# K222988: neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical

- Pathway: 510(k) (Traditional)
- Applicant: Ht Medical D.B.A. Xenix Medical
- Decided: Sep 1, 2023 after 338 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: 23 generations back to K841189 (1984). 319 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 322 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182210: TiWAVE-L Porous Titanium Lumbar Cage, Kalitec Medical, LLC (2019) Summary page 8.
- K180401: TiWAVE-C™ Porous Titanium Cervical Cage, Kalitec Direct, LLC (2018) Summary page 8.
- K170318: NeoFuse Ti3D PLIF/TLIF/Cervical Interbody, Ht Medical, LLC (2017) Summary page 8.

## Most influential descendants
- 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 neoWave LS Porous Titanium 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 L2-S 1. 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). neoWave LS Porous Titanium Cage implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft implanted via a transforaminal approach or an open posterior approach. The neoWave LS Porous Titanium 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 The neoWave C Porous Titanium 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. When used as a Cervical Interbody Fusion device, NeoFuse Ti3D is indicated for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to Tl. 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/K222988
Methodology: https://510kreport.com/methodology