# K182210: TiWAVE-L Porous Titanium Lumbar Cage

- Pathway: 510(k) (Traditional)
- Applicant: Kalitec Medical, LLC
- Decided: Jan 7, 2019 after 145 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). 317 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 321 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.
- K162264: Cascadia Interbody System, K2m, Inc. (2016) Summary page 4.
- K172009: Cascadia Interbody System, K2m, Inc. (2017) Summary page 4.
- K172941: CASCADIA Interbody System, K2m (2018) Summary page 4.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 4.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 4.
- K133815: Intess Cervical Cage System, Kalitec Direct, LLC (2014) Summary page 4.
- K123100: Intess Lumbar Cage, Kalitec Direct, LLC (2013) Summary page 4.

## Most influential descendants
- K222988: neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical (2023), 2 descendants 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

## Indications for use
The TiWAVE-L™ Porous Titanium Lumbar Cage 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 L.2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). TIWAVE-L™ Porous Titanium Lumbar Cage implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and implanted via a transforaminal approach or an open posterior approach. The TIWAVE-L™ Porous Titanium Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Source page: https://510kreport.com/device/K182210
Methodology: https://510kreport.com/methodology