# K150481: Cascadia Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Aug 20, 2015 after 177 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: 14 generations back to K841189 (1984). 96 ancestors in all.
459 later devices descend from it; 16 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)
- K082698: Aleutian Ibf System, K2m, Inc. (2009) Summary page 4.
- K110843: Aleutian Spacer System, K2m, Inc. (2011) Summary page 4.
- K113138: Aleutian System, K2m, Inc. (2012) Summary page 4.
- K130699: Aleutian Spinal System, K2m, Inc. (2013) Summary page 4.
- K133614: Aleutian Ibf System, K2m, Inc. (2014) Summary page 4.
- K113561: TM Ardis Interbody System TM Ardis Interbody System Instrumenation, Zimmer Trabecular Metal Technology (2012) Summary page 4.
- K112316: 4-Web Alif Spinal Truss System (STS), 4-Web, Inc. (2011) Summary page 4.
- K100945: Fuse Plif Cafe, Advanced Medical Technologies AG (2011) Summary page 4.
- K141405: Mobis II ST Spinal Implant, Signus Medizintechnik GmbH (2014) Summary page 4.

## Most influential descendants
- K160125: Cascadia Interbody System (2016), 315 descendants of its own
- K163230: NuVasive Modulus XLIF Interbody System (2017), 276 descendants of its own
- K172123: NuVasive® Modulus XLIF Interbody System (2017), 227 descendants of its own
- K162264: Cascadia Interbody System (2016), 169 descendants of its own
- K192760: NuVasive Modulus XLIF Interbody System (2019), 163 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 implants are indicated for use with autogenous bone graft as intervertebral body fusion devices in skeletally mature patients. The implants are intended for use at either one level or two contiguous levels, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade | 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/K150481
Methodology: https://510kreport.com/methodology