Mpact 3D Metal Augments II

Basic Information

• Brand Name: Mpact 3D Metal Augments II
• Primary DI: 07630542700507
• Version / Model: 01.38.54815
• Company Name: Medacta International SA
• Labeler DUNS: 488227125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-01
• Public Version: 1
• Public Version Date: 2025-05-09
• Public Version Status: New
• Public Device Record Key: 7be7c439-6b98-4473-903e-1ea591336ac2

Device Description

Augments II Ø48 15mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	Orthopedic	888.3358	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61780	Acetabular augmentation implant	A sterile implantable device intended to help prevent dislocation of a total hip replacement by augmenting the posterior lip of the acetabulum around a retained acetabular prosthesis, or to help fill bone defects not covered by the acetabular prosthesis. It is designed to help constrain the femoral head and/or provide additional support for the acetabular prosthesis. It is available in various shapes, is typically made of metal [e.g. Titanium alloy] and/or polymer, and may be fixed with screws and/or cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630542700507	GS1

Premarket Submissions

Submission Number	Supplement Number
K242232	000