ObamaCares Killer Device Tax

ObamaCare’s Killer Device Tax (WSJ) Much of the political conversation in Washington these days concerns innovation, job creation and competitiveness. But talk is cheap, and elected officials must enact policies that enhance economic activity and job creation. The medical device industry is an example of Washington doing exactly the opposite. Medical device manufacturing is one of [...]

FDA Will Consider More Rigorous Testing for Metal-on-Metal Hip Products

FDA Will Review MoM Hip Safety (MedPageToday) FDA seeks more advice on metal hip implants (FDA press release) The FDA “is considering whether to make metal-on-metal hip systems subject to more rigorous testing and premarket review requirements,” the agency said. An FDA advisory committee will meet June 27-28 to review data on failure rates, patient complications, and [...]

Spine Startup, Lucero Medical, Draws an FDA Warning Letter After Inspection

Spinal fusion device draws FDA warning letter (Josh Sandberg) Spinal device company Lucero Medical has received a warning letter from the U.S. Food and Drug Administration, primarily over documentation and quality control issues. Hinckley, Ohio-based Lucero produces a cylindrical-shaped, titanium mesh device that’s implanted in the spine to replace collapsed or diseased vertebrae. The device, called the Enduramesh, is designed [...]

Oops, Global Medical Fined $1M by FDA for Jumping the Gun on Biologics Approval

FDA’s Globus Oops (Walter Eisner @ OTW) Oops. The FDA has changed a statement made in a February 28 press release announcing a $1 million dollar penalty settlement with Globus Medical, Inc. and its CEO for marketing an unapproved medical device. The agency originally wrote: “The device-clearance process assures the quality and safety of devices before [...]

FDA Threatens Synthes With Fines and Regulatory Action Over GMP Problems

FDA threatens fines, regulatory action over Synthes’ GMP problems (Fierce Pharma Manufacturing) The international medical device company Synthes has been producing rods, power tools and screws for orthopedics for years. But now the FDA is putting the screws to Synthes. Finding complaint handling and production standards sorely inadequate at Synthes’ West Chester, PA, plant, the FDA [...]

Synthes Gets a Warning Letter From FDA for Poor Complaint Management

Synthes gets warning letter over complaint management (MedCityNews)   Swiss medical device manufacturer Synthes has received a warning letter from U.S. regulators taking issue with the company’s management of complaints over its devices and problems with orthopedic surgery devices. It said a review of its factory in West Chester, Pennsylvania between June and September 2011 revealed [...]

Orthopedic & Spine 510(k) Clearances in February = 44

44 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in February (Laura Miller @ Beckers) Pass LP Spinal from Medicrea International. Klassic Knee System from Total Joint Orthopedics. Synthes USS Connectors from Synthes Spine. Savannah Technologies Spinal System from Savannah Technologies. Conserve Thin Shell from Wright Medical Technologies. Coral Spinal System from Theken Spine. ConforMIS iTotal CR Knee Replacement System from ConforMIS. Metatarsal [...]

FDA Fines Globus Medical and CEO $1M for Selling “rejected” Bone Graft Products

FDA fines Globus Medical and CEO $1M for selling rejected bone graft products (MassDevice) Orthopedics device maker Globus Medical and its CEO agree to pay a $1 million fine after an FDA inspection finds the company marketing bone graft products that the agency had denied for the U.S. market. Orthopedics device maker Globus Medical will pay [...]

Report: Regulators in US & EU Where Slow to Inform Patients of Metal-on-Metal Issues

Report Slams Response to Metal Hip Troubles (MedPageToday) Regulators on both sides of the Atlantic were slow to inform patients and their doctors about problems with metal-on-metal hip implants and relied on industry officials and consultants in crafting their responses, the BMJ charged. According to a report appearing online in BMJ, regulators in the U.K., the U.S., and elsewhere [...]

J&J Hip Recall: Internal Emails Detail FDA’S Non-Approvable Letter

  J&J hip recall: Internal emails detail FDA’s non-approvable letter (MassDevice) Uncovered internal emails from Johnson & Johnson subsidiary DePuy Orthopaedics highlight the company’s decisions to abandon a PMA bid for the now-defunct ASR hip resurfacing implants amid “a significant number of revisions” during clinical trials. A newly uncovered Johnson & Johnson email may pose problems [...]

