AAOS Now, October 2010
Treating spinal compression fractures
New guideline recommends against use of vertebroplasty At their meeting on Sept. 24, 2010, the AAOS Board of Directors approved a new clinical practice guideline on the treatment of osteoporotic spinal compression fractures (Fig. 1). The new guideline includes 11 recommendations, including one that is strongly supported by good quality evidence and one that is supported by fair quality evidence (see Table 1, PDF).
The 510(k) process—It’s not broken, so why “fix” it?
By William M. Mihalko, MD, PhD, with Ammar Al-Saraf, Ali Al-Saraf, and Katherine Sale What changing the 510(k) process means to orthopaedics Chances are, if you implanted an orthopaedic device today, it arrived in the marketplace via the U.S. Food and Drug Administration’s (FDA) 510(k) program (Figure 1). Since 2003, more than 99 percent of all medical devices have been cleared through this pathway, compared to less than 1 percent approved through the premarket approval (PMA) process.