# K172009: Cascadia Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Dec 14, 2017 after 164 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K841189 (1984). 248 ancestors in all.
43 later devices descend from it; 9 cite it directly.
1 of 292 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162264: Cascadia Interbody System, K2m, Inc. (2016) Summary page 4.
- K141665: NuVasive CoRoent System, Nuvasive, Inc. (2015) Summary page 4.

## Most influential descendants
- K181347: Aries® Lumbar Interbodies (2018), 24 descendants of its own
- K213935: PISCES-SA Standalone ALIF Interbody System (2022), 12 descendants of its own
- K182987: Genesys Spine 3DP Lumbar Interbody System (2019), 9 descendants of its own
- K191489: Genesys Spine 3DP Cervical Interbody System (2020), 7 descendants of its own
- K231199: Solar Lumbar Interbody Fusion System (2023), 5 descendants of its own

## Recalls of this device
- May 7, 2021 · Class II · Z-1697-2021: Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
- May 7, 2021 · Class II · Z-1695-2021: Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
- May 7, 2021 · Class II · Z-1696-2021: Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm

## 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 1 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 nsed with supplemental spinal fixation systems that have been cleared for use in the lumbesacral spine. The hyperlordotic CASCADIA lumbar implants (i.e., > 20°) should be used with anterior supplemental fixation (e.g., &n anterior lumbar plate). 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/K172009
Methodology: https://510kreport.com/methodology