List of 30 Recently Launched Orthopedic Products With Descriptions

30 Orthopedic and Spine Devices to Know (Reprinted from Becker’s Orthopedic and Spine Review) Here are 30 orthopedic and spine devices to know. Many of them were recently launched or approved by the FDA. The devices are listed in alphabetical order. This list is not an endorsement of these devices. AperFix II from Cayenne Medical. [...]

Spine Innovation at Pioneer Surgical in Marquette MI

Marquette company innovating in orthopedics and biologics (ConnectMidMichigan.com)

Medtronic Trims 2011 Earning Outlook and Plans to Cut 2,000 Jobs

Medtronic trims 2011 view, to cut up to 2,000 jobs (Reuters) Medtronic Inc cut its full-year earnings forecast, hampered by weakness in key medical device markets, and said it would eliminate up to 2,000 jobs. Medtronic said it would take a one-time charge in the fourth quarter for the job cuts that could total up to [...]

VC Speaks Out: Fix FDA or Watch Business Go Overseas

Top device VC: Fix FDA or watch business go to Costa Rica (MassDevice) The “inefficient and unpredictable regulatory system” at the Food & Drug Administration is “putting thousands of local jobs and billions of dollars in economic activity at risk — and may cause America to give up its mantle as the world’s leading medical [...]

The FDA Backlash Reaches a U.S. House Subcommittee

Medical device industry tees off (MassDevice) The medical device industry’s public relations campaign to push the regulatory agenda its way hit another level today, with industry advocates testifying before a U.S. House subcommittee, studies taking aim at the Food & Drug Administration and even an op-ed from a pair of friendly legislators.

KYOCERA and Japan Medical Materials Corporation Open U.S. Design Center for Medical Components

KYOCERA and Japan Medical Materials Corporation Open U.S. Design Center for Medical Components (EON) Kyocera Industrial Ceramics, a medical implant manufacturing company, has opened its new orthopedic design center in Somerset, N.J., according to an AZ Materials report. The new center is a collaboration between Kyocera Industrial Ceramics and Japan Medical Materials, a Kyocera Group company. [...]

MedMarket Diligence Releases Report on Sealants, Glues, Hemostasis in Orthopedic Applications

Potential for Sealants, Glues, Hemostats and Other Securement Products in Orthopedic Applications (MedMarket Diligence) Frequency of Major Surgical Interventions (000)

Editorial: Stryker’S Presence Is a Boon for Kalamazoo Area

Editorial: Stryker’s presence is a boon for Kalamazoo area (MLive)

AAOS Summarizes the Negative Metal-on-Metal Clinical Data Presented at AAOS

AAOS: Little Love for MoM in Studies (MedPageToday) AAOS… ”Metal-on-Metal implants are associated with higher revision rates and failure rates and may promote pseudotumor formation”

46 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in January

46 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in January (Beckers) 1. Congruent Bone Plate System from Acumed. 2. Multifit Total Hip System from Otis Biotech. 3. Hip Arthroscopy Repair Instrument Tray from Smith & Nephew. 4. Tibial Graftbolt from Arthrex. 5. Synthes 6.0 COCR and CPT TI-3 Rods from Synthes Spine. 6. Caliber [...]

AAOS: No Benefit in Mobile-Bearing Knee Implants

AAOS: No Benefit in Mobile-Bearing Knee Implants (MedPageToday) Mobile-bearing knee replacements appear to offer no advantages in range-of-motion, pain relief, or other outcomes over traditional fixed-bearing designs, researchers reported. Two randomized multicenter trials, including more than 500 patients, presented at the American Academy of Orthopaedic Surgeons’ annual meeting here, failed to confirm any of the [...]

AAOS: Knee Replacements Hold Up Well After 20 Years

Knee replacements hold up well after 20 years (LA Times) Knee replacement surgery has become common in the last 30 years, and more younger people with bad knees are considering the surgery. A study presented Wednesday at the American Academy of Orthopaedic Surgeons annual meeting may reassure them that the replacement should hold up for [...]

AAOS: Metal-on-Metal Hips, Dr. Josh Jacobs Says We Need More Look for Better Bearings

AAOS Second VP: More Innovation Needed to Develop Lasting Hip Implant (ODT Mag) VIDEO: Maybe it was some sort of sixth sense or perhaps it was just coincidence, but Joshua J. Jacobs, M.D., has never been a big fan of metal-on-metal implants.

