EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System

FDA 510(k)

FDA Class 2 ·Orthopedic

Prime Acetabular Cup System

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell

FDA 510(k)

FDA Class 2 ·Orthopedic

EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base

FDA 510(k)

FDA Class 2 ·Orthopedic

EVOLUTION Stemmed CS Femur

FDA 510(k)

FDA Class 2 ·Orthopedic

PROFEMUR Preserve Size 1-3 Hip Stems

FDA 510(k)

FDA Class 2 ·Orthopedic

PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar

FDA 510(k)

FDA Class 2 ·Orthopedic

PROFEMUR TL2 Stems

FDA 510(k)

FDA Class 2 ·Orthopedic

EVOLUTION® Hinge Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

MACROPORENS CRANILOC

FDA 510(k)

FDA Class 2 ·Neurology

MACROPOREMX MANDIBULAR FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MACROSORBOS PROTECTIVE SHEET

FDA 510(k)

FDA Class 2 ·Orthopedic

DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

ADVANCE Porous Coated Spiked Tibial Base

FDA 510(k)

FDA Class 2 ·Orthopedic

EVOLUTION Revision CCK System

FDA 510(k)

FDA Class 2 ·Orthopedic

MACROPORE OS TRAUMA

FDA 510(k)

FDA Class 2 ·Orthopedic

PROFEMUR TL CLASSIC LONG NECK HIP STEMS

FDA 510(k)

FDA Class 2 ·Orthopedic

Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique

FDA 510(k)

FDA Class 2 ·Orthopedic

Prime and DYNASTY® Additive Manufacturing Shells

FDA 510(k)

FDA Class 2 ·Orthopedic

MACROPORE SURGIWRAP (TS)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery