Orthopaedics

BioMedical Enterprises (BME), Inc. has announced the FDA clearance of an upgrade to the patent-pending HammerLock® Nitinol Intramedullary Fixation System.

Verasense™knee technology developer, OrthoSensor™, has partnered with Valtronic for the contract manufacture of the devices to satisfy its growing customer list. A first unit has been shipped under the agreement.

Back in July, Dallen Medical submitted its 510(k) for the Tensyn™ band for fixation of ankle syndesmosis. Now the company is reporting that the FDA has duly cleared the product for market.

Last week we shared some pretty fiery correspondence that was made public by ConMed shareholder Voce Capital. Ten days later we see a response from ConMed, which has been filed with the SEC as part of the company’s fiduciary duty.

Titan Spine has dedicated itself to understanding surface texture and its impact on implantable orthopaedic materials. The company’s lofty ambitions to see its technology driving a paradigm shift have been boosted by recent revenue figures showing rapid growth, coupled with a distribution deal with Ortho giant Biomet in Germany.

It seems OrthoSensor has the technological capability to make knee prosthesis manufacturers’ implants look really good. Now Zimmer has signed up with the company to co-market the Verasense system alongside its own knee systems.

It’s been thought for over a decade that use of the anteromedial(AM) portal in ACL reconstruction is the best way of achieving an anatomical femoral socket, compared with drilling it through the tibial tunnel. Mitek sports medicine is showcasing its new purpose-designed Rigidfix® arc which facilitates Rigidfix cross pin fixation using the AM approach.

Shareholder are not always happy campers, but a new press release issued by one of ConMed’s institutional investors has been written in such a coruscatingly damning tone that we thought it worthy of presentation to our audience of cultured types who appreciate a bit of literary creativity. Not sure ConMed will be quite so appreciative.

A changing sales mix, the impact of the US sales tax and ongoing increased provision for potential settlement of outstanding alleged stock fraud all contributed to ArthroCare’s lower than predicted earnings. This, despite healthy top line sales growth in Q3.

Johnson & Johnson is considering a settlement with injured hip implant patients that could total more than $3 billion. Sources close to the matter have told Bloomberg that the company is weighing their options in settling thousands of cases involving DePuy hip implants that have been linked to early failure rates and a host of serious complications.

Musculoskeletal device specialist DJO Global, Inc., tells us its Match Point System™ patient-specific shoulder instrumentation has seen its first use in Reverse® Shoulder System cases in Australia Florida.

Wright Medical Group, Inc. is to acquire French ortho extremity company Biotech International for $80 million. It says this will significantly expand Wright’s direct sales channel in France and international distribution network and add Biotech’s complementary extremity product portfolio.

Silicon Nitride has strong claims to be the perfect implant material. Its characteristics make it suitable for spinal fusion devices, and K2M will now commence distribution of Amedica’s unique device offering in Europe.

Orthopaedic device giant Biomet, Inc., has trumpeted the first U.S. implantation of its Comprehensive® Nano Stemless Shoulder. The procedure was part of an FDA Investigational Device Exemption (IDE) multi-center prospective clinical study.

Surgical implant company RTI Surgical Inc. has announced preliminary revenue results for the third quarter that are way off prior guidance. In the same release it confirms a new agreement with Medtronic Sofamor Danek USA, Inc. to process allograft implants for use in spinal surgeries.

It’s a bit of a “so-what” story really, but when the FDA sends you a warning that you haven’t acted on its observations it is kinda newsworthy. Globus says it’s on top of the situation.