Stryker ADM® X3 Anatomic Dual Mobility Acetabular System. Catalog #1236-2-846

Vendor/Manufacturer: Stryker

Product/Product Line: ADM® X3 Anatomic Dual Mobility Acetabular System

Vendor/Manufacturer Catalog #: 1236-2-846

Global Unique Device (GUD) Primary Device Identifier Number: 04546540665904

Global Unique Device (GUD) Device Description:

ADM / MD X3 Insert

Global Medical Device Nomenclature (GMDN) Preferred Term Name: Non-constrained polyethylene acetabular liner Global Medical Device Nomenclature (GMDN) Definition: A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices FDA Regulation Number: 888.3358

FDA Regulation Description Classification Name:

Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis

FDA Classification Product Code(s): LZO, MEH

FDA Classification Product Code Device Name(s):

LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

FDA Premarket Submission(s): K103233 , K093644 , K182468 , K151264 , K142462 , K210893 The Stryker ADM® X3 Anatomic Dual Mobility Acetabular System is

SUBSTANTIALLY EQUIVALENT to the following product(s): 1. Restoration® ADM System

2. Restoration® X3® Acetabular Insert

3. Trident® Porous Titanium Acetabular Component

4. Trident® X3® Acetabular Inserts

5. Trident Porous Titanium Acetabular Shell

6. Restoration ADM® and MDM® X3® Acetabular Inserts

7. Restoration Anatomic Shell

8. S-ROM Oblong Cup

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