510(k) · Cleared
ClearedSmall Stature Spacers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Spine · MQP Spinal Vertebral Body Replacement Device
Cleared on Jun 25, 2007 as substantially equivalent to K061016 (Ebi, L.P., 2006) after a 228-day review. Its family tree reaches back 1 generation to 2006. 1 of the 495 devices in its family, counting itself, has a Class I recall. 493 later devices descend from it.
- Decided
- Jun 25, 2007
- Review
- 228 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061016 (2006). 493 later devices descend from it, 1 citing it directly. 1 of the 495 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK061016 Ebi Esl Peek-Optima Spine SystemEbi, L.P. · 2006
- This deviceK063393 Small Stature SpacersBiomet Spine · 2007
- Descendant · cites it directly · 492 of its ownK092336 C-Thru Spinal SystemEbi, L.P. · 2009
- Descendant · 2 generations on · 389 of its ownK100214 Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010
- Descendant · 3 generations on · 331 of its ownK111264 Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011
- Descendant · 3 generations on · 324 of its ownK112444 Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 2011
- Descendant · 3 generations on · 281 of its ownK122037 Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion…Medtronic Sofamor Danek, Inc. · 2013
Showing 5 of 493 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 493 · See all- K092336C-Thru Spinal SystemEbi, L.P. · 2009 · cites it directly492descendants
- K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek · 2010 · 2 generations on389descendants
- K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA · 2011 · 3 generations on331descendants
- K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc. · 2011 · 3 generations on324descendants
- K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc. · 2013 · 3 generations on281descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061016 | Ebi Esl Peek-Optima Spine System | Ebi, L.P. | 2006 | — |
| 0 (this device) | K063393 | Small Stature Spacers | Biomet Spine | 2007 | — |
| +1 | K092336 | C-Thru Spinal System | Ebi, L.P. | 2009 | — |
| +2 | K100214 | Cornerstone PSR Cervical Interbody Fusion Device | Medtronic Sofamor Danek | 2010 | — |
| +3 | K111264 | Cornerstone (R) PSR Cervical Fusion System | Medtronic Sofamor Danek USA | 2011 | — |
| +3 | K112444 | Anatomic Peek Cervical Fusion System | Medtronic Sofamor Danck USA, Inc. | 2011 | — |
| +3 | K122037 | Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System… | Medtronic Sofamor Danek, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 10 | 0 |
| 2015 | 8 | 0 |
| 2016 | 13 | 0 |
| 2017 | 27 | 0 |
| 2018 | 19 | 0 |
| 2019 | 33 | 0 |
| 2020 | 31 | 0 |
| 2021 | 50 | 1 |
| 2022 | 47 | 0 |
| 2023 | 54 | 0 |
| 2024 | 62 | 0 |
| 2025 | 63 | 0 |
| 2026 | 60 | 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? (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 |
|---|---|---|---|
| * | K061016 | Ebi Esl Peek-Optima Spine SystemSummary page 1…ion Orthosis, 21 CFR §888.3060 Product Code: MQP Legally Marketed Devices To Which Substantial Equivalence Is Claimed: * ESL® PEEK-OPTIMA® Spine System - K(061016 Device Description: The Small Stature Spacers are comprised of polyetheretherketone (PEEK) and are similar in design to the EBI E… | 2006 |
What descends from it? (493)
See all 4931 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092336 | C-Thru Spinal System | 2009 | 492 |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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. 2007, 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 Small Stature Spacers are indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Small Stature Spacers are also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Small Stature Spacers are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063393 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063393: Small Stature Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063393
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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