510(k) · Cleared
ClearedMC+ Partial VBR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ldr Spine USA · MQP Spinal Vertebral Body Replacement Device
Cleared on Jun 30, 2005 as substantially equivalent to K042268 (Ebi, L.P., 2004) and 3 other predicates after a 196-day review. Its family tree reaches back 6 generations to 1984. 1 of the 1,237 devices in its family, counting itself, has a Class I recall. 1,214 later devices descend from it.
- Decided
- Jun 30, 2005
- Review
- 196 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K841189 (1984). 22 ancestors in all. 1,214 later devices descend from it, 18 citing it directly. 1 of the 1,237 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 4 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 3 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 2 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 1 generation backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- This deviceK043479 MC+ Partial VBRLdr Spine USA · 2005
- Descendant · cites it directly · 903 of its ownK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- Descendant · cites it directly · 902 of its ownK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- Descendant · cites it directly · 901 of its ownK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- Descendant · cites it directly · 864 of its ownK100042 Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies · 2010
- Descendant · 2 generations on · 762 of its ownK111512 Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc. · 2011
Showing 5 of 1,214 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 1,214 · See all- K080728LDR Spine Roi-C ImplantLdr Spine USA · 2008 · cites it directly903descendants
- K083857LDR Spine Roi-C ImplantLdr Spine USA · 2009 · cites it directly902descendants
- K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009 · cites it directly901descendants
- K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies · 2010 · cites it directly864descendants
- K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc. · 2011 · 2 generations on762descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −5 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −4 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −3 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −2 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −1 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| 0 (this device) | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| +1 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| +1 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| +1 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| +1 | K100042 | Difusion Technologies Xiphos Interbody Fusion System | Difusion Technologies | 2010 | — |
| +2 | K111512 | Bonebac T-Plif Intervertebral Body Fusion Device System | Thompson Mis, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 18 | 0 |
| 2012 | 26 | 0 |
| 2013 | 34 | 0 |
| 2014 | 53 | 0 |
| 2015 | 64 | 0 |
| 2016 | 69 | 0 |
| 2017 | 106 | 0 |
| 2018 | 101 | 0 |
| 2019 | 95 | 0 |
| 2020 | 94 | 0 |
| 2021 | 86 | 1 |
| 2022 | 83 | 0 |
| 2023 | 106 | 0 |
| 2024 | 106 | 0 |
| 2025 | 82 | 0 |
| 2026 | 78 | 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? (4)
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 |
|---|---|---|---|
| * | K042268 | Ebi Cas Spine Spacer SystemSummary page 1…Product Code(s): MQP 4. Equivalent Predicate Device: LDR Spine USA believes that the MC+ is substantially equivalent to the following: K042268 - EBI CAS Spine Spacer System K043206 - Pioneer Vertebral Spacer K032064 - CPOD / LPOD VBR System K033109… | 2004 |
| * | K043206 | Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) Cleared while this submission was under review Summary page 1…valent Predicate Device: LDR Spine USA believes that the MC+ is substantially equivalent to the following: K042268 - EBI CAS Spine Spacer System K043206 - Pioneer Vertebral Spacer K032064 - CPOD / LPOD VBR System K033109 - Ellys and Aurys VBR Equivalence ca… | 2005 |
| * | K032064 | Theken Cpod/Lpod Vertebral Body Replacement SystemSummary page 1…USA believes that the MC+ is substantially equivalent to the following: K042268 - EBI CAS Spine Spacer System K043206 - Pioneer Vertebral Spacer K032064 - CPOD / LPOD VBR System K033109 - Ellys and Aurys VBR Equivalence can be seen in the design, material compositi… | 2004 |
| * | K033109 | Ellys and Aurys Vertebral Body ReplacementsSummary page 1…y equivalent to the following: K042268 - EBI CAS Spine Spacer System K043206 - Pioneer Vertebral Spacer K032064 - CPOD / LPOD VBR System K033109 - Ellys and Aurys VBR Equivalence can be seen in the design, material composition, surgical technique and intended use.… | 2004 |
What descends from it? (1,214)
See all 1,21418 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080728 | LDR Spine Roi-C Implant | 2008 | 903 |
| K083857 | LDR Spine Roi-C Implant | 2009 | 902 |
| K091088 | LDR Spine Cervical Interbody Fusion System | 2009 | 901 |
| K100042 | Difusion Technologies Xiphos Interbody Fusion System | 2010 | 864 |
| K090064 | Eminent Spine Interbody Fusion System | 2009 | 701 |
| K123206 | Maxim Surgical X-Treme Interbody Fusion System | 2013 | 454 |
| K080971 | Spinesmith Cimplicity Spinal System | 2008 | 406 |
| K092904 | Pathway Ivb/VBR | 2009 | 296 |
| K103034 | Genesys Spine Interbody Fusion System | 2010 | 137 |
| K080572 | LDR Spine Roi-a Implant | 2008 | 113 |
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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K080728 (Ldr Spine USA, 2008) has gone furthest, with 903 descendants of its own.
- 7 other devices also cite its predicate K042268.
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?
The MC+ is indicated for use for partial replacement (i.e.: partial vertebrectomy) of a diseased vertebral body that has been resected or excised due to tumor or trauma/fracture in order to achieve anterior decompression of the spinal chord and neural tissues, and to restore the height of a collapsed vertebral body. The components are intended for use in pairs for use as a partial vertebral body replacement in the thoracolumbar spine (from TI to L5) and are intended for use with supplemental internal fixation such as the Easyspine System to properly utilize this system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043479 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043479: MC+ Partial VBR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043479
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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