# K160547: Cascadia Interbody System

- Pathway: 510(k) (Special)
- Applicant: K2m
- Decided: Mar 24, 2016 after 27 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: 15 generations back to K841189 (1984). 97 ancestors in all.
157 later devices descend from it; 5 cite it directly.
1 of 255 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150481: Cascadia Interbody System, K2m, Inc. (2015) Summary page 4.
- K082698: Aleutian Ibf System, K2m, Inc. (2009) Summary page 4.
- K110843: Aleutian Spacer System, K2m, Inc. (2011) Summary page 4.
- K130699: Aleutian Spinal System, K2m, Inc. (2013) Summary page 4.

## Most influential descendants
- K170676: HD Lumbar Interbody System (2017), 122 descendants of its own
- K171689: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System  with TiONIC Technology (2017), 109 descendants of its own
- K190959: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology (2019), 108 descendants of its own
- K180364: HD LifeSciences Cervical IBFD System (2018), 106 descendants of its own
- K183557: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS 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, Endoskeleton® TA Vertebral Body Replacement (VBR) Device (2019), 104 descendants of its own

## Indications for use
The CASCADIA implants are indicated for use with autgenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use as either one level or two contiguous levels from L2 to S1 for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar implants are intended to be used in patients who have had six months of non-operative treatment. For all the above indications the CASCADIA implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

Source page: https://510kreport.com/device/K160547
Methodology: https://510kreport.com/methodology