# K210425: Catalyft PL Expandable Interbody System - Pathway: 510(k) (Traditional) - Applicant: Medtronic Sofamor Danek USA, Inc. - Decided: May 24, 2021 after 102 days - Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar) - Device class: 2 - Regulation: 21 CFR 888.3080 - Recalls of this device: 1 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 27 generations back to K841189 (1984). 499 ancestors in all. 56 later devices descend from it; 2 cite it directly. 1 of 556 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - 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 5. - K133216: Crescent Spinal System, Medtronic Sofamor Danek, Inc. (2013) Summary page 5. - K171031: CRESCENT™ Spinal System, Medtronic Sofamor Danek (2017) Summary page 5. - K100175: Clydesdale Spinal System, Medtronic Sofamor Danek (2010) 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. - K163581: Navigated ELEVATE Inserter, Navigated Disc Prep Instruments, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 5. - K131425: Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter, Medtronic Navigation, Inc. (2013) Summary page 6. - K150231: Navigated Disc Prep Instruments and CAPSTONE Trials, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 6. - K201267: Adaptix Interbody System with Titan nanoLOCK Surface Technology, Medtronic Sofamor Danek (2020) Summary page 6. ## Most influential descendants - 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 - K223494: CD Horizon Spinal System (2023), 17 descendants of its own - K240368: E3D™-A Interbody System (2024), 7 descendants of its own ## Recalls of this device - Sep 16, 2025 · Class II · Z-0580-2026: Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions ## Indications for use The Catalyft™ PL Expandable Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S 1 ). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. Additionally, the Catalyft™ PL Expandable Interbody System can be used with patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. These implants are intended for use with supplemental internal fixation systems. 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 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/K210425 Methodology: https://510kreport.com/methodology