New iPhone App to Track Surgery Schedules, Physician Preferences, Inventory Movement and Implant Usage

WebOps™ Releases iPhone Application for Flagship Product, WebOps Logistics™

Medical Outlook in 2011

Medical Outlook 2011 (Today’s Medical Developments) Medical devices continue to offer strong showings and high growth, but growth in the life sciences industries will greatly depend on how the FDA responds to growing complaints that they are stifling medical technologies.

Sanofi to Acquire Genzyme for 4.7X Sales Multiple

Sanofi-Aventis to Acquire Genzyme (LAUREN UZDIENSKI @ HealthPointCapital) After a long and very public negotiation, Genzyme has agreed to be acquired by Sanofi-Aventis for $74 per share, with the total deal valued at around $20.1 billion. The transaction represents a 48% increase over the close on July 2, before rumors began to circulate that Genzyme was an [...]

Stryker Challenges Competitive Metal-on-Metal Hips With Its New Ceramic Hip Clearance

Stryker’s Newest Clearance Hits MoM Competitors (OTW)

FDA Warns Patients of Issues With Metal-on-Metal Hips

FDA Airs Concerns About Hip Joints to Patients (MedPageToday) In a set of web pages, the FDA cited problems that can arise from the inevitable release of metal particles as patients flex their new joints. Adverse reactions in the bones in which the implant is embedded also occur in some patients. “Metal-on-metal hip replacement systems have [...]

DJO Continues to Transform Itself After the 2007 Merger

MEDICAL: Vista’s DJO reports progress in merger (North County Times) DJO Global and Lima Corporate Expand U.S. Partnership (press release) DJO Inc. has wrapped up three years of transformation with a new name, DJO Global Inc., and an expanded mission to be a global vendor of orthopedic medical devices. The company was bought for $1.3 [...]

10 Spine Surgeon Leaders at Academic Institutions That You Need to Know

10 Spine Surgeon Leaders of Academic Medical Centers to Know (Beckers)

Trauma Extremities Startup, Sonoma Orthopedic Products, Lands $22M in Series D Funding

Sonoma Orthopedic Products raises $22 million (press release)

Report: Patient Safety Is Not Compromised With Faster EU Regulatory Process

AdvaMed-Sponsored Report Says Safety Not Improved By Longer Approval Process (WSJ) A new report prepared by the Boston Consulting Group shows that a slower regulatory process in the U.S. doesn’t improve the safety of patients here compared to Europe. Findings show that the number of products pulled due to “significant health risks” is about the same in [...]

The “only” Orthopedic PMA Approval in 2010 – Depuy Gets Ceramic Hip Clearance

Ceramax: FDA’s Lone 2010 Ortho Approval DePuy Orthopaedics’ Ceramax Ceramic Total Hip System has been approved, with conditions, by the FDA. This gives DePuy the distinction of being the only orthopedic device company to receive an approval from the FDA for a PMA (premarket approval application) in all of 2010. The FDA approved a total [...]

3D X-Rays for Lower Limb Approved by FDA

FDA Clearance for EOS imaging (OTW)

7 Critical Orthopedic and Spine Device Industry Trends From Millennium Research Group

7 Critical Orthopedic and Spine Device Industry Trends (Beckers) Expert analysts from Millennium Research Group discuss the current trends in total joint replacement and spine surgery devices. Minimally invasive procedures Shoulder implants Hip implants and resurfacing products Smaller implants for knee surgery Lateral interbody fusion devices Bone morphogenic proteins Non-fusion spine procedures Learn more about Millennium [...]

AAOS Responds to FDA’S Public Health Communication on Metal-on-Metal Hips

AAOS Responds to FDA’s Public Health Communication on Metal-on-Metal Hips (press release) Orthopaedic surgeons raise awareness and provide information on hip replacement components to patients, colleagues and medical community at-large

CEO Change at Smith & Nephew – Dave Illingworth Out, Olivier Bohuon In

S&N announces chief executive to retire (FT) Mr Illingworth will be succeeded by Olivier Bohuon on April 1 at Smith & Nephew’s annual general meeting. Mr Bohuon most recently was chief executive of Pierre-Fabre, the French pharmaceuticals group, but left his position a few weeks ago after just five months in the job. Previous to [...]

