510(k) · Cleared
ClearedAscend VBR System, Ascend NanoTec VBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · MQP Spinal Vertebral Body Replacement Device
Cleared on Oct 6, 2023 as substantially equivalent to K192117 (Ulrich GmbH & Co. KG, 2019) and 2 other predicates after a 77-day review. Its family tree reaches back 23 generations to 1984. 1 of the 280 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 6, 2023
- Review
- 77 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 23 generations to K841189 (1984). 279 ancestors in all. No later device cites it as a predicate yet. 1 of the 280 devices in this family, counting this one, has a Class I recall.
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations between
- 3 generations backK172123 NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
- 2 generations backK192760 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2019
- 1 generation backK193506 NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical…Nu Vasive, Incorporated · 2020
- This deviceK232173 Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc. · 2023
Show all 23 generations
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 21 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 20 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 17 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 16 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 13 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 12 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 11 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 10 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 9 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 8 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 7 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 6 generations backK143616 AccuLIF TL and PL CageStryker Corporation · 2015 · Recalled
- 5 generations backK152304 Tritanium PL CageStryker · 2015 · Recalled
- 4 generations backK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
- 3 generations backK172123 NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
- 2 generations backK192760 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2019
- 1 generation backK193506 NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical…Nu Vasive, Incorporated · 2020
- This deviceK232173 Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc. · 2023
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −22 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −21 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −20 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −17 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −16 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −13 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −12 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −11 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −10 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −9 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −8 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −7 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −6 | K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015 | 4 |
| −5 | K152304 | Tritanium PL Cage | Stryker | 2015 | 1 |
| −4 | K163230 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −3 | K172123 | NuVasive® Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −2 | K192760 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2019 | — |
| −1 | K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical… | Nu Vasive, Incorporated | 2020 | — |
| 0 (this device) | K232173 | Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 15 | 0 |
| 2004 | 23 | 0 |
| 2005 | 17 | 0 |
| 2006 | 10 | 0 |
| 2007 | 14 | 0 |
| 2008 | 39 | 1 |
| 2009 | 22 | 0 |
| 2010 | 14 | 0 |
| 2011 | 20 | 0 |
| 2012 | 11 | 0 |
| 2013 | 14 | 0 |
| 2014 | 13 | 0 |
| 2015 | 9 | 0 |
| 2016 | 6 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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 |
|---|---|---|---|
| * | K192117 | Small VBR™Summary page 5…III. LEGALLY MARKETED DEVICES Primary Predicate Device: 510(k) Product Name Clearance Date K192117 Small VBR™ 11/1/2019 Additional Predicate Devices: 510(k)… | 2019 |
| * | K050553 | Novel VBR Spinal SystemSummary page 5…11/1/2019 Additional Predicate Devices: 510(k) Product Name Clearance Date K050553 Novel Spinal Spacer System 04/18/2005 NuVasive X-Core® Expandable VBR System, Nu… | 2005 |
| * | K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemSummary page 5…ce Date K050553 Novel Spinal Spacer System 04/18/2005 NuVasive X-Core® Expandable VBR System, NuVasive K193506 02/26/2020 X-Core® Mini Cervical Expandable VBR Sy… | 2020 |
| † | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™… | 2022 |
| † | K180480 | ATEC Universal Spacer System | 2018 |
| † | K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec… | 2021 |
| † | K161363 | Arsenal Spinal Fixation System | 2016 |
| † | K192938 | Invictus™ Spinal Fixation System | 2019 |
| † | K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 6 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 14 companies; a new generation was cleared every 10 months on median.
- 34 of the 279 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K192117.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The Ascend VBR System is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders. The Ascend VBR System is also intended to restore the…
Read the full statement (319 words)
The Ascend VBR System is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The Ascend VBR 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
The Ascend VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend VBR System is optional.
The Ascend NanoTec VBR System with advanced NanoTec surface treatment is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The Ascend NanoTec VBR 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
The Ascend NanoTec VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend NanoTec VBR System is optional.
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/K232173 · printed Nov 3, 2026
Cite this page
510(k) Report. “K232173: Ascend VBR System, Ascend NanoTec VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K232173
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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