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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Our results of operations could be substantially affected not only by global economic conditions, but also by local operating and economic conditions, which can vary substantially by market. If, as a result of these investigations described above or any additional investigations, we are found to have violated one or more applicable laws, our business, financial condition, results of operations and cash flows could be materially adversely affected.

This combination of the best in 3i innovation is intended to help clinicians address their clinical challenges and deliver upon patient expectations for sustainable aesthetic outcomes. This material is intended for health care professionals. Our team is led by Jeffrey R.

This material is intended for health care professionals. We only operate as a Business Associate to Covered Entities in a limited number of instances.

viomet We make estimates regarding the future use of these products and provide a provision for excess and obsolete inventory. Spinal fusions are surgical procedures undertaken to establish bony union between adjacent vertebrae. This market is comprised of five product categories: We may be subject to intellectual property litigation and infringement claims, which could cause us to incur significant expenses or prevent us from selling our products.

Through a series of dilating cannulae and various instruments, the systems allow the surgeon to access the anatomy through a percutaneous approach and safely bilmet commercially available bone cement under low, controlled pressure.

Efficacy of implanted bone growth stimulation in instrumented lumbosacral spinal fusion. Financial Statements and Supplementary Data. Find A Sales Associate.

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We intend to continue to pursue growth opportunities in sales internationally, which could expose us to additional risks associated with international sales and operations. We offer a variety of spacer products for the thoracolumbar and cervical market segments.

If we fail to retain our existing relationships with our independent sales agents and distributors or establish relationships with different agents and distributors, our results of operations may be negatively impacted.

Our business may be harmed as a result of product liability litigation. As planning and guide fabrication are based upon computed tomography scans, this may result in more accurate implant placement when combined with the depth and rotational control offered by our instrumentation.

The bimoet under our senior secured credit facilities will have the discretion to release the guarantees under our senior secured credit facilities in a variety of circumstances. As of May 31, We believe we have a number of competitive strengths that will enable us to further enhance our position in the orthopedic medical device market.

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In addition, our obligations to protect patient and customer information have increased significantly.

We believe that all of our facilities are adequate, well maintained and suitable for the development, manufacture, distribution and marketing of all our products.

This exciting program offers turnkey marketing tools that clinicians can use to educate their patients inrux the benefits of immediate full arch restoration. As biomett placement position can be replicated as planned, this may also provide the opportunity for fabrication of a provisional prosthesis in advance of surgery, thereby allowing for a complete implant restoration in one patient visit.

We believe this service continues to enhance our reconstructive sales by strengthening our business relationships with orthopedic surgeons and augmenting our reputation as a responsive company committed to excellent product design. Our implants are designed to facilitate efficient, versatile, and reproducible spinal fusion procedures ready to meet the needs of surgeons and their patients in an ever-changing global spine market.

We have 14 manufacturing operations located throughout the world. Unfavorable conditions can depress sales in a given market and may result in actions that adversely affect our margins, constrain our operating flexibility or result in charges which are unusual or non-recurring.

If we are declared bankrupt or insolvent, or if we default under our senior secured credit facilities, the lenders could declare all of the funds borrowed thereunder, together with biomt interest, immediately due and payable. We could be subject to further governmental investigations or actions by other third parties as a result of our settlement with the Inux and the Office of the Inspector General of the U.

We are unable to predict the 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.

In many countries, hospitals and clinics are government-owned and healthcare professionals employed by such hospitals and clinics, with whom we regularly interact, may meet the definition of a foreign official for purposes of the FCPA. We now offer a complete product line of low-profile, locked periarticular plates and bikmet mini and small fragment sets, which utilize platform technologies. We believe we continue to be the market leader for products accommodating minimally-invasive knee techniques.

We distribute both non-invasive and implantable electrical stimulation devices that surgeons can use as options to provide an appropriate adjunct to surgical intervention in the treatment of spinal fusion applications.

The implementation of these requirements could affect the sourcing and availability of minerals used in certain of our products. Our properties are subject to various federal, state, foreign and local laws and regulations regulating their operation. Pursuant to the DPA, the DOJ has agreed not to prosecute Biomet in connection with this matter, provided that Biomet satisfies its obligations under the agreement over the next three years.

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The following discussion reflects the results of operations and financial condition of Biomet, Inc. In addition, they may be rehydrated with blood, bone marrow aspirate BMA or saline solution, and they expand to fill the contours of any void, thereby minimizing the space between the graft and the host bone.

We can make bimet assurances as to the time or resources that will be needed to devote to this litigation or its final outcome. Although the terms of our senior secured credit facilities and the indentures contain restrictions on the incurrence of additional indebtedness, these restrictions are subject to a number of important exceptions, and indebtedness incurred in compliance with these restrictions could be substantial.

Spine Products | Zimmer Biomet

In general, these statutes and regulations require that manufacturers adhere to certain standards designed to ensure the safety and efficacy of medical devices and related lndux products. We have three geographic markets: The design biomeet for increased osteoinductivity, when compared to demineralized cancellous bone, and its unique cross-hatched texture creates a indus that provides both strength and flexibility.

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. Compliance with the terms of the DPA requires cooperation ineux many employees and others and may divert biomte financial and human resources from our other business activities.

We believe our future success will depend upon, among other things, our service and responsiveness to our distributors and orthopedic specialists, the continued strong clinical results of our products, and upon our ability to design and market innovative and technologically-advanced products that meet the needs of the marketplace. Our substantial indebtedness, combined with our other financial obligations and contractual commitments, could have important consequences.

We believe that our cash, other liquid assets and operating cash flow, together with available borrowings and potential access to credit and capital markets, will be sufficient to meet our operating expenses, research and development costs and capital expenditures and service our debt requirements as they become due.

Spine Products

Risks Related to Our Business. In addition, the terms of existing or future debt agreements may restrict us from pursuing any of these alternatives.

The process, which is managed by each of our global Product organizations, breaks each project down into six stages of work and further divides these stages by formal review gates.

Our backlog of firm orders is not considered boimet to understanding our business.