The FDA Is Forcing Medical Device Companies to Focus on OUS Markets

Medical Device Makers Shun United States (NYTimes) Medical device industry executives and investors are complaining vociferously these days that the industry’s competitive edge in the US and overseas is being jeopardized by a heightened regulatory scrutiny. In 2010, the F.D.A. granted 19 premarket approvals, down from 48 in 2000.

CEO Change at Cayenne Medical – David Springer to Replace Jim Hart

Cayenne Medical, Inc. Appoints David B. Springer President & CEO (press release)

FDA to Approve Innovative Medical Devices in Half the Time

FDA to Approve Innovative Medical Devices in Half the Time (MedScape) FDA Launches Medical Device Innovation Initiative (FDA) FDA Introduces Medical Device Innovation Initiative (HealthPointCapital) The FDA proposes the Innovation Pathway, a priority review program for new, breakthrough medical devices and announced that the first submission will be a brain-controlled, upper-extremity prosthetic that will serve [...]

Departure of DJO’S CEO Leaves the Company With Uncertain Future

Medical Device Maker DJO Seeking New CEO (San Diego Business Journal) DJO Incorporated Announces Planned Transition of President and CEO Les Cross (press release) The departure of DJO Inc.’s CEO raises the question of what the future holds for the Vista-based medical device manufacturer.

ConforMIS Gains FDA Clearance for 1st Patient Specific Knee Instrument System

FDA Clears First Patient-Specific Implant System for Total Knee Replacement (press release) The iTotal CR system uses computer modeling to build a 3D image of a patient’s knee from CT scans. That image then guides the proprietary design and manufacture both the jigs and the personalized implants that resurface the patients’ articular surfaces.

CEO Survey Says That California’S Biomedical Industry Is Poised for Growth

California’s Biomedical Industry is Poised for Growth Despite Increasing Global Competition, According to the 2011 California Biomedical Industry Report (press release)

Synthes Voluntarily Removes N-Hance Spine Fusion System From the US Market

Synthes Packs Up N-Hance in U.S. (OTW) Synthes Spine is not waiting for a warning letter from the FDA regarding the company’s requirement to submit an overdue postmarket surveillance study plan for the N-Hance Fusion System. Instead the company has decided to voluntarily withdraw the device from the U.S. market. This adds another layer to [...]

Use of PRP Reduces Blood Loss After Total Knee Surgery

PRP Cuts Surgical Blood Loss (OTW) Patients undergoing total knee replacement surgery experience markedly less blood loss when treated with platelet-rich plasma (PRP), according to Dr. Jeffrey Traina, an orthopaedic surgeon at Natchez Community Hospital. PRP use is a relatively new therapy, Traina said, so scientific data is just being gathered: “My study looked at [...]

Experts See 6 Challenges for Medical Device Industry Post-Reform

Orthopedic and Spine Device Industry Post-Reform: 6 Challenges (Beckers) Consolidation within the medical device industry. Changes in the FDA 510(k) clearance process. Reimbursement for orthopedic and spine procedures. Lowering the cost of healthcare. Connecting with orthopedic surgeons. Device marketing and communication with customers.

Tornier IPO Price Is Set at Bottom of Range by Underwriter

UPDATE 1-Tornier IPO prices at bottom of range-underwriter (Reuters) Tornier B.V. files for upto $205 mln IPO (Reuters) S-1 Filing (SEC) Tornier BV unveiled estimated terms for its planned initial public offering. The company is selling 8.75 million ordinary shares with an estimated price of between $19 and $21 per share. In 2006, the company was [...]

The 4 Biggest Opportunities in Spine Surgery From the surgeon’S Perspective

Biggest Opportunities in Spine Surgery — From Spine Surgeon Dr. Jay Khanna of Johns Hopkins (Becker) Minimally invasive spine surgery Cost containment in spine surgery Increased use of biologics in spine surgery Image guidance safety and radiation dose reduction

Vertiflex Lands $14M in Funding for Superion Clinical Trial

VertiFlex®, Inc. Announces Financing and New Investment Partner (press release) VertiFlex, a leading innovator of percutaneous and motion preserving spinal surgery technologies, today announced completion of a $14M equity placement, with provision for an additional $14M investment within twelve months. The new capital will be used to complete enrollment in the Superion® Interspinous Spacer (ISS) [...]

Zimmer Makes Job Cuts at Its Home Base

Zimmer makes job cuts at Warsaw operation (Fort Wayne Jounal Gazette)

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February 22, 2012

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