# K143683: APEX-DL Spine System - Pathway: 510(k) (Traditional) - Applicant: Spinecraft, LLC - Decided: May 22, 2015 after 149 days - Product code: NKB (Thoracolumbosacral Pedicle Screw System) - Device class: 2 - Regulation: 21 CFR 888.3070 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 12 generations back to K990745 (1999). 201 ancestors in all. 3 later devices descend from it; 2 cite it directly. 0 of 205 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K142185: Expedium Verse Spine System, Depuy Spine, Inc. (2014) Summary page 4. - K090648: Viper 2 System, Depuy Spine, Inc. (2009) Summary page 4. - K102701: Viper Spine System, Depuy Spine, Inc. (2010) Summary page 4. - K062513: Apex Spine System, Spinecraft, Inc. (2006) Summary page 4. - K092825: Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer, Spinecraft, Inc. (2010) Summary page 4. - K102488: Apex Spine System W/ Cocr Rods, Spinecraft, LLC (2010) Summary page 4. - K110906: Apex Spine System, Spinecraft, LLC (2011) Summary page 4. - K132603: Apex Spine System, Spinecraft, LLC (2013) Summary page 4. - K113666: Xia 3 Spinal System, Stryker Spine (2012) Summary page 4. - K071373: Stryker Spine Xia Iii Spinal System, Stryker Spine (2007) Summary page 4. - K060748: Modification to Xia 4.5 Spinal System, Stryker Spine (2006) Summary page 4. - K980288: Spine-Tech Silhouette Spinal Fixation System, Spine-Tech, Inc. (1998) Summary page 4. - K950697: Depuy Motech Moss Miami Spinal System - Pedicle Fixation, Depuy Motech (1995) Summary page 4. - K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 4. - K940631: Cross Medical - Synergy (TM) Spine System, Cross Medical Products, Inc. (1995) Summary page 4. - K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 4. - K081252: Expedium 4.5MM Spine System, Depuy Spine, Inc. (2008) Summary page 4. ## Most influential descendants - K234048: M.U.S.T. Pedicle Screw System - Extension (2024), 1 descendant of its own - K253940: M.U.S.T. Pedicle Screw System - Extension (2026), 0 descendants of its own - K211935: ORIO-Ti Intervertebral Body Fusion Cage System (2021), 0 descendants of its own ## Indications for use The APEX-DL Spine System with APEX Spine System Components is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis). The APEX-DL Spine System with APEX Spine System Components is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained. The APEX-DL Spine System with APEX Spine System Components is also a sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis). When used in a percutaneous posterior approach with AIM MIS instrumentation, the APEX-DL Spine System with APEX Spine System Components is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the APEX-DL Spine System implants with APEX Spine System Components are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The APEX DL Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Source page: https://510kreport.com/device/K143683 Methodology: https://510kreport.com/methodology