# K180777: K2M Expandable Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Aug 3, 2018 after 130 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: 21 generations back to K841189 (1984). 284 ancestors in all.
No later device cites it as a predicate yet.
1 of 285 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163364: MOJAVE Expandable Interbody System, K2m (2017) Summary page 4.
- K173025: NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System, Nu Vasive, Incorporated (2018) Summary page 4.

## Indications for use
The K2M Expandable Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The K2M Expandable Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to §1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or twe adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The K2M Expandable Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Source page: https://510kreport.com/device/K180777
Methodology: https://510kreport.com/methodology