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Eight important FDA 510(k) clearances to keep your practice up to date

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Orthopedics Today highlights eight recent FDA clearances that could be of benefit to an orthopedic practice.

Maxx Orthopedics receives 510(k) clearance for revision knee system

The FDA issued 510(k) clearance to Maxx Orthopedics Inc. for its Freedom PCK Components. It combines the company’s Freedom Stemmed Tibial Components with patent-pending femoral components and constrained liners, to create a bone-conserving, low-profile revision knee system. Read more.

FDA issues 510(k) clearance for Extremity Medical’s HammerFiX IP fusion device

The FDA granted 510(k) clearance to Extremity Medical LLC for its HammerFiX IP fusion device. The device is used for osteotomy fixation and reconstruction of the lesser toes after hammertoe, claw toe and mallet toe fixation. Read more.

MedShape receives 510(k) clearance for suture anchor

The FDA issued 510(k) clearance to MedShape Inc. for its Morphix SP Suture Anchor. The Morphix SP features the company’s Scoria technology, a polyetheretherketone (PEEK) material manufactured with interconnected micrometer scale surface porosity and based on Zeniva PEEK resin from Solvay Specialty Polymers. Read more.

Shoulder Options gets 510(k) clearance for fracture plate

Shoulder Options Inc. recently announced FDA 510(k) clearance for its AFT Proximal Humerus Fracture Plate. Read more.

Integra LifeSciences receives FDA clearance for titanium bone wedges

The FDA issued 510(k) clearance for Integra LifeSciences’ titanium bone wedges, which are designed for internal fixation of bone fractures or for osteotomies in the foot and ankle. Read more.

Rotation Medical gets 510(k) clearance for implantable collagen scaffold technology

Rotation Medical Inc. received 510(k) clearance for its implantable collagen scaffold technology for treatment of rotator cuff disease. Read more.

Edge Orthopaedics receives 510(k) clearance for compression screws

Edge Orthopaedics received its first FDA 510(k) clearance for their Bite Compression Screws. Read more.

FDA issues 510(k) clearance for bioactive bone graft putty

The FDA issued 510(k) clearance to BioStructures LLC for its Signafuse bioactive one graft putty, which is indicated for the posterolateral spine, extremities and pelvis as well as a bone graft extender in the posterolateral spine. Read more.