# K234087: restor3d TIDAL Lumbar Interbody Fusion System

- Pathway: 510(k) (Special)
- Applicant: Restor3D
- Decided: Jan 22, 2024 after 31 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: 30 generations back to K841189 (1984). 551 ancestors in all.
No later device cites it as a predicate yet.
1 of 552 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220523: restor3d TiDAL Lumbar Interbody Fusion Device, Restor3D (2022) Summary page 5.

## Indications for use
The restor3d lumbar cages are intended to be used as an intervertebral body fusion device with bone graft for use in lumbar spine. They are indicated for use in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels from L2-S1. DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Implants are used to facilitate fusion in the lumbar spine using autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K234087
Methodology: https://510kreport.com/methodology