Audio Interview: Spine Startup – Soteira CEO Larry Jasinski

Click to play MassDevice Podcast: Soteira CEO Larry Jasinski (MassDevice) Soteira CEO Larry Jasinski talks to MassDevice about overcoming the odds with spinal fusion devices and managing a 510(k) win even after the FDA switched things up mid-stream. Soteira CEO Larry Jasinski is no stranger to adversity. In the last 5 years the spinal fusion device maker has [...]

Israeli Company Wins 510(k) Clearance for TLIF Fusion Device

Award Winning Israeli Spine Company Gets 510(k) Clearance (Bilione Young @ OTW) NLT SPINE, an Israeli developer of minimally invasive spine surgery (MISS) products, has just received FDA 510(k) clearance for its PROW FUSION device. NLT SPINE is a winner of the 2011 Spine Technologies Award, given byOrthopedics This Week during the North American Spine Society conference [...]

Wright Medical Get FDA Clearance for Patient-Specific Total Ankle Replacement

  Wright Medical Group, Inc. Announces 510(k) Clearance and Limited U.S. Launch of the PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides (press release) Wright Medical Group, Inc. a global orthopaedic medical device company, today announced the 510(k) clearance and limited launch of the PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides for total ankle replacement. Designed for use with the Company’s [...]

Eden Spine Receives FDA Clearance for New Corpectomy Device

  Eden Spine’s Giza Receives Clearance (Walter Eisner @ OTW) Eden Spine LLC has received FDA 510(k) clearance for its new corpectomy device called the Giza. The company announcement on February 2, states the device is an expandable titanium VBR (vertebral body replacement), with rotatable endplates that provide multiple angulation options by simple endplates rotation. According [...]

The US Medical Device Industry Agrees to Pay the FDA $595M in New Fees

  US medical device industry and FDA agree on fees (press release) * Industry to pay $595M in next 5 years * Missed earlier deadline for fee agreement * FDA to hold more meetings with devicemakers WASHINGTON, Jan 31 (Reuters) – U.S. medical device makers agreed to double the fees they pay the Food and Drug [...]

FDA Issues Guidance on IDEs for Knee Cartilage Repair/replacement

          FDA issues guidance on IDEs for knee cartilage repair/replacement devices and drugs (MassDevice) The FDA issues new guidance on proper submissions for investigational device exemption and investigational new drug applications for products intended to repair or replace knee cartilage. The FDA this week issued new guidance on getting clearance for clinical trials of [...]

J&J’S Depuy to Stop Selling All Custom Devices After Receiving FDA Warning Letter

      J&J’s Depuy to stop selling all custom devices in response to FDA warning (MassDevice) Johnson & Johnson subsidiary Depuy Orthopaedics decides to stop selling all custom devices following an FDA letter warning the company to file new PMA and 510(k) applications for several components. Johnson & Johnson subsidiary DePuy Orthopaedics decided to stop [...]

Get Ready for the Chinese Total Joint Manufacturers! FDA Approves New Chinese Hip and Knee Implants

    China Kanghui Receives FDA 510(k) Approval for Hip & Knee Systems (press release) Website China Kanghui Holdings (“Kanghui” or the “Company”), a leading domestic developer, manufacturer and marketer of orthopedic implants in China, today announced that the Company’s wholly-owned subsidiary, TGM Medical, Inc. (“TGM”), has received approvals from the FDA for its Helicon Hip System [...]

Spine 510(k) Clearances in December = 26

     26 Spine Devices Receive FDA 510(k) Clearance in December (Laura Miller @ Beckers) Acculif TL-PEEK IBF Cage from Coalign Innovations. Renaissance System from Mazor Robotics. Axle PEEK Interspinous Fusion System from X-Spine Systems. Athena Pedicle Screw System from Royal Oak Medical Devices. Shield Kyphoplasty System from Soteira. VariLIFT Cervical Interbody Fusion System from Wenzel Spine. Zavation Cervical Plate System from Zavation. [...]

New Bill Would Require Companies to Monitoring of 510(k) Implants Systems

     Bill Would Require More Monitoring of Implants (NY Times) Amid growing problems with artificial hips and other medical implants, bipartisan legislation was introduced in the Senate on Wednesday that would force manufacturers to track the performance of such products after they were approved for sale. The bill would allow the Food and Drug Administration [...]

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May 18, 2012

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