In the first of several possible material updates in 2016, FDA released draft guidance outlining new information that companies must include when submitting Ultra High Molecular Weight Polyethylene devices for approval.
FDA's order requires OEMs to submit a premarket approval application for certain metal-on-metal devices, specifically hip joint metal/metal semi-constrained with a cemented acetabular component and hip joint metal/metal semi-constrained with an uncemented acetabular component.
Stryker announced construction of a state-of-the-art additive manufacturing facility to support production of new products across multiple divisions and to set itself apart from its competitors. Leadership cited knee and spine as the first markets in which to focus these additive manufacturing efforts.
One of the fastest-growing markets in orthopaedics is extremities. We asked industry executives to weigh in on trends they see driving the segment. Their responses mirrored industry-wide challenges: price pressures, commoditization and surgeon adoption.
With OMTEC approaching, prepare to meet and validate new business partners with these six tools: requiring ISO certification, requesting a copy of the partner's quality manual, reviewing questionnaires, statistical process control (SPC), process validation and auditing.