510(k) · Cleared
ClearedIntess Lumbar Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kalitec Direct, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 28, 2013 as substantially equivalent to K071724 (Spinal Elements, Inc., 2007) and 3 other predicates after a 177-day review. Its family tree reaches back 2 generations to 2007. 5 later devices descend from it.
- Decided
- Mar 28, 2013
- Review
- 177 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K071724 (2007). 5 ancestors in all, the oldest P950019 (1996). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK071724 LucentSpinal Elements, Inc. · 2007
- 1 generation backK081968 Modification to LucentSpinal Elements, Inc. · 2008
- This deviceK123100 Intess Lumbar CageKalitec Direct, LLC · 2013
- Descendant · cites it directly · 3 of its ownK182210 TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC · 2019
- Descendant · 2 generations on · 2 of its ownK222988 neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical · 2023
- Descendant · 3 generations on · 0 of its ownK252240 Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine · 2026
- Descendant · 3 generations on · 0 of its ownK253583 LUX Expandable Lumbar Interbody SystemXenix Medical · 2026
- Descendant · cites it directly · 0 of its ownK220902 Navagio Lumbar CageKalitec Medical, LLC · 2022
Most influential descendants
Showing 5 of 5 · See all- K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC · 2019 · cites it directly3descendants
- K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical · 2023 · 2 generations on2descendants
- K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine · 2026 · 3 generations on0descendants
- K253583LUX Expandable Lumbar Interbody SystemXenix Medical · 2026 · 3 generations on0descendants
- K220902Navagio Lumbar CageKalitec Medical, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071724 | Lucent | Spinal Elements, Inc. | 2007 | — |
| −1 | K081968 | Modification to Lucent | Spinal Elements, Inc. | 2008 | — |
| 0 (this device) | K123100 | Intess Lumbar Cage | Kalitec Direct, LLC | 2013 | — |
| +1 | K182210 | TiWAVE-L Porous Titanium Lumbar Cage | Kalitec Medical, LLC | 2019 | — |
| +2 | K222988 | neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical | Ht Medical D.B.A. Xenix Medical | 2023 | — |
| +3 | K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | 2026 | — |
| +3 | K253583 | LUX Expandable Lumbar Interbody System | Xenix Medical | 2026 | — |
| +1 | K220902 | Navagio Lumbar Cage | Kalitec Medical, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 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.
Planning a device in MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K071724 | LucentSummary page 1…CFR section: 21 CFR section 888. Device panel: Orthopedic Lucent Straight Intervertebral Body Fusion Device - K071724/K081968 Legally Marketed BRANTIGAN I/F CAGE - P960025 Predicate Device: RAY THREADED LUMBAR FUSION CA… | 2007 |
| * | K081968 | Modification to LucentSummary page 1…CFR section: 21 CFR section 888. Device panel: Orthopedic Lucent Straight Intervertebral Body Fusion Device - K071724/K081968 Legally Marketed BRANTIGAN I/F CAGE - P960025 Predicate Device: RAY THREADED LUMBAR FUSION CAGE (P950… | 2008 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…panel: Orthopedic Lucent Straight Intervertebral Body Fusion Device - K071724/K081968 Legally Marketed BRANTIGAN I/F CAGE - P960025 Predicate Device: RAY THREADED LUMBAR FUSION CAGE (P950019) Submitter: Dayne Pope… | 1999 |
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 1…rtebral Body Fusion Device - K071724/K081968 Legally Marketed BRANTIGAN I/F CAGE - P960025 Predicate Device: RAY THREADED LUMBAR FUSION CAGE (P950019) Submitter: Dayne Pope Kalitec Direct, LLC… | 1996 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K182210 (Kalitec Medical, LLC, 2019) has gone furthest, with 3 descendants of its own.
- 38 other devices also cite its predicate K071724.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The INTESS Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) of the lumbar spine at one or two contiguous levels from U2-Si. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). INTESS…
Read the full statement (137 words)
The INTESS Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) of the lumbar spine at one or two contiguous levels from U2-Si. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). INTESS Lumbar Cage implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The INTESS 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123100: Intess Lumbar Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123100
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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