# K190959: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jul 3, 2019 after 82 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: 20 generations back to K841189 (1984). 305 ancestors in all.
108 later devices descend from it; 7 cite it directly.
1 of 414 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 4.

## Most influential descendants
- K192018: Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device (2019), 102 descendants of its own
- K191581: Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device (2020), 81 descendants of its own
- K201267: Adaptix Interbody System with Titan nanoLOCK Surface Technology (2020), 79 descendants of its own
- 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 (2021), 75 descendants of its own
- K210425: Catalyft PL Expandable Interbody System (2021), 56 descendants of its own

## Indications for use
The ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DOD - 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-S1). Additionally, the ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology can be used in 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. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. When used as an interbody fusion device, these implants are intended for use with supplemental internal fixation systems. The ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DOD - 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-S1). Additionally, the ARTiC-XL™ 3D Ti Spinal System with TiONIC TM technology can be used in 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. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.

Source page: https://510kreport.com/device/K190959
Methodology: https://510kreport.com/methodology