Mpact 3D Metal

FDA UDI

Class II (US FDA UDI)

by Medacta International

Identity

Trade Name: Mpact 3D Metal FDA UDI
Generic Name: Metallic acetabulum prosthesis FDA UDI
Device Name: Augments 70/72 15mm FDA UDI
Model / Reference: 01.38.116 FDA UDI
Description: Augments 70/72 15mm FDA UDI

Identifiers

Primary DI / UDI-DI: 07630030889134 FDA UDI
510(k) Number: K171966 FDA UDI
FDA Product Code: LPH FDA UDI
GMDN Term: Metallic acetabulum prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Category: Metallic acetabulum prosthesis

The Mpact 3D Metal device is a cutting-edge, sterile implantable principal component of a total hip prosthesis designed to replace or repair the acetabulum. Augmenting the success of joint replacement surgeries with its one-piece construction and metal composition, this device offers unparalleled accuracy and reliability in orthopedic procedures.

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

Cleared under the same submission

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: Medacta International

Sources (1)

FDA UDI 680b42de-2b71-4931-98f9-da6c0a8d0bd3 34 fields · synced Jul 31, 2026