510(k) · Cleared
ClearedALTA Anterior Cervical Corpectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astura Medical, LLC · PLR Spinal Vertebral Body Replacement Device - Cervical
Cleared on Oct 24, 2019 as substantially equivalent to K180550 (Nu Vasive, Incorporated, 2018) and 2 other predicates after a 244-day review. Its family tree reaches back 16 generations to 1984. 3 later devices descend from it.
- Decided
- Oct 24, 2019
- Review
- 244 days
- Class
- Class II
- Product code
- PLR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K841189 (1984). 105 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
- 2 generations backK163491 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2017
- 1 generation backK173324 ALTA Anterior Cervical Interbody SpacerAstura Medical · 2018
- This deviceK190426 ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC · 2019
- Descendant · cites it directly · 2 of its ownK233359 DOMINION Expandable Corpectomy SystemAstura Medical · 2024
- Descendant · 2 generations on · 1 of its ownK241468 Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK261810 Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 10 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 9 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 8 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 7 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 6 generations backK123206 Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013
- 5 generations backK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
- 4 generations backK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
- 3 generations backK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
- 2 generations backK163491 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2017
- 1 generation backK173324 ALTA Anterior Cervical Interbody SpacerAstura Medical · 2018
- This deviceK190426 ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC · 2019
Most influential descendants
Showing 3 of 3 · See all- K233359DOMINION Expandable Corpectomy SystemAstura Medical · 2024 · cites it directly2descendants
- K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024 · 2 generations on1descendant
- K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −10 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −9 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −8 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −7 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −6 | K123206 | Maxim Surgical X-Treme Interbody Fusion System | Maxim Surgical | 2013 | — |
| −5 | K140003 | Coroent Small Interbody System | Nuvasive, Inc. | 2014 | — |
| −4 | K140921 | Coroent Small Interbody System | Nu Vasive, Incorporated | 2014 | — |
| −3 | K150362 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2015 | — |
| −2 | K163491 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −1 | K173324 | ALTA Anterior Cervical Interbody Spacer | Astura Medical | 2018 | — |
| 0 (this device) | K190426 | ALTA Anterior Cervical Corpectomy System | Astura Medical, LLC | 2019 | — |
| +1 | K233359 | DOMINION Expandable Corpectomy System | Astura Medical | 2024 | — |
| +2 | K241468 | Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. | 2024 | — |
| +3 | K261810 | Vertiwedge® Intraosseous System | Foundation Surgical Group | 2026 | — |
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 | 7 | 0 |
| 2004 | 16 | 0 |
| 2005 | 9 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 9 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 PLR? 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 PLR device
- #1 K232481 RIGEL™ 3DR Anterior Cervical Corpectomy Systemscore 13.1 · 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? (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 |
|---|---|---|---|
| * | K180550 | NuVasive Monolith Cervical Corpectomy SystemSummary page 4…duct Code PLR CFR Section 21 CFR section 888.3060 Device Panel Orthopedic Primary Predicate NuVasive Monolith Cervical Corpectomy System (K180550) Device Secondary Predicate ALTA Anterior Cervical Interbody Spacer (K160154, K173324) Device Device Description The ALTA An… | 2018 |
| * | K160154 | ALTA Anterior Cervical Interbody SpacerSummary page 4…el Orthopedic Primary Predicate NuVasive Monolith Cervical Corpectomy System (K180550) Device Secondary Predicate ALTA Anterior Cervical Interbody Spacer (K160154, K173324) Device Device Description The ALTA Anterior Cervical Corpectomy Spacer is a vertebral body replacement… | 2016 |
| * | K173324 | ALTA Anterior Cervical Interbody SpacerSummary page 4…Orthopedic Primary Predicate NuVasive Monolith Cervical Corpectomy System (K180550) Device Secondary Predicate ALTA Anterior Cervical Interbody Spacer (K160154, K173324) Device Device Description The ALTA Anterior Cervical Corpectomy Spacer is a vertebral body replacement… | 2018 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233359 | DOMINION Expandable Corpectomy System | 2024 | 2 |
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 35 years and passes through 11 companies; a new generation was cleared every 1.3 years on median.
- 11 of the 105 ancestors have a recall of any class.
- Of its descendants, K233359 (Astura Medical, 2024) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K180550.
How does its category compare?
All PLR devicesPLR Spinal Vertebral Body Replacement Device - Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PLR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLR
69in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLR
No recall names PLR since 2007.
Adverse event reports per year · PLR
1in 2025
MAUDE reports naming product code PLR, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 259 | 0 | 1 |
| 2019 | 5 | 69 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ALTA Anterior Cervical Corpectomy Spacer is indicated for vertebral body replacement in the cervical spine (C3-C7) in skeletally mature patients. The Alta Anterior Cervical Corpectomy Spacer is intended to replace a diseased or damaged vertebral body caused by fracture, osteomyelitis, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The…
Read the full statement (165 words)
The ALTA Anterior Cervical Corpectomy Spacer is indicated for vertebral body replacement in the cervical spine (C3-C7) in skeletally mature patients. The Alta Anterior Cervical Corpectomy Spacer is intended to replace a diseased or damaged vertebral body caused by fracture, osteomyelitis, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190426: ALTA Anterior Cervical Corpectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190426
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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