510(k) · Cleared
ClearedBasis Vertebral Body Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · MQP Spinal Vertebral Body Replacement Device
Cleared on Jun 9, 2005 as substantially equivalent to K033926 (Medtronic Sofamor Danek, 2004) after a 38-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Jun 9, 2005
- Review
- 38 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K003155 (2001). 11 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 6 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 5 generations backK012254 VBROsteotech, Inc. · 2001
- 4 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 3 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 2 generations backK030736 Verte-Stack Spinal System, Extra Small SizesMedtronic Sofamor Danek · 2003
- 1 generation backK033926 Hourglass Vertebral Body SpacerMedtronic Sofamor Danek · 2004
- This deviceK051105 Basis Vertebral Body SpacerMedtronic Sofamor Danek · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −5 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −4 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −3 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −2 | K030736 | Verte-Stack Spinal System, Extra Small Sizes | Medtronic Sofamor Danek | 2003 | — |
| −1 | K033926 | Hourglass Vertebral Body Spacer | Medtronic Sofamor Danek | 2004 | — |
| 0 (this device) | K051105 | Basis Vertebral Body Spacer | Medtronic Sofamor Danek | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 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 MQP? 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? (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 |
|---|---|---|---|
| * | K033926 | Hourglass Vertebral Body SpacerSummary page 2…ubstantial Equivalence Documentation was provided which demonstrated the BASISTM Spinal System to be substantially equivalent to the following systems: HOURGLASS TM VBS (K033926). t-t~LotlI DEPARTMENT OF… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 11 ancestors has a recall.
- 2 other devices also cite its predicate K033926.
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.
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?
When used as a vertebral body replacement, BASIS™ Vertebral Body Spacers are intended to be used in partial corpectomy procedures to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1-L5) to replace and restore height of a resected vertebral body or portion thereof, excised for the treatment of tumor or trauma (i.e., fracture). BASIS™ Vertebral Body Spacers must be used with supplemental fixation. Additionally, BASIS™ Vertebral Body Spacers are intended to be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051105 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051105: Basis Vertebral Body Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051105
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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