510(k) · Cleared
ClearedneoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ht Medical D.B.A. Xenix Medical · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Sep 1, 2023 as substantially equivalent to K182210 (Kalitec Medical, LLC, 2019) and 2 other predicates after a 338-day review. Its family tree reaches back 23 generations to 1984. 1 of the 322 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Sep 1, 2023
- Review
- 338 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 23 generations to K841189 (1984). 319 ancestors in all, the oldest K792352 (1979). 2 later devices descend from it, 2 citing it directly. 1 of the 322 devices in this family, counting this one, has a Class I recall.
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations between
- 3 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- 2 generations backK172009 Cascadia Interbody SystemK2m, Inc. · 2017 · Recalled
- 1 generation backK182210 TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC · 2019
- This deviceK222988 neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical · 2023
- Descendant · cites it directly · 0 of its ownK252240 Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine · 2026
- Descendant · cites it directly · 0 of its ownK253583 LUX Expandable Lumbar Interbody SystemXenix Medical · 2026
Show all 23 generations
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 21 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 20 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 17 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 16 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 13 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 12 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 11 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 10 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 9 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 8 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 7 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 6 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 5 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 4 generations backK160125 Cascadia Interbody SystemK2m · 2016
- 3 generations backK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- 2 generations backK172009 Cascadia Interbody SystemK2m, Inc. · 2017 · Recalled
- 1 generation backK182210 TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC · 2019
- This deviceK222988 neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical · 2023
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −22 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −21 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −20 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −17 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −16 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −13 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −12 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −11 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −10 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −9 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −8 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −7 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −6 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −5 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −4 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| −3 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| −2 | K172009 | Cascadia Interbody System | K2m, Inc. | 2017 | 3 |
| −1 | K182210 | TiWAVE-L Porous Titanium Lumbar Cage | Kalitec Medical, LLC | 2019 | — |
| 0 (this device) | K222988 | neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical | Ht Medical D.B.A. Xenix Medical | 2023 | — |
| +1 | K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | 2026 | — |
| +1 | K253583 | LUX Expandable Lumbar Interbody System | Xenix Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 17 | 0 |
| 2004 | 24 | 0 |
| 2005 | 16 | 0 |
| 2006 | 11 | 0 |
| 2007 | 16 | 0 |
| 2008 | 45 | 1 |
| 2009 | 28 | 0 |
| 2010 | 16 | 0 |
| 2011 | 22 | 0 |
| 2012 | 13 | 0 |
| 2013 | 17 | 0 |
| 2014 | 13 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182210 | TiWAVE-L Porous Titanium Lumbar CageSummary page 8…er K-Number Primary Predicate Device TiWAVE-L Porous Titanium Lumbar Kalitec Direct, LLC K182210 Cage (TiWAVE-L) Additional Predicate Devices TiWAVE-C™ Porous Titanium… | 2019 |
| * | K180401 | TiWAVE-C™ Porous Titanium Cervical CageSummary page 8…0 Cage (TiWAVE-L) Additional Predicate Devices TiWAVE-C™ Porous Titanium Kalitec Direct, LLC K180401 Cervical Cage (TiWAVE-C) Ti3D Cervical (NeoFuse Cervical) HT Medical, LLC K170318 Perform… | 2018 |
| * | K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical InterbodySummary page 8…Kalitec Direct, LLC K180401 Cervical Cage (TiWAVE-C) Ti3D Cervical (NeoFuse Cervical) HT Medical, LLC K170318 Performance Testing Summary: In consideration of the FDA’s Guidance for Industry: Considering Whether an FDA-Regulated Product… | 2017 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 16 companies; a new generation was cleared every 10 months on median.
- 40 of the 319 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K252240 (Spectrum Spine, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
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…
Read the full statement (352 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222988: neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222988
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026