510(k) · Cleared
ClearedHAtetracell™-C Titanium Cervical IBF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasis, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Oct 17, 2023 as substantially equivalent to K220875 (Innovasis, Inc., 2022) after a 111-day review. Its family tree reaches back 17 generations to 1984. 2 later devices descend from it.
- Decided
- Oct 17, 2023
- Review
- 111 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K841189 (1984). 141 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK163491 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2017
- 2 generations backK173030 Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated · 2017
- 1 generation backK220875 HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc. · 2022
- This deviceK231899 HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK262025 Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF…INNO Holdings Inc. DBA Innovasis · 2026
- Descendant · cites it directly · 0 of its ownK250076 Endeavor™ Stand-Alone Cervical IBF SystemInnovasis · 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 backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 11 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 10 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 9 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 8 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 7 generations backK123206 Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013
- 6 generations backK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
- 5 generations backK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
- 4 generations backK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
- 3 generations backK163491 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2017
- 2 generations backK173030 Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated · 2017
- 1 generation backK220875 HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc. · 2022
- This deviceK231899 HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc. · 2023
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 |
|---|---|---|---|---|---|
| −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 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −11 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −10 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −9 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −8 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −7 | K123206 | Maxim Surgical X-Treme Interbody Fusion System | Maxim Surgical | 2013 | — |
| −6 | K140003 | Coroent Small Interbody System | Nuvasive, Inc. | 2014 | — |
| −5 | K140921 | Coroent Small Interbody System | Nu Vasive, Incorporated | 2014 | — |
| −4 | K150362 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2015 | — |
| −3 | K163491 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −2 | K173030 | Vertera Spine Cohere Cervical Interbody Fusion Device | Nu Vasive, Incorporated | 2017 | — |
| −1 | K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF System | Innovasis, Inc. | 2022 | — |
| 0 (this device) | K231899 | HAtetracell™-C Titanium Cervical IBF System | Innovasis, Inc. | 2023 | — |
| +1 | K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF… | INNO Holdings Inc. DBA Innovasis | 2026 | — |
| +1 | K250076 | Endeavor™ Stand-Alone Cervical IBF System | Innovasis | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 11 | 0 |
| 2004 | 15 | 0 |
| 2005 | 12 | 0 |
| 2006 | 3 | 0 |
| 2007 | 9 | 0 |
| 2008 | 19 | 0 |
| 2009 | 12 | 0 |
| 2010 | 1 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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? (1)
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 |
|---|---|---|---|
| * | K220875 | HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemSummary page 4…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K220875 HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System ODP K201614… | 2022 |
| † | K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | 2020 |
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? (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 39 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 13 of the 141 ancestors have a recall of any class.
- Of its descendants, K262025 (INNO Holdings Inc. DBA Innovasis, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K220875.
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 Innovasis HAtetracell™-C Titanium Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The HAtetracell™-C device is to be used with…
Read the full statement (110 words)
The Innovasis HAtetracell™-C Titanium Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.
This device is to be used in patients who have had six weeks of non-operative treatment. The HAtetracell™-C device is to be used with supplemental fixation, such as the Innovasis Oryx® Cervical Plate System. The HAtetracell™-C device is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231899 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231899: HAtetracell™-C Titanium Cervical IBF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231899
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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