# K180401: TiWAVE-C™ Porous Titanium Cervical Cage

- Pathway: 510(k) (Traditional)
- Applicant: Kalitec Direct, LLC
- Decided: Jun 14, 2018 after 120 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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). 218 ancestors in all.
5 later devices descend from it; 3 cite it directly.
1 of 224 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170318: NeoFuse Ti3D PLIF/TLIF/Cervical Interbody, Ht Medical, LLC (2017) Summary page 4.
- K160125: Cascadia Interbody System, K2m (2016) Summary page 4.

## Most influential descendants
- K222988: neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical (2023), 2 descendants of its own
- K221138: Titus Titanium Cervical by SAGICO (2023), 1 descendant of its own
- K252240: Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (2026), 0 descendants of its own
- K253583: LUX Expandable Lumbar Interbody System (2026), 0 descendants of its own
- K233191: TotalTi ACDF by SAGICO (2023), 0 descendants of its own

## Indications for use
The TIWAVE-C™ Porous Titanium Cervical Cage is intended for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment prior to treatment with the device. The devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.

Source page: https://510kreport.com/device/K180401
Methodology: https://510kreport.com/methodology