# K220523: restor3d TiDAL Lumbar Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Restor3D
- Decided: Jun 17, 2022 after 114 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: 29 generations back to K841189 (1984). 550 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 553 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201755: WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System, SeaSpine Orthopedics Corporation (2020) Summary page 5.
- K210583: SeaSpine WaveForm™ A Interbody System, SeaSpine Orthopedics Corporation (2021) Summary page 5.
- K162496: Foundation 3D Interbody, Corelink, LLC (2017) Summary page 5.
- K180556: Corelink Foundation 3D Anterior Lumbar System, Corelink, LLC (2018) Summary page 5.
- K183239: CoreLink F3D™ Lateral System, Corelink, LLC (2018) Summary page 5.
- K170851: Anterior Spine Truss System (STS) Interbody Fusion Device, 4Web, Inc. (2017) Summary page 5.
- K153436: LATERAL Spine Truss System, 4Web, Inc. (2016) Summary page 5.
- K143258: PLIF STS, TLIF STS, OLIF STS (Spinal Truss System), 4Web, Inc. (2015) Summary page 5.

## Most influential descendants
- K234087: restor3d TIDAL Lumbar Interbody Fusion System (2024), 0 descendants of its own
- K223326: Axiom PSR System (2023), 0 descendants of its own

## 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/K220523
Methodology: https://510kreport.com/methodology