510(k) · Cleared
ClearedDiscovery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Spine, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Sep 12, 2011 as substantially equivalent to K091088 (Ldr Spine USA, 2009) after a 104-day review. Its family tree reaches back 10 generations to 1984. 1 later device descends from it.
- Decided
- Sep 12, 2011
- Review
- 104 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K841189 (1984). 28 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- This deviceK111484 DiscoveryIntuitive Spine, LLC · 2011
- Descendant · cites it directly · 0 of its ownK210521 DEXA-C Cervical Interbody SystemAurora Spine, Inc. · 2021
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 4 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- This deviceK111484 DiscoveryIntuitive Spine, LLC · 2011
Most influential descendants
Showing 1 of 1 · See all- K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −4 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −3 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −2 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −1 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| 0 (this device) | K111484 | Discovery | Intuitive Spine, LLC | 2011 | — |
| +1 | K210521 | DEXA-C Cervical Interbody System | Aurora Spine, Inc. | 2021 | — |
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 |
|---|---|---|
| 2021 | 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 ODP? 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? (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 |
|---|---|---|---|
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 1…egulation Number: 888.3080 Product Code: ODP Predicate Device: LDR Spine Cervical Interbody Fusion System (K091088) Device Description: The DISCOVERY is a cervical interbertebral body fusion device consisting of teeth on the inferior and sup… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210521 | DEXA-C Cervical Interbody System | 2021 | 0 |
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 27 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K210521 (Aurora Spine, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 50 other devices also cite its predicate K091088.
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. 2011, 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?
The DISCOVERY is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DODD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDID is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111484 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111484: Discovery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111484
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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