OrthAlign received Australian Therapeutic Goods Administration approval for its Direct Anterior Approach HipAlign and partial knee arthroplasty UniAlign.
Here are five things to know:
1. DAA HipAlign does not use pre-operative imaging or intraoperative fluoroscopy and is designed to offer enhanced position of cup placement and leg length measurement.
2. U.S. clinical data reveals the DAA HipAlign limits fluoroscopy exposure time by 45 percent.
3. Japanese clinical data indicates cup placement accuracy of ±10 degrees, with at least 95.9 percent confidence.
4. UniAlign pinpoints the "varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection."
5. Stimulated use testing has revealed the technology has resection accuracy of ±2 degrees in the coronal plane, ±3 degrees in the sagittal plane and ±2 mm in depth, with at least 90 percent confidence.