510(k) · Cleared
ClearedCoreