510(k) · Cleared
ClearedLDR Spine Cervical Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ldr Spine USA · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jul 14, 2009 as substantially equivalent to P980048 (Sulzer Spine-Tech, 2001) and 3 other predicates after a 90-day review. Its family tree reaches back 9 generations to 1984. 1 of the 929 devices in its family, counting itself, has a Class I recall. 901 later devices descend from it.
- Decided
- Jul 14, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K841189 (1984). 27 ancestors in all. 901 later devices descend from it, 51 citing it directly. 1 of the 929 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 2 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 1 generation backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- This deviceK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- Descendant · cites it directly · 454 of its ownK123206 Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013
- Descendant · 2 generations on · 453 of its ownK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
- Descendant · 3 generations on · 449 of its ownK142050 Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated · 2014
- Descendant · 3 generations on · 444 of its ownK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
- Descendant · 3 generations on · 441 of its ownK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 3 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 2 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 1 generation backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- This deviceK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
Showing 5 of 901 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 901 · See all- K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013 · cites it directly454descendants
- K140003Coroent Small Interbody SystemNuvasive, Inc. · 2014 · 2 generations on453descendants
- K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated · 2014 · 3 generations on449descendants
- K140921Coroent Small Interbody SystemNu Vasive, Incorporated · 2014 · 3 generations on444descendants
- K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015 · 3 generations on441descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −3 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −2 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −1 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| 0 (this device) | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| +1 | K123206 | Maxim Surgical X-Treme Interbody Fusion System | Maxim Surgical | 2013 | — |
| +2 | K140003 | Coroent Small Interbody System | Nuvasive, Inc. | 2014 | — |
| +3 | K142050 | Nuvasive Coroent Small Contoured Interbody System | Nu Vasive, Incorporated | 2014 | — |
| +3 | K140921 | Coroent Small Interbody System | Nu Vasive, Incorporated | 2014 | — |
| +3 | K150362 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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 |
|---|---|---|---|
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 1…Predicate devices include several recently down classified cages, as well as cleared VBR systems: - BAK/C (P980048, Zimmer Spine, Approved 4/20/01) - Affinity Cage System (P000028, Med… | 2001 |
| * | P000028 | Affinity (TM) Cage SystemSummary page 1…tems: - BAK/C (P980048, Zimmer Spine, Approved 4/20/01) - Affinity Cage System (P000028, Medtronic, Approved 6/13/02) - ROI-C VBR (K083857, LDR Spine, Cleare… | 2002 |
| * | K083857 | LDR Spine Roi-C ImplantSummary page 1…/01) - Affinity Cage System (P000028, Medtronic, Approved 6/13/02) - ROI-C VBR (K083857, LDR Spine, Cleared 2/12/09) - MC+ Partial VBR (K043479, LDR Spine,… | 2009 |
| * | K043479 | MC+ Partial VBRSummary page 1…d 6/13/02) - ROI-C VBR (K083857, LDR Spine, Cleared 2/12/09) - MC+ Partial VBR (K043479, LDR Spine, Cleared 6/30/05)… | 2005 |
What descends from it? (901)
See all 90151 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123206 | Maxim Surgical X-Treme Interbody Fusion System | 2013 | 454 |
| K100214 | Cornerstone PSR Cervical Interbody Fusion Device | 2010 | 389 |
| K102606 | Avs Anchor-C Cervical Cage System | 2011 | 384 |
| K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants | 2011 | 383 |
| K100698 | STCC | 2011 | 346 |
| K132999 | Cervical Stand Alone System | 2014 | 281 |
| K122588 | Vusion CS Plus | 2013 | 206 |
| K111123 | Varilift Cervical Interbody Fusion System | 2011 | 196 |
| K152532 | AERO -C Cervical Cage System | 2015 | 145 |
| K103034 | Genesys Spine Interbody Fusion System | 2010 | 137 |
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 25 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 27 ancestors have a recall of any class.
- Of its descendants, K123206 (Maxim Surgical, 2013) has gone furthest, with 454 descendants of its own.
- 53 other devices also cite its predicate P980048.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
When used as an intervertebral body fusion device, the LDR Spine Cervical Interbody Fusion System (ROI-C and MC+ devices) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of…
Read the full statement (190 words)
When used as an intervertebral body fusion device, the LDR Spine Cervical Interbody Fusion System (ROI-C and MC+ devices) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine Cervical Interbody Fusion System implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.
When used as a vertebral body replacement device, the ROI-C and MC+ implants are 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 TI to L5) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091088: LDR Spine Cervical Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091088
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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