# K214010: Anteralign Spinal System with Titan nanoLOCK Surface Technology - Pathway: 510(k) (Traditional) - Applicant: Medtronic Sofamor Danek USA - Decided: Apr 12, 2022 after 111 days - Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar) - Device class: 2 - Regulation: 21 CFR 888.3080 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 29 generations back to K841189 (1984). 597 ancestors in all. 49 later devices descend from it; 4 cite it directly. 1 of 647 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K212524: Anteralign Spinal System with Titan nanoLOCK Surface Technology, Medtronic Sofamor Danek USA, Inc. (2021) Summary page 5. - K211258: Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System, Medtronic Sofamor Danek USA, Inc. (2021) Summary page 5. - K171689: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 6. - K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 6. - K123027: Capstone (R) Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 6. - P970015: Inter Fix Threaded Fusion Device, Sofamor Danek (1999) Summary page 6. - K094025: Crescent Spinal System, Medtronic Sofamor Danek (2010) Summary page 6. ## Most influential descendants - K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (2022), 28 descendants of its own - K223494: CD Horizon Spinal System (2023), 17 descendants of its own - K240368: E3D™-A Interbody System (2024), 7 descendants of its own - K232097: IdentiTi ALIF Interbody Systems (2023), 7 descendants of its own - K231438: Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System (2023), 7 descendants of its own ## Indications for use Anteralign Spinal System with Titan nanoLOCK ™ Surface Technology System interbody cages with macro-, micro-, and nano- roughened surface textured features are intended to be used in spinal fusion procedures on skeletally mature patients with symptomatic Degenerative Disc Disease (DDD, defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis, at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should have had six months of nonoperative treatment prior to treatment with this device. Additionally, the Anteralign Spinal System with Titan nanoLOCK ™ Surface Technology can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Anteralign Spinal System with Titan nanoLOCK ™ Surface Technology is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or a combination thereof. The Anteralign TL lnterbody must be used with a posterior supplemental internal spinal fixation cleared for use in the lumbar spine. Miniplate and bone screw components are provided as an option for anti-migration for the TL interbody for the lumbosacral levels oblique or lateral above the bifurcation (L2-L5) of the vascular structures. Indications and contraindications of spinal instrumentation systems should be understood by the surgeon The Anteralign Spinal System with Titan nanoLOCK ™ Surface Technology TL interbody may be implanted via a minimally invasive OLIF or minimally invasive or open DLIF approach. The Anteralign ™ LS interbody cage may be used as a stand-alone device or in conjunction with supplemental fixation. The Anteralign LS ™ interbody fusion Device may be inserted via minimally invasive or open anterior or oblique approach at one or two contiguous levels from L2 to S1. These approaches include anterior and oblique. When used as a stand-alone device, the Anteralign ™ LS cage must be used with 3 screws with devices that have standard lordosis (S16 degrees). If the physician chooses to use less than 3 screws or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation (e.g., posterior fixation) must be used. Additionally, cages with lordosis angles greater than 16 ° are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation) Source page: https://510kreport.com/device/K214010 Methodology: https://510kreport.com/methodology