510(k) · Cleared
ClearedIntess Cervical Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kalitec Direct, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Apr 16, 2014 as substantially equivalent to K073351 (Spinal Elements, Inc., 2008) and 3 other predicates after a 121-day review. Its family tree reaches back 10 generations to 1984. 4 later devices descend from it.
- Decided
- Apr 16, 2014
- Review
- 121 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K841189 (1984). 31 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- This deviceK133815 Intess Cervical Cage SystemKalitec Direct, LLC · 2014
- 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
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 4 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- This deviceK133815 Intess Cervical Cage SystemKalitec Direct, LLC · 2014
Most influential descendants
Showing 4 of 4 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −4 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −3 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −2 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −1 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| 0 (this device) | K133815 | Intess Cervical Cage System | Kalitec Direct, LLC | 2014 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 ODP? 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? (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 |
|---|---|---|---|
| * | K073351 | CrystalSummary page 1…CFR section: 21 CFR section 888.3080 Device panel: Orthopedic Legally Marketed Spinal Elements, Crystal Cervical Cage (K073351) Predicate Device: Zimmer, BAKIC Vista Interbody Fusion (P980048 S3) LDR Spine Cerv… | 2008 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…e panel: Orthopedic Legally Marketed Spinal Elements, Crystal Cervical Cage (K073351) Predicate Device: Zimmer, BAKIC Vista Interbody Fusion (P980048 S3) LDR Spine Cervical Interbody Fusion System (K091088) Daytona… | 2001 |
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 1…e (K073351) Predicate Device: Zimmer, BAKIC Vista Interbody Fusion (P980048 S3) LDR Spine Cervical Interbody Fusion System (K091088) Daytona Anterior Cervical Cage System (K1 10733) Submitter: Kalitec Direc… | 2009 |
| * | K110733 | Daytona Anterior Cervical CageSummary page 1…(P980048 S3) LDR Spine Cervical Interbody Fusion System (K091088) Daytona Anterior Cervical Cage System (K1 10733) Submitter: Kalitec Direct, LLC 618 E. South Street, Suite 500… | 2011 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182210 | TiWAVE-L Porous Titanium Lumbar Cage | 2019 | 3 |
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 30 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 31 ancestors have a recall of any class.
- Of its descendants, K182210 (Kalitec Medical, LLC, 2019) has gone furthest, with 3 descendants of its own.
- 26 other devices also cite its predicate K073351.
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. 2014, 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 INTESSTM Cervical Cage is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133815: Intess Cervical Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133815
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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