# K201267: Adaptix Interbody System with Titan nanoLOCK Surface Technology - Pathway: 510(k) (Traditional) - Applicant: Medtronic Sofamor Danek - Decided: Aug 26, 2020 after 106 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: 26 generations back to K841189 (1984). 419 ancestors in all. 79 later devices descend from it; 7 cite it directly. 1 of 499 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 5. - K123027: Capstone (R) Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 5. - K191581: Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device, Titan Spine, Inc. (2020) 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 5. - 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 5. - K142559: ELEVATE Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5. - K094025: Crescent Spinal System, Medtronic Sofamor Danek (2010) Summary page 6. - K151128: CAPSTONE Spinal System, CLYDESDALE Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 6. ## Most influential descendants - K210425: Catalyft PL Expandable Interbody System (2021), 56 descendants of its own - K212524: Anteralign Spinal System with Titan nanoLOCK Surface Technology (2021), 55 descendants of its own - 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 - K201193: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System (2020), 18 descendants of its own ## Indications for use The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These patients should be skeletally mature and have had six months of nonoperative treatment. The Adaptix™ Interbody 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. These implants may be implanted via an open or a minimally invasive posterior approach and/or transforaminal approach. Medtronic Navigated Surgical Instruments are intended to be used during the 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 can be 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, a 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 as described on the label and the instruments. Source page: https://510kreport.com/device/K201267 Methodology: https://510kreport.com/methodology