Orthopaedics

This week sees the annual running of the Arthroscopy Association of North America (AANA) meeting. The event, which takes place from April 25-27, takes place in San Antonio, Texas and comprises its usual healthy treatment of all things arthroscopy.

Shape memory orthopedic device company MedShape, Inc. has gained US FDA 510(k) clearance for its Eclipse™ Soft Tissue Anchor. The company says its polymer anchor, is designed to attach a tendon, ligament or soft tissue to bone better than screws and other rotational devices.

Two main court cases attracted our interest this week. While the situations contrast, the common thread of patient suffering runs through both cases.

Consumer protection activist organisation, Consumers Union has urged the U.S. FDA today to adopt a proposed rule requiring metal hip implants to be reviewed through the agency’s premarket approval (PMA) process to prove that the devices are safe and effective.

Now we weren’t expecting that. With DePuy ASR trials there was a thought that it would be a matter of how much rather than whether there was an award or not. Seemingly not true as an Illinois jury finds in favour of the company and offers no settlement.

Drug delivery device company Carticept Medical, Inc., has received FDA 510(k) clearance to market its enhanced Navigator® Delivery System (DS). Navigator DS is the first and only FDA-cleared, computer-controlled injection system intended to increase the efficiency, comfort, safety and accuracy of musculoskeletal injections.

It’s all very well getting aerated about medical device failures, but it’s equally very easy to throw out the baby with the bathwater. We consider whether draconian regs would do what they’re intended to do, and whether they’d stifle innovation in the interest of…well, nobody.

Stryker’s Shapematch cutting guide was the subject of a company recall last November. Now the FDA has upgraded the recall to Class I status, indicating the high risk it has placed on use of the device.

The FDA has approved an IDE for InVivo’s biopolymer scaffold, making it the first such treatment to dip its toe in the America patient population. The new study is expected to deliver a Humanitarian Device Exemption, giving it access to market sooner than a PMA.

Biomet and OrthoSensor will co-promote Biomet’s Vanguard® Complete Knee System and OrthoSensor’s VERASENSE™ in a new deal, of which details have not been disclosed. Coupling the two technologies is expected to result in improved surgical and financial outcomes.

US shoulder device company Shoulder Options Inc., is launching its AFT™ Proximal Humerus Fracture Plate. The new plate is intended for the treatment of fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

Tenex Health’s TX1 is a clever ultrasonic device can cut and debride damaged tendon without affecting the surrounding healthy tissue. Now FDA has expanded its indications with a new 510(k) clearance that enables the company to press on with its pipeline of applications.

AAOS is as good a place as any to draw attention to one’s products and Integra has taken the opportunity to remind us just how successful its IPP-ON PIP Fusion device has been as it announces reaching 4000 hammertoe correction cases.

If you’re of a certain vintage, if your bones are osteoporotic and you suffer a hip fracture, you are at risk of suffering one on the other side. In a piece of potentially smart-thinking a Bordeaux company has a minimally invasive device that might protect you against that eventuality.

It’s AAOS week, and Mitek Sports Medicine has chosen the event for the launch of the MILAGRO® Advance Interference Screw, a new biocomposite screw designed to offer easier and faster insertion when compared to traditional interference screws.

GelrinC is the first synthetic implant to be CE-approved that is said to provide a customised solution by completely filling cartilage lesions with acellular material. GelrinC is claimed to allow high quality cartilage to regenerate in the knee in the exact shape of the defect.