# K160125: Cascadia Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: K2m
- Decided: Apr 22, 2016 after 93 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 19 generations back to K841189 (1984). 201 ancestors in all.
315 later devices descend from it; 21 cite it directly.
1 of 517 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.
- K103169: Aleuttian, K2m, Inc. (2011) Summary page 4.
- K133614: Aleutian Ibf System, K2m, Inc. (2014) Summary page 4.
- K133494: Chesapeake Spinal System, K2m, Inc. (2014) Summary page 4.
- K072991: Patriot Spacers: Colonial Acdf, Globus Medical, Inc. (2008) Summary page 4.
- K150362: NuVasive CoRoent Small Interbody System, Nu Vasive, Incorporated (2015) Summary page 4.
- K152304: Tritanium PL Cage, Stryker (2015) Summary page 4.

## Most influential descendants
- K162264: Cascadia Interbody System (2016), 169 descendants of its own
- K171140: Matrixx System (2017), 145 descendants of its own
- K180364: HD LifeSciences Cervical IBFD System (2018), 106 descendants of its own
- K170399: Endoskeleton TO Interbody Fusion Device (IBD) (2017), 105 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 lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine. The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥ 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.

Source page: https://510kreport.com/device/K160125
Methodology: https://510kreport.com/methodology