Spinal Resources’ FDA Clearance of Swedge Pedicle Screw

By Julie A. Vetalice

At the end of 2Q17, Spinal Resources (SRI) received FDA 510(k) clearance to market the Swedge™ Pedicle Screw, indicated for use with a 5.5mm rod. Clearances are pending for 4.75mm and 5.0mm rods.

Spinal Resources' system accommodates multiple rods in a single-screw tulip with a one-step locking cap, and effectively locks the tulip's angle without the presence of a rod. A transition rod gradually tapers between sections, minimizing stress risers.

This is SRI's second FDA-cleared product, following an S-wire that received clearance in 1Q16. The company owns four U.S. patents; Swedge is the first of four products in its development pipeline.

Source: Spinal Resources, Inc.


Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory