# K210800: IO Expandable Lumbar Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: Aug 20, 2021 after 157 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: 22 generations back to K841189 (1984). 344 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 347 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192115: SABLE Expandable Spacer, Globus Medical, Inc. (2020) Summary page 4.

## Most influential descendants
- K232292: Peridot-EX Expandable Intervertebral Body Fusion System (2023), 0 descendants of its own
- K231241: NanoHive Medical Lumbar Interbody System (2023), 0 descendants of its own

## Indications for use
The IO™ Expandable Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

Source page: https://510kreport.com/device/K210800
Methodology: https://510kreport.com/methodology