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FDA clears Biomet’s hip implant | Regulatory roundup

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Clearances roundup

Biomet Inc. received FDA 510(k) clearance for its new hip replacement device.

Warsaw, Ind.-based company said its Active Articulation E1 dual mobility hip system is an implant option for orthopedic surgeons performing hip replacement surgery.

The "dual mobility" design "utilizes a small femoral head that articulates within polyethylene. The large polyethylene bearing, when triggered, acts as a large head bearing that articulates within a metal cup," according to the company.

"The [system] provides an excellent combination of wear resistance and implant stability," Biomet U.S. orthopedics division president Jon Serbousek said in prepared remarks.

The company is competing against the likes of Stryker Corp. (NYSE:SYK) and Zimmer Holdings Inc. (NYSE:ZHM), whose hip implants orthopedic surgeons gave high marks to in a recent survey.

Biomet reported losses of $11.6 million on sales of $678.0 million during the three months ended Feb. 28 — the company’s third quarter. That compares with losses $3.1 million on sales of $669.8 million during the same period ending February 28, 2010.

Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.

  • K2M wins 510(k) for Everest spinal system
    K2M Inc. received 510(k) clearance from the FDA to market the EVEREST Degenerative Spinal System, a versatile top-loading polyaxial pedicle screw system featuring the ability to accommodate multiple levels of fixation rigidity to help surgeons individualize patient care. The system provides for both titanium and cobalt chrome rods of two different diameters, 5.5 and 6.0 mm, limiting inventory and increasing adaptability.
    Read more

  • Biotronik lands FDA approval for Evia pacemaker portfolio expansion
    BIOTRONIK announced FDA approval of the new Estella and Effecta pacemakers, as well as advanced new features and technologies for the Evia pacemaker family.
    Read more

  • Acousticon wins FDA clearance for hearing aid tech
    A new all-in-one hearing aid fitting system received 510(k) clearance. Acousticon, the Durham, N.C.-based American subsidiary of German firm Acousticon GmbH, announced that the FDA cleared its ACAM-5 system. ACAM-5 combines hardware and software into a system that helps audiologists understand the severity of a patient’s hearing loss and optimize the fit of a hearing aid to the hearing needs of each patient, reports MedCity News.
    Read more

  • Sound Surgical wins FDA clearance for fat removal system
    Sound Surgical Technologies announced that the PowerX Lipo System has been cleared for use by the FDA. A new power-assisted liposuction device, the PowerX System combines a rotational handpiece and multiple user settings to allow physicians to utilize the system for different body contouring applications – from gentle, superficial work to more aggressive, large volume fat removal.
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  • FDA approves updated indication for Si-Bone’s iFuse implant
    SI-BONE Inc., a medical device company that is pioneering the use of a minimally invasive surgical (MIS) device to treat the sacroiliac (SI) joint announced the FDA approved a major modification to the existing product label. The Approval targets the use of iFuse Implant System for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. FDA-OSDB worked with SI-BONE Inc. to arrive at a more accurate description of the intended use of the iFuse System, the company said.
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  • Varian wins Chinese approval for image-guided cancer treatment system
    Varian Medical Systems Inc. (NYSE:VAR) announced that the Chinese State Food and Drug Administration (SFDA) has approved its TrueBeam system for image-guided radiotherapy. TrueBeam is a fully-integrated system designed from the ground up to treat tumors with great speed and accuracy — including tumors that move during treatment as the patient breathes in and out.
    Read more

  • VeraLight wins Health Canada licence approval for diabetes screening device
    VeraLight Inc. announced its Scout DS device was granted a Health Canada Medical Device Licence for non-invasive diabetes screening. The device needs no blood and does not require fasting. The patient simply places their forearm onto the portable table-top unit and a quantitative result is reported in about three minutes.
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  • MedShape wins CE Mark certification for soft tissue fixation devices
    MedShape Solutions Inc., the industry leader in innovative shape memory orthopedic devices, announced that it has been notified of CE Mark approval for the Morphix Anchor and the ExoShape Interference Fixation Device. The company has begun discussions with third party distributors across the region.
    Read more

  • Reverse Medical wins 510(k) clearance for distal intracranial catheter
    Reverse Medical Corp. received FDA 510(k) clearance to market the ReFlex line of intracranial catheters for distal neurovascular access and microcatheter therapeutic delivery. The ReFlex Catheter is uniquely designed to provide endovascular intracranial access during interventional neurovascular procedures.
    Read more

  • Guided Therapeutics FDA meeting on PMA for cervical cancer test "productive"
    Guided Therapeutics Inc. (OTC:GTHP), announced that it held a productive meeting with FDA officials to review the company’s pre-market approval application (PMA) for its non-invasive test for the early detection of cervical pre-cancer. During the meeting with FDA reviewers, which was requested by Guided Therapeutics, company representatives outlined proposed responses to recent FDA questions regarding the PMA application and also held discussions regarding proposed claims for use for the technology.
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  • Japanese firm’s Alzheimer’s skin patch falls short of FDA approval
    Eisai Co. Ltd. (TYO:4523) announced that its partner Teikoku Pharma USA Inc. received a Complete Response Letter from the FDA concerning the New Drug Application (NDA) it submitted for a transdermal patch formulation of Aricept (donepezil hydrochloride). The FDA issues a Complete Response Letter to indicate the review cycle of an application is complete and there are still requirements to be fulfilled. The requirements of FDA are mainly formulation and usage　Eisai and Teikoku USA will work with FDA to assess the Complete Response Letter and determine next steps.
    Read more

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