-4df5-a105-890ab7a415ff 34 fields · synced Jun 8, 2026