BIOMET INDUX PDF

The Indux™ Cortical Strip is a robust single piece construct with a unique cross- hatch pattern that Biomet Spine & Bone Healing Technologies launches. of Biomet, Inc. or one of its subsidiaries unless otherwise indicated. Rx Only. Indux™ Cancellous Sponge and Indux™ Cancellous Strip. The Indux™ Cancellous. Biomet Spine introduced Cellentra VCBM (Viable Cell Bone Matrix), the Stimulation products which includes the Indux™ Cortical Strip and.

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The discoloration was caused by the affected implants coming into contact with residual machining fluid that may have been left on the metal packaging insert for the products. The unique spacer band assists with accurate radiographic visualization and the sophisticated instrumentation simplifies implantation. We are subject to increasing pricing pressures worldwide as a result of growing regulatory pressures, as well as the expanding predominance of managed care groups and institutional and governmental purchasers.

While we are unable to predict the extent to which our business may be affected by future regulatory developments, we believe that our substantial experience in dealing with governmental regulatory requirements and restrictions throughout the world, our emphasis on efficient means of distribution and our ongoing development of new and technologically-advanced products should enable us to continue to compete effectively within this increasingly regulated environment.

We are currently restricted in our ability to pay dividends under various covenants of our debt agreements, including our credit facilities and the indentures governing the notes issued by Biomet, Inc.

Spine Products | Zimmer Biomet

Current assets less current liabilities. New risk factors affecting us emerge from time to time and it is not possible for management to predict all such risk factors. In addition, we are required to implement and maintain stringent reporting, labeling and record keeping procedures. Our backlog of firm orders is not considered material to understanding our business. We can make no assurance as to the final outcome of this matter.

Office and research and development facilities for Trauma operations. We have a highly experienced management team at both the corporate and operational level. The ultimate financial impact with respect to this matter will depend on many factors that are difficult to predict with the limited information received to date and may vary materially based on the number of and actual costs of patients seeking testing inrux treatment services and the number of and actual costs to settle any lawsuits filed against us, and could have a material adverse effect on our financial conditions, results of operations and cash flow.

Our European manufacturing locations in South Wales, England, France, Spain, Switzerland and Germany also provide good sources for skilled manufacturing labor. Major competitors in our five product categories are set forth below by market category. Building on the success of the T. In addition, any failure to make payments of interest and principal on our outstanding indebtedness on a timely basis would likely result in a reduction of our credit imdux, which could limit our ability to incur additional indebtedness.

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Our revenues and profitability depend largely on the ability of independent sales agents and distributors to sell our products to customers. We may be unaware of intellectual property rights of others that may cover some of our technology. We are unable to predict invux likely duration and severity of the current disruption in financial markets and adverse economic conditions, or the effects these disruptions and conditions could have on us.

The key to a labral repair is to remove the least amount of bone possible, and the smaller anchor diameter allows multiple anchors to be placed without removing large amounts of bone. Claims of noteholders will be structurally subordinated to claims of creditors of all our non-U. We believe our headquarters, manufacturing and other facilities are suitable for their respective uses and are, in all material respects, adequate for our present kndux.

We conduct a significant amount of our sales activity outside of the United States, which jndux us to additional business risks and may adversely affect our results due to increased costs. While the indentures limit the ability of our subsidiaries to incur consensual restrictions on their ability to pay dividends or make other intercompany payments to us, these limitations are subject to certain qualifications and exceptions.

If we breach our covenants under our senior secured credit facilities and seek a waiver, we may not be able to obtain a waiver from the required lenders.

If rating agencies assign a lower than expected rating or reduce, or indicate that they may reduce, their ratings of our debt in the future, the trading price of the notes could significantly decline. These third-party payors may deny reimbursement if they determine that a device used in a procedure was not in accordance with cost-effective treatment methods, as determined by the third-party payor, or was used for an unapproved indication.

Bimoet technology permits the surgeon to utilize biome shorter plate, which helps optimize plate placement to potentially prevent impingement of the adjacent healthy disc.

All amounts are presented after giving effect to intercompany eliminations. Through a series of dilating cannulae and various instruments, the systems allow the surgeon to access the anatomy through a percutaneous approach and safely deliver commercially available bone cement under low, controlled pressure.

Spine Products

The second phase provides for a period of time in which we are allowed the opportunity to implement the monitor’s various recommendations based upon the monitor’s assessment of the effectiveness of the program. Our support of medical education programs provides important training opportunities for orthopedic surgeons early in their careers. We believe the ongoing costs and impacts of assuring compliance with the HIPAA privacy and security rules are not material to our business.

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Our future business strategy may involve the operation of other manufacturing facilities in China. A total knee replacement typically includes a femoral component, a patellar component, a tibial component and an articulating surface. In the United States, our products are marketed by a combination of independent third-party distributors, independent commissioned sales agents and direct sales representatives, primarily based on the specific product group being represented and the market characteristics of specific geographies.

Various federal and state agencies have become increasingly vigilant in recent years in their investigation of various business practices. Our involvement in the manufacture and sale of medical devices creates exposure to risks of product liability claims, particularly in the United States.

We believe that patents and other intellectual property will continue to be of importance in the musculoskeletal industry. The advantages of traditional allografts include elimination of the need for a second procedure to harvest graft material and, thus, minimization of operating time; minimization of pain, complications, and morbidity; lower supply restrictions than autograft; and availability in various shapes and forms to suit specific anatomical indications. Spine Phila Pa Bribery Act became effective, which prohibits active and passive bribery, including commercial bribery, and bribery of a foreign public official for a business purpose.

Osteoinductive Bone Fully demineralized to optimize inherent growth factors that are essential for new bone formation. Because product usage tends to follow a bell curve, larger and smaller sizes of. Safety stock levels of critical materials are reviewed on a quarterly basis to ensure these stocks are appropriately set.

Zimmer, , Biomet Indux Block Cube 14mm x 14mm – eSutures

With a few exceptions, none of our raw material requirements are limited to any material extent by critical supply or single origins. Cardiothoracic surgeons use our implants to close the sternum after a midline sternotomy or a mini-sternotomy. We also manufacture and distribute numerous other products, including craniomaxillofacial fixation devices, cardiothoracic fixation devices, autologous therapy products and services, operating room supplies, casting materials, general surgical instruments, wound care products and other surgical products.

The CID requests that we provide documents and testimony. An important component of our strategy has been the formation biome strategic alliances to enhance the development of new musculoskeletal products. Our osteobiologic products compete with other osteobiologics primarily on the basis of breadth of product line, product recognition and price.