510(k) · Cleared
ClearedFoundation Interbody Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corelink, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Aug 13, 2015 as substantially equivalent to K073440 (Corelink, LLC, 2008) and 7 other predicates after a 135-day review. Its family tree reaches back 13 generations to 1984. 29 later devices descend from it.
- Decided
- Aug 13, 2015
- Review
- 135 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 13 generations to K841189 (1984). 88 ancestors in all. 29 later devices descend from it, 4 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 2 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 1 generation backK133216 Crescent Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- This deviceK150847 Foundation Interbody DevicesCorelink, LLC · 2015
- Descendant · cites it directly · 18 of its ownK180814 CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC · 2018
- Descendant · 2 generations on · 10 of its ownK192492 EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC · 2020
- Descendant · cites it directly · 8 of its ownK183239 CoreLink F3D™ Lateral SystemCorelink, LLC · 2018
- Descendant · 3 generations on · 5 of its ownK222554 EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023
- Descendant · cites it directly · 5 of its ownK180556 Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC · 2018
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 3 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 2 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 1 generation backK133216 Crescent Spinal SystemMedtronic Sofamor Danek, Inc. · 2013
- This deviceK150847 Foundation Interbody DevicesCorelink, LLC · 2015
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC · 2018 · cites it directly18descendants
- K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC · 2020 · 2 generations on10descendants
- K183239CoreLink F3D™ Lateral SystemCorelink, LLC · 2018 · cites it directly8descendants
- K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023 · 3 generations on5descendants
- K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC · 2018 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −3 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −2 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −1 | K133216 | Crescent Spinal System | Medtronic Sofamor Danek, Inc. | 2013 | — |
| 0 (this device) | K150847 | Foundation Interbody Devices | Corelink, LLC | 2015 | — |
| +1 | K180814 | CoreLink® M3™ Stand-Alone Anterior Lumbar System | Corelink, LLC | 2018 | — |
| +2 | K192492 | EL CAPITAN Anterior Lumber Interbody System | Astura Medical, LLC | 2020 | — |
| +1 | K183239 | CoreLink F3D™ Lateral System | Corelink, LLC | 2018 | — |
| +3 | K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | Astura Medical | 2023 | — |
| +1 | K180556 | Corelink Foundation 3D Anterior Lumbar System | Corelink, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 12 | 0 |
| 2005 | 11 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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? (8)
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 |
|---|---|---|---|
| * | K073440 | Foundation CageSummary page 4…MAX CFR Section 21 CFR section 888.3080 Device Panel Orthopedic Primary Predicate Foundation™ Interbody Devices - K073440 Device Amendia (Verticor) Zeus Cage - K081614 DePuy Bengal - K081917 Secondary… | 2008 |
| * | K081614 | Zeus Small Cervical Cage and Large, Extra Large, Curved and Straight Lumbar CagesSummary page 4…Orthopedic Primary Predicate Foundation™ Interbody Devices - K073440 Device Amendia (Verticor) Zeus Cage - K081614 DePuy Bengal - K081917 Secondary Predicate Medtronic Verte-Stack Crescent - K094025, K133216 Device… | 2008 |
| * | K081917 | Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsSummary page 4…Foundation™ Interbody Devices - K073440 Device Amendia (Verticor) Zeus Cage - K081614 DePuy Bengal - K081917 Secondary Predicate Medtronic Verte-Stack Crescent - K094025, K133216 Devices Lanx Timberline - K073144… | 2009 |
| * | K094025 | Crescent Spinal SystemSummary page 4…Amendia (Verticor) Zeus Cage - K081614 DePuy Bengal - K081917 Secondary Predicate Medtronic Verte-Stack Crescent - K094025, K133216 Devices Lanx Timberline - K073144 Eminent Spine Cottonmouth - K090064… | 2010 |
| * | K133216 | Crescent Spinal SystemSummary page 4…Amendia (Verticor) Zeus Cage - K081614 DePuy Bengal - K081917 Secondary Predicate Medtronic Verte-Stack Crescent - K094025, K133216 Devices Lanx Timberline - K073144 Eminent Spine Cottonmouth - K090064… | 2013 |
| * | K073144 | Lanx Intervertebral Body Fusion DeviceSummary page 4…614 DePuy Bengal - K081917 Secondary Predicate Medtronic Verte-Stack Crescent - K094025, K133216 Devices Lanx Timberline - K073144 Eminent Spine Cottonmouth - K090064 Tyber Medical PLIF - K130573… | 2008 |
| * | K090064 | Eminent Spine Interbody Fusion SystemSummary page 4…Predicate Medtronic Verte-Stack Crescent - K094025, K133216 Devices Lanx Timberline - K073144 Eminent Spine Cottonmouth - K090064 Tyber Medical PLIF - K130573 The Foundation™ Interbody Devices are implants… | 2009 |
| * | K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifSummary page 4…25, K133216 Devices Lanx Timberline - K073144 Eminent Spine Cottonmouth - K090064 Tyber Medical PLIF - K130573 The Foundation™ Interbody Devices are implants developed for the substitution… | 2013 |
What descends from it? (29)
See all 294 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 31 years and passes through 11 companies; a new generation was cleared every 1.7 years on median.
- 12 of the 88 ancestors have a recall of any class.
- Of its descendants, K180814 (Corelink, LLC, 2018) has gone furthest, with 18 descendants of its own.
- 4 other devices also cite its predicate K073440.
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. 2015, 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?
Foundation™ Cervical Interbody Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation™ Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior…
Read the full statement (203 words)
Foundation™ Cervical Interbody Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation™ Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation Cervical implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage
The Foundation™ Lumbar Interbody Devices are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ Lumbar implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
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/K150847 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150847: Foundation Interbody Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150847
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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