Orthopaedics

Maxx Medical has announced that its “Freedom Knee” has recently received Chinese SFDA approval and will shortly be available throughout the country. Freedom Knee is a complete, high-flexion primary knee replacement system specifically engineered to address the need for smaller sized and differently proportioned implants that better support Asian lifestyle and physiology.

Cartiheal, a privately held device company developing an innovative cell-free technology for regenerating hyaline cartilage, has raised up to $10 million which it will use to accelerate the development of Agili-CTM, as well as support ongoing clinical studies.

Stryker has undertaken a voluntarily global recall for its Rejuvenate and ABG II modular-neck stems because of post-marketing surveillance data which suggests a potential risk of what it has termed “fretting and corrosion”.

Wright Medical Group, Inc. has announced the full commercial launch of the ORTHOLOC™ 3Di Reconstruction Plating System for foot and ankle surgery. The system is to be made available this month in both the U.S. and international markets.

According to a press release issued by US Law firm Bernstein Liebhard LLP, FDA has received almost 17,000 adverse event reports from 2000-2011, associated with metal hip implants, such as the DePuy ASR and Pinnacle hip systems. An FDA panel has been in session for two days to discuss the situation.

Corin Group must be doing something right for LARS SA to extend its distribution agreement with the company in terms of both time and territories. Most notably the new deal now encompasses USA, subject to Corin handling the 510(k) submission.

Smith & Nephew had already issued a Field Safety Notice on its R3 metal acetabular liner. Now MHRA has followed up with its issuance of a Medical Device Alert including direction on patient follow-up.

In its newest arthroscopy devices report, Millennium Research Group concludes that, using USA as a benchmark, many procedure areas are underpenetrated in EU. No doubt that’s true, but can we conclude that the gap between the two markets represents a growth opportunity, or is it “just how it is”?

Integra LifeSciences Holdings Corporation has announced that it is to plug a gap in its range by distributing a private label version of the aap Implantate AG stainless headed compression screw system.

KFx Medical Corporation has announced it has received FDA 510(k) clearance for its 5mm AppianFx® Tissue Fixation Anchor, opening the door to the growing foot and ankle tendon fixation market.

Device company Mindray Medical International Limited, is to acquire a controlling stake of Wuhan Dragonbio Surgical Implant Co., Ltd. signalling its intent in the trauma, spine, joint and other surgical products arena.

The completion of the previously announced merger between Johnson & Johnson and Synthes may take place as early as next Thursday, June 14, as clearances are anticipated.

Smith & Nephew is withdrawing a component of one of its all-metal artificial hip systems following a higher than normal level of patient problems with the device. The fact that the recall was provoked by clinical outcome data points to the potential power of implant registries in regulating surgical implants.

Zimmer Holdings Inc chose last week’s EFORT congress at which to launch its Sidus™ Stem-Free Shoulder system which it claims is ideal for patients with early to mid-stage osteoarthritis.

3D Systems Corporation has announced that it has acquired San Francisco start-up Bespoke Innovations™, Inc. Bespoke develops proprietary, integrated scan, design and print technology that is designed to deliver custom fit prosthetics, orthotics and orthopedic devices that improve treatment and lifestyle outcomes.

The big surprise in this new study, published at AANA this week, is that it’s taken so long for researchers to put a figure on the cost savings to be had in saline consumption alone by using an inflow/outflow computer controlled arthroscopic pump rather than inflow only. Maybe its just a sign of the times that it’s even become an issue.