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Both systems are indicated for treatment of osteoarthritis, rheumatoid arthritis, avascular necrosis, and traumatic arthritis. Contraindications include: excessive bone loss, septic arthritis, periarticular osteomyelitis, and local or systemic infection.

proprietary name: Horizon Hip System common name: prosthetic. Total Hip System classification name: prosthetic, Total Hip System

Femoral component: The Horizon Femoral Stem is manufactured from cobalt chrome and features a collar to distribute stress in a physiological manner. It is available with or without porous coating. The femoral component is available in five sizes: 12mm, 15mm, 16,5mm, and 18mm.

Acetabular Insert: The Horizon Acetabular Insert is manufactured of UHMWPE. It is designed to snap fit into the acetabular shell. The insert will accept 28mm heads. It is offered in sizes ranging from 46mm to 60mm.

Acetabular Shell (cup): The Horizon Acetabular Shell is manufactured of cobalt chrome. It features three spikes to prevent rotation. It also features a groove on its I.D. to accept the mating acetabular insert. The acetabular shell is porous coated to promote long term fixation. The acetabular shell is available in eight sizes: 46mm, 48mm, 52mm, 52mm, 56mm, 56mm, and 60mm.

This document is a 510(k) summary for a medical device (Horizon Hip System) and does not describe a study involving an algorithm or AI. Therefore, it does not contain the information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, or comparative effectiveness studies for an AI-powered device.

The provided text focuses on demonstrating substantial equivalence between the Horizon Hip System and predicate devices (Depuy AML femoral stems and AML Plus Depuy cup) based on material, design, and intended use for regulatory clearance, not on reporting performance metrics from a technical study.

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