FDA Clears DePuy Synthes’ ALTALYNE Ultra Alignment System

DePuy Synthes,** has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the ALTALYNE Ultra Alignment System for adolescent spinal deformities, such as scoliosis. Designed to address unmet clinical needs related to intraoperative rod flattening, the ALTALYNE Ultra Alignment System offers a 5.5 millimeter profile with 36 percent greater resistance to rod flattening than a standard 6.0-millimeter Cobalt Chromium rod.¹  
 
“For more than 35 years, DePuy Synthes has been committed to developing products to address urgent and unmet clinical needs in the spinal deformity space,” said Russell Powers,*** worldwide president, DePuy Synthes, Spine. “The ALTALYNE Ultra Alignment System was developed based on feedback from pediatric spinal deformity surgeons who told us that intraoperative rod flattening is a significant treatment challenge. With [this] clearance, we can provide surgeons with a new treatment option that uses technologically advanced materials and instrumentation to deliver greater bending yield strength than traditional rods, and most importantly, the potential for better patient outcomes.”

Scoliosis is an abnormal curvature of the spine, and adolescent idiopathic scoliosis (AIS) is the most common spinal deformity in the pediatric population, with worldwide prevalence ranges from 0.47 percent to 12 percent.^{2,3,4, 5, 6, 7} Surgical treatment of AIS traditionally involves three-dimensional correction with rods and fusion of the spine. A significant challenge associated with the surgical treatment of AIS is intraoperative rod flattening, which can hinder achieving and maintaining the desired corrected spinal contour and restored balance that would enable patients to move more efficiently throughout their day-to-day lives.
 
Rods with a higher bending yield strength are more resistant to intraoperative flattening, which means the rods can maintain their customized contour and thereby help surgeons achieve the desired restoration for their patients.⁸  The ALTALYNE Ultra Alignment System can deliver greater bending yield strength in a lower profile through advanced material science that employs a specific Cobalt Chromium alloy.¹ While this alloy has been used previously in spinal wires, the ALTALYNE Ultra Alignment System is the first application of this metal in spinal rods.
 
DePuy Synthes, the Orthopedics Company of Johnson & Johnson, provides a comprehensive orthopedics portfolio that helps heal and restore movement for patients. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, extremities, craniomaxillofacial, spinal surgery and sports medicine, in addition to the VELYS Digital Surgery portfolio, are designed to advance patient care while delivering clinical and economic value to healthcare systems worldwide.  

** DePuy Synthes represents the products and services of DePuy Synthes Products Inc. and its affiliates.  
*** Russell Powers is an employee of Medical Device Business Services Inc.

References
¹ DePuy Synthes. Altalyne Calculation of Rod Bending Yield Strength and Stiffness Memorandum, February 11, 2021. Adaptiv #103782175 Rev. 1.
² US Preventive Services Task Force et al. “Screening for Adolescent Idiopathic Scoliosis: US Preventive Services Task Force Recommendation Statement.” JAMA vol. 319,2 (2018): 165-172. doi:10.1001/jama.2017.19342 
³ Tatar O, Ekinci S, Akpancar S, Turgut H. (2016). Current concepts of adolescent idiopathic scoliosis. Minerva Ortop Traumatol 2016, ;67(3):156-62.
⁴ John P. Horne, R. F. (2014). Adolescent Idiopathic Scoliosis: Diagnosis and Management. Am Fam Physician, 1;89(3):193-198. 
⁵ Konieczny, Markus Rafael et al. “Epidemiology of adolescent idiopathic scoliosis.” Journal of children’s orthopaedics vol. 7,1 (2013): 3-9. doi:10.1007/s11832-012-0457-4Choudhry MN, Ahmad Z, Verma R. “Adolescent Idiopathic Scoliosis”. Open Orthop J. 2016 May 30;10:143-54. doi: 10.2174/1874325001610010143. 
⁶ Sung S, Chae HW, Lee HS, Kim S, Kwon JW, Lee SB, Moon SH, Lee HM, Lee BH. “Incidence and Surgery Rate of Idiopathic Scoliosis: A Nationwide Database Study”. Int J Environ Res Public Health. 2021 Aug 1;18(15):8152. doi: 10.3390/ijerph18158152
⁷ Choudhry MN, Ahmad Z, Verma R. “Adolescent Idiopathic Scoliosis”. Open Orthop J. 2016 May 30;10:143-54. doi: 10.2174/1874325001610010143. 
⁸ DePuy Synthes.  EXPEDIUM® Advance Reduction Derotation System Vertebral Body Derotation Spondylolithesis Reduction Fracture Reduction Surgical Technique. 2018. Adaptiv #103407668 Rev. 1.