510(k) · Cleared
ClearedLDR Spine Roi-C Implant
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 May 29, 2008 as substantially equivalent to K043479 (Ldr Spine USA, 2005) after a 76-day review. Its family tree reaches back 7 generations to 1984. 1 of the 927 devices in its family, counting itself, has a Class I recall. 903 later devices descend from it.
- Decided
- May 29, 2008
- Review
- 76 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K841189 (1984). 23 ancestors in all. 903 later devices descend from it, 1 citing it directly. 1 of the 927 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 5 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 4 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 2 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 1 generation backK043479 MC+ Partial VBRLdr Spine USA · 2005
- This deviceK080728 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 · 2 generations on · 901 of its ownK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- Descendant · 3 generations on · 454 of its ownK123206 Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013
- Descendant · 4 generations on · 453 of its ownK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
- Descendant · 5 generations on · 449 of its ownK142050 Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated · 2014
Showing 5 of 903 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 903 · See all- K083857LDR Spine Roi-C ImplantLdr Spine USA · 2009 · cites it directly902descendants
- K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009 · 2 generations on901descendants
- K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013 · 3 generations on454descendants
- K140003Coroent Small Interbody SystemNuvasive, Inc. · 2014 · 4 generations on453descendants
- K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated · 2014 · 5 generations on449descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −6 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −5 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −4 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −2 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −1 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| 0 (this device) | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| +1 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| +2 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| +3 | K123206 | Maxim Surgical X-Treme Interbody Fusion System | Maxim Surgical | 2013 | — |
| +4 | K140003 | Coroent Small Interbody System | Nuvasive, Inc. | 2014 | — |
| +5 | K142050 | Nuvasive Coroent Small Contoured Interbody System | Nu Vasive, Incorporated | 2014 | — |
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 |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 15 | 0 |
| 2012 | 16 | 0 |
| 2013 | 21 | 0 |
| 2014 | 29 | 0 |
| 2015 | 35 | 0 |
| 2016 | 33 | 0 |
| 2017 | 70 | 0 |
| 2018 | 60 | 0 |
| 2019 | 75 | 0 |
| 2020 | 75 | 0 |
| 2021 | 75 | 1 |
| 2022 | 73 | 0 |
| 2023 | 93 | 0 |
| 2024 | 79 | 0 |
| 2025 | 75 | 0 |
| 2026 | 74 | 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 |
|---|---|---|---|
| * | K043479 | MC+ Partial VBRSummary page 1…per 888.3060 5. Legally Marketed Equivalent Predicate Device LDR Spine MC+ Partial Vertebral Body Replacement System (K043479) LDR Spine USA CONFIDENTIAL 266 a pass… | 2005 |
What descends from it? (903)
See all 9031 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083857 | LDR Spine Roi-C Implant | 2009 | 902 |
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 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 23 ancestors have a recall of any class.
- Of its descendants, K083857 (Ldr Spine USA, 2009) has gone furthest, with 902 descendants of its own.
- 17 other devices also cite its predicate K043479.
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. 2008, 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 ROI-C is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The ROI-C is intended to be implanted in pairs. Supplemental internal fixation is required to properly utilize this system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080728 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080728: LDR Spine Roi-C Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080728
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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