# K231359: RODIN™ Expandable Lumbar Cage System

- Pathway: 510(k) (Special)
- Applicant: Ctl Medical Corporation
- Decided: Jun 9, 2023 after 30 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: 13 generations back to K841189 (1984). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160646: XYcor® Expandable Spinal Spacer System, Alphatec Spine, Inc. (2016) Summary page 4.

## Indications for use
When used as an lntervertebral Body Fusion device, the RODIN Expandable Lumbar Cage System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The RODIN Expandable Lumbar Cage System is intended for use with autograft and with supplemental spinal fixation systems and that have been cleared by the FDA. When used as a Vertebral Body Replacement device, the RODIN Expandable Lumbar Cage System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable partial or total vertebral body due to tumor or trauma (i.e. fracture). VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The RODIN Expandable Lumbar Cage System is intended for use with autograft and/or allograft and with supplemental spinal fixation systems and that have been cleared by the FDA.

Source page: https://510kreport.com/device/K231359
Methodology: https://510kreport.com/methodology