Product Summary

In the past thirty years since its inception, Implantology has been actively engaged in the development of orthopedic hip and knee joint prostheses and related surgical instrumentation. The Company's hip and knee prosthesis designs incorporate unique and clinically significant features, which have resulted in the development of a rather comprehensive product line of Orthopedic implant devices.

The Company's strategic and intellectual accomplishments include proprietary FDA 510(k) premarket approvals, which are as follows:

Four (4) hip stem prostheses,
Two (2) systems of primary and revision acetabular component rostheses,
One (1) system of Bipolar femoral head prostheses,
Two (2) total knee prostheses,

Product Design Features

Total Hip and total Knee prosthesis components which utilize materials of clinically proven in-situ compatibility.
Hip and Knee prosthesis systems which provide improved surgical versatility and biomechanical function.
Hip and Knee prostheses systems which permits the surgeon to address a wide-range of surgical indications from primary routine articular involvement to complex revision cases with gross bone loss and/or severe joint instability.
Novel prosthetic component designs allow improved intramedullary fit, associated fixation performance and joint biomechanics by suitably integrating sexually-related (Male/Female), congenitally-related (CDH/JRA) and ethnically-related (Eastern/Western) anatomical skeletal characteristics.

The femoral Hip system components incorporate a proprietary medullary stem design methodology which improves the probability of achieving both a (reproducible) precise and stable intramedullary stem fit in a wide variety of physiologically sized femurs and concurrently, proper biomechanics of hip joint head center position.

The Knee prosthesis system will reflect many design and clinical advantages, which includes Condylar and tibial resurfacing and Posterior stabilization of the knee joint over the full range of flexion. The design offers a unique hinge-type of knee prosthesis which provides multi-pivot motion, like the natural knee, and other technical advantages, including a mechanically linked design with a unique natural-like femoro-tibial knee joint motion including posterior roll-back. Additionally, the Knee prosthesis components incorporate a common design theme relative to articular shape, bone resection requirements and component sizing.

Coatings

The Implantology 510(k) approvals cover several key technologies/concepts. One of these technologies includes coatings. These are referred to in the Implantology claims as partially porous coatings (K915385), fully porous coatings (K9154391, K915529, K915527), and hydroxylapatite coatings (K934729).

Implantology Bipolar Femoral Head components (K915528) utilize cobalt and chromium with a locking ring. Current technology also includes molybdenum and sometimes polyethylene, the latter of which is considered extremely durable.

The Implantology Condylar Resurfacing Total Knee (K915584) and Posterior Stabilized Total Knee (K915798) are also composed of cobalt and chromium. Some knee device components also include polyethylene. Although polyethylene works well in femoral head components, failures have been found in polyethylene tibia posts. This is highly unlikely to occur in the Implantology device.

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