Platform Acetabular Cup with Ti-Coat

FDA UDI

Class II (US FDA UDI)

by Total Joint Orthopedics, Inc.

Identity

Trade Name: Platform Acetabular Cup with Ti-Coat FDA UDI
Generic Name: Metallic acetabulum prosthesis FDA UDI
Device Name: Acetabular Cup with Ti-Coat, size 62mm FDA UDI
Model / Reference: 3401.62.000 FDA UDI
Description: Acetabular Cup with Ti-Coat, size 62mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00814703017469 FDA UDI
510(k) Number: K220483 FDA UDI
FDA Product Code: LZO FDA UDI
MBL FDA UDI
LPH FDA UDI
GMDN Term: Metallic acetabulum prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3358 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

Sterilization Method

Radiation Sterilization FDA UDI

Category: Metallic acetabulum prosthesis

Platform Acetabular Cup with Ti-Coat by Total Joint Orthopedics, Inc. — 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
PRIME — MicroPort Orthopedics Inc. · Class II
PROCOTYL® PRIME — MicroPort Orthopedics Inc. · Class II
Lineage — MicroPort Orthopedics Inc. · Class II
b-ONE™ Primary Acetabular System — b-ONE Ortho Corp. · Class II

Cleared under the same submission

K220483 also covers:

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: Total Joint Orthopedics, Inc.

Sources (1)

FDA UDI 61e1a431-8b4a-44bc-b7a8-2812cf4f8b92 37 fields · synced Jun 8, 2026