510(k) · Cleared
ClearedCorelink Foundation 3D Anterior Lumbar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corelink, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 27, 2018 as substantially equivalent to K162496 (Corelink, LLC, 2017) and 1 other predicate after a 148-day review. Its family tree reaches back 17 generations to 1984. 5 later devices descend from it.
- Decided
- Jul 27, 2018
- Review
- 148 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K841189 (1984). 170 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 2 generations backK151322 Amendia Interbody Fusion DevicesAmendia, Inc. · 2015 · Recalled
- 1 generation backK162496 Foundation 3D InterbodyCorelink, LLC · 2017
- This deviceK180556 Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC · 2018
- Descendant · cites it directly · 2 of its ownK220523 restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D · 2022
- Descendant · 2 generations on · 0 of its ownK234087 restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D · 2024
- Descendant · cites it directly · 0 of its ownK230329 F3D Interbody SystemCorelink, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK223326 Axiom PSR SystemRestor3D · 2023 · Recalled
- Descendant · cites it directly · 0 of its ownK201939 GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz · 2020
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 7 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 6 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 5 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 4 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 3 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 2 generations backK151322 Amendia Interbody Fusion DevicesAmendia, Inc. · 2015 · Recalled
- 1 generation backK162496 Foundation 3D InterbodyCorelink, LLC · 2017
- This deviceK180556 Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC · 2018
Most influential descendants
Showing 5 of 5 · See all- K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D · 2022 · cites it directly2descendants
- K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D · 2024 · 2 generations on0descendants
- K230329F3D Interbody SystemCorelink, LLC · 2023 · cites it directly0descendants
- K223326Axiom PSR SystemRestor3D · 2023 · 2 generations on0descendants
- K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −7 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −6 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −5 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −4 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| −3 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| −2 | K151322 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2015 | 1 |
| −1 | K162496 | Foundation 3D Interbody | Corelink, LLC | 2017 | — |
| 0 (this device) | K180556 | Corelink Foundation 3D Anterior Lumbar System | Corelink, LLC | 2018 | — |
| +1 | K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | Restor3D | 2022 | — |
| +2 | K234087 | restor3d TIDAL Lumbar Interbody Fusion System | Restor3D | 2024 | — |
| +1 | K230329 | F3D Interbody System | Corelink, LLC | 2023 | — |
| +2 | K223326 | Axiom PSR System | Restor3D | 2023 | 1 |
| +1 | K201939 | GAIA Lumbar Interbody Fusion Device (LIFD) Family | Printerprezz | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 12 | 0 |
| 2004 | 15 | 0 |
| 2005 | 14 | 0 |
| 2006 | 4 | 0 |
| 2007 | 12 | 0 |
| 2008 | 25 | 0 |
| 2009 | 13 | 0 |
| 2010 | 8 | 0 |
| 2011 | 8 | 0 |
| 2012 | 5 | 0 |
| 2013 | 9 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K162496 | Foundation 3D InterbodySummary page 4…888.3080 Common Name Interbody Fusion Device Product Code / Panel MAX / Orthopedics Predicate Device Corelink Foundation 3D Interbody – K162496 (Primary Predicate), Corelink Foundation Lumbar Interbody Devices - K150847 S… | 2017 |
| * | K150847 | Foundation Interbody DevicesSummary page 4…Corelink Foundation 3D Interbody – K162496 (Primary Predicate), Corelink Foundation Lumbar Interbody Devices - K150847 Special Controls N/A Purpose of Submission To add additional Anterior Lumbar Interbody Cage… | 2015 |
What descends from it? (5)
3 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 34 years and passes through 13 companies; a new generation was cleared every 1.2 years on median.
- 23 of the 170 ancestors have a recall of any class.
- Of its descendants, K220523 (Restor3D, 2022) has gone furthest, with 2 descendants of its own.
- 9 other devices also cite its predicate K162496.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
Foundation 3D cervical implants 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…
Read the full statement (202 words)
Foundation 3D cervical implants 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 3D Interbody 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.
Foundation 3D lumbar implants 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 implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180556: Corelink Foundation 3D Anterior Lumbar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180556
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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