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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-42/
- Published: 2022-03-13T12:00:00.000Z
- Updated: 2026-09-14T17:36:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139433

**DEVICES**

FDA has cleared a **Globus Medical** 510(k) for the Excelsius GPS, a robotic guidance and navigation system for orthopedic (screw placement applications in spine and orthopedic surgery) and neurosurgical procedures. The device integrates Globus Medical implants and instruments and is compatible with pre-operative computed tomography (CT), intra-operative CT and fluoroscopic imaging modalities, according to the company.

FDA has cleared a **Stryker** 510(k) for the Serrato Pedicle Screw, intended for use in the non-cervical spine as part of the company’s Xia 3 Spinal System. The device features serrated cutting flutes, a dual-thread pattern with an increased number of leads for rapid insertion, and a patented buttress thread locking mechanism designed to minimize cross threading and splaying of the screw head, according to the company.

**DRUGS**

FDA has approved an **AstraZeneca** NDA for Lynparza (olaparib) and its use as a maintenance treatment in adults with recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status.

FDA has approved **Wyeth Pharmaceuticals**’ Besponsa (inotuzumab ozogamicin) for treating adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The approval was based on data from INO-VATE ALL (NCT01564784), a randomized (1:1), open label, international, multicenter study in 326 patients with Philadelphia chromosome-negative or Philadelphia chromosome-positive relapsed or refractory B-cell precursor ALL.