510(k) · Cleared
ClearedVentana™ C Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Elements, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on May 19, 2023 as substantially equivalent to K153352 (Spinal Elements, Inc., 2016) and 3 other predicates after a 241-day review. Its family tree reaches back 17 generations to 1984. 1 of the 136 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- May 19, 2023
- Review
- 241 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K841189 (1984). 131 ancestors in all. 4 later devices descend from it, 1 citing it directly. 1 of the 136 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015
- 2 generations backK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017 · Recalled
- 1 generation backK200429 BEE CagesNGMedical GmbH · 2021
- This deviceK222833 Ventana™ C Spinal SystemSpinal Elements, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK240416 Tranquil-C Interbody SystemNexus Spine, LLC · 2024
- Descendant · 2 generations on · 2 of its ownK241467 Stable-C Interbody SystemNexus Spine, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK261279 DeltaNEC Interbody SystemNexus Spine · 2026
- Descendant · 3 generations on · 0 of its ownK243934 Stable-L Lumbar Interbody SystemNexus Spine, LLC · 2025
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 9 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 8 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 7 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 6 generations backK103169 AleuttianK2m, Inc. · 2011
- 5 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 4 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 3 generations backK143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015
- 2 generations backK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017 · Recalled
- 1 generation backK200429 BEE CagesNGMedical GmbH · 2021
- This deviceK222833 Ventana™ C Spinal SystemSpinal Elements, Inc. · 2023
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 4 of 4 · See all- K240416Tranquil-C Interbody SystemNexus Spine, LLC · 2024 · cites it directly3descendants
- K241467Stable-C Interbody SystemNexus Spine, LLC · 2024 · 2 generations on2descendants
- K261279DeltaNEC Interbody SystemNexus Spine · 2026 · 3 generations on0descendants
- K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −9 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −8 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −7 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −6 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −5 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| −4 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| −3 | K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) | 4Web, Inc. | 2015 | — |
| −2 | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT… | Eit Emerging Implant Technologies GmbH | 2017 | 2 |
| −1 | K200429 | BEE Cages | NGMedical GmbH | 2021 | — |
| 0 (this device) | K222833 | Ventana™ C Spinal System | Spinal Elements, Inc. | 2023 | — |
| +1 | K240416 | Tranquil-C Interbody System | Nexus Spine, LLC | 2024 | — |
| +2 | K241467 | Stable-C Interbody System | Nexus Spine, LLC | 2024 | — |
| +3 | K261279 | DeltaNEC Interbody System | Nexus Spine | 2026 | — |
| +3 | K243934 | Stable-L Lumbar Interbody System | Nexus Spine, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 11 | 0 |
| 2004 | 13 | 0 |
| 2005 | 10 | 0 |
| 2006 | 2 | 0 |
| 2007 | 10 | 0 |
| 2008 | 13 | 1 |
| 2009 | 9 | 0 |
| 2010 | 2 | 0 |
| 2011 | 9 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (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 |
|---|---|---|---|
| * | K153352 | Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody SystemSummary page 5…ndications for use, surgical technique, design features, manufacturing methods and raw materials to the following predicate devices: Primary Predicate: Crystal® devices (K153352) Secondary Predicate: Lucent® 3D devices (K203254) Secondary Predicate: BEE Cage (K200429) Secondary Predicate: Atlas Spine – HiJ… | 2016 |
| * | K203254 | Lucent 3D Spinal SystemSummary page 5…tures, manufacturing methods and raw materials to the following predicate devices: Primary Predicate: Crystal® devices (K153352) Secondary Predicate: Lucent® 3D devices (K203254) Secondary Predicate: BEE Cage (K200429) Secondary Predicate: Atlas Spine – HiJAK (K192570) Technological Characteristics The su… | 2021 |
| * | K200429 | BEE CagesSummary page 5…erials to the following predicate devices: Primary Predicate: Crystal® devices (K153352) Secondary Predicate: Lucent® 3D devices (K203254) Secondary Predicate: BEE Cage (K200429) Secondary Predicate: Atlas Spine – HiJAK (K192570) Technological Characteristics The subject device was established as substant… | 2021 |
| * | K192570 | Atlas Spine Expandable Cervical Standalone Interbody SystemSummary page 5…Predicate: Crystal® devices (K153352) Secondary Predicate: Lucent® 3D devices (K203254) Secondary Predicate: BEE Cage (K200429) Secondary Predicate: Atlas Spine – HiJAK (K192570) Technological Characteristics The subject device was established as substantially equivalent to another predicate device cleare… | 2020 |
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 |
|---|---|---|---|
| K240416 | Tranquil-C Interbody System | 2024 | 3 |
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 · 4 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 12 companies; a new generation was cleared every 1.6 years on median.
- 19 of the 131 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K240416 (Nexus Spine, LLC, 2024) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K153352.
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?
Ventana™ C devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Implants are to be implanted via an open, anterior approach for the C2-C3 disc space to the C7-T1 disc space and packed with autograft or allogenic bone graft…
Read the full statement (129 words)
Ventana™ C devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Implants are to be implanted via an open, anterior approach for the C2-C3 disc space to the C7-T1 disc space and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices.
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/K222833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222833: Ventana™ C Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222833
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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