# K212524: Anteralign Spinal System with Titan nanoLOCK Surface Technology - Pathway: 510(k) (Traditional) - Applicant: Medtronic Sofamor Danek USA, Inc. - Decided: Dec 8, 2021 after 119 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: 28 generations back to K841189 (1984). 596 ancestors in all. 55 later devices descend from it; 4 cite it directly. 1 of 652 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - 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. - K201267: Adaptix Interbody System with Titan nanoLOCK Surface Technology, Medtronic Sofamor Danek (2020) Summary page 5. - K151128: CAPSTONE Spinal System, CLYDESDALE Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5. - K132897: Clydesdale Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 5. - K133577: Clydesdale (R) Spinal System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5. - K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 5. - K123027: Capstone (R) Spinal System, Medtronic Sofamor Danek, Inc. (2013). Our reading of the summary gave K123047, FDA’s number for Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line… (Bracco Diagnostic, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Capstone™ Spinal System”. - K091813: Intrepid Spinal System, Medtronic Sofamor Danek (2009) Summary page 6. - K152277: PIVOX (tm) Oblique Lateral Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 6. - K210425: Catalyft PL Expandable Interbody System, Medtronic Sofamor Danek USA, Inc. (2021) Summary page 6. - K190959: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology, Medtronic Sofamor Danek USA, Inc. (2019) Summary page 6. ## Most influential descendants - K214010: Anteralign Spinal System with Titan nanoLOCK Surface Technology (2022), 49 descendants of its own - 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 ## 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. These implants may be implanted via a minimally invasive OLIF or minimally invasive or open DLIF approach. The Anteralign Spinal System 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 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. Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems. Navigated surgical instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses described on the label and the instruments. Source page: https://510kreport.com/device/K212524 Methodology: https://510kreport.com/methodology