Stryker ADM® X3 Anatomic Dual Mobility Acetabular System. Catalog #1235-2-461

Vendor/Manufacturer: Stryker

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

Vendor/Manufacturer Catalog #: 1235-2-461

Global Unique Device (GUD) Primary Device Identifier Number: 04546540665867

Global Unique Device (GUD) Device Description:

ADM Shell, Right

Global Medical Device Nomenclature (GMDN) Preferred Term Name: Acetabular shell Global Medical Device Nomenclature (GMDN) Definition: An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

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): JDI, KWL, KWY, KWZ, LPH, LWJ, LZO, MAY, MBL, MEH

FDA Classification Product Code Device Name(s):

JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

KWL: Prosthesis, hip, hemi-, femoral, metal

KWY: Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

KWZ: Prosthesis, hip, constrained, cemented or uncemented, metal/polymer

LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

LWJ: Prosthesis, hip, semi-constrained, metal/polymer, uncemented

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

MAY: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish

MBL: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous

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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