FDA Approval

The Stryker Rejuvenate Modular Hip was submitted to the FDA for approval to market on April 4, 2008 and was approved on June 3, 2008 as a Special 510(k) submission for a line extension of the Stryker Modular Hip System, approved for market on September 13, 2007.

The Rejuvenate line extended the combined head/neck length options for the Rejuvenate and was intended for use with any currently available Howmedica Osteonics acetabular components, V40 femoral heads (CoCr), C-Taper Alumina heads (ceramic) when used with the V40/C-Taper Adaptor and the Biolox Delta (ceramic) Universal Taper Heads and Sleeves.

Stryker received marketing approval for a size extension of the Rejuvenate line on October 20, 2009 for additional combined head/neck length options. The Stryker Modular Hip was the first modular design made by the company. It was approved for market based on substantial similarity to Wright Medical Technology’s Profemur Total Hip Modular Neck System.

According to Stryker itself, the Stryker Rejuvenate Modular Hip and ABG II modular-neck hip stems were first marketed and sold in 2009.

As part of its 510(k) approval, Stryker initiated a prospective clinical study in November 2010, Rejuvenate Modular Outcomes Study. Subjects will be evaluated for freedom of hip revision at 5 years and clinical outcomes for up to 10 years after surgery. The outcomes of this study are not yet available