510(k) · Cleared
ClearedALTA Anterior Cervical Interbody Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astura Medical · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Feb 27, 2018 as substantially equivalent to K160154 (Astura Medical, 2016) and 2 other predicates after a 130-day review. Its family tree reaches back 15 generations to 1984. 27 later devices descend from it.
- Decided
- Feb 27, 2018
- Review
- 130 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K841189 (1984). 83 ancestors in all. 27 later devices descend from it, 4 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
- 2 generations backK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
- 1 generation backK163491 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2017
- This deviceK173324 ALTA Anterior Cervical Interbody SpacerAstura Medical · 2018
- Descendant · cites it directly · 15 of its ownK182477 Cervical SpacerAdditive Implants, LLC · 2019
- Descendant · 2 generations on · 14 of its ownK193359 SureMAX Family of Cervical SpacersAdditive Implants, Inc. · 2020
- Descendant · 3 generations on · 10 of its ownK202666 CONSTRUX Mini PTC Spacer SystemOrthofix, Inc. · 2020
- Descendant · 3 generations on · 9 of its ownK203342 CONSTRUX Mini Ti Spacer SystemOrthofix, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 6 of its ownK202949 CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc. · 2020
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 9 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 8 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 7 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 6 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 5 generations backK123206 Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013
- 4 generations backK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
- 3 generations backK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
- 2 generations backK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
- 1 generation backK163491 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2017
- This deviceK173324 ALTA Anterior Cervical Interbody SpacerAstura Medical · 2018
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K182477Cervical SpacerAdditive Implants, LLC · 2019 · cites it directly15descendants
- K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc. · 2020 · 2 generations on14descendants
- K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc. · 2020 · 3 generations on10descendants
- K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc. · 2021 · 3 generations on9descendants
- K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc. · 2020 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −9 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −8 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −7 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −6 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −5 | K123206 | Maxim Surgical X-Treme Interbody Fusion System | Maxim Surgical | 2013 | — |
| −4 | K140003 | Coroent Small Interbody System | Nuvasive, Inc. | 2014 | — |
| −3 | K140921 | Coroent Small Interbody System | Nu Vasive, Incorporated | 2014 | — |
| −2 | K150362 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2015 | — |
| −1 | K163491 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2017 | — |
| 0 (this device) | K173324 | ALTA Anterior Cervical Interbody Spacer | Astura Medical | 2018 | — |
| +1 | K182477 | Cervical Spacer | Additive Implants, LLC | 2019 | — |
| +2 | K193359 | SureMAX Family of Cervical Spacers | Additive Implants, Inc. | 2020 | — |
| +3 | K202666 | CONSTRUX Mini PTC Spacer System | Orthofix, Inc. | 2020 | — |
| +3 | K203342 | CONSTRUX Mini Ti Spacer System | Orthofix, Inc. | 2021 | 1 |
| +3 | K202949 | CONSTRUX Mini PEEK Spacer System | Orthofix, Inc. | 2020 | — |
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 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 11 | 0 |
| 2005 | 7 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 9 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K160154 | ALTA Anterior Cervical Interbody SpacerSummary page 4…ion 21 CFR section 888.3080 Device Panel Orthopedic Primary Predicate Device Astura Medical ALTA Anterior Cervical Interbody Spacer (K160154) Additional Predicate SpineFrontier Incorporated, Arena-C HA PEEK Cervical Intervertebral Body Device(s)… | 2016 |
| * | K142026 | Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSummary page 4…erbody Spacer (K160154) Additional Predicate SpineFrontier Incorporated, Arena-C HA PEEK Cervical Intervertebral Body Device(s) Fusion Device (K142026), NuVasive® CoRoent® Small Interbody System (K163491) Device Description The ALTA Anterior… | 2014 |
| * | K163491 | NuVasive CoRoent Small Interbody SystemSummary page 4…rena-C HA PEEK Cervical Intervertebral Body Device(s) Fusion Device (K142026), NuVasive® CoRoent® Small Interbody System (K163491) Device Description The ALTA Anterior Cervical Interbody Spacer was developed as implants… | 2017 |
What descends from it? (27)
See all 274 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 34 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 9 of the 83 ancestors have a recall of any class.
- Of its descendants, K182477 (Additive Implants, LLC, 2019) has gone furthest, with 15 descendants of its own.
- 4 other devices also cite its predicate K160154.
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. 2018, 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 ALTA Anterior Cervical Interbody Spacer is indicated for intervertebral body fusion of the spine in skeletally mature patients. The ALTA Anterior Cervical Interbody Spacer is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173324: ALTA Anterior Cervical Interbody Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173324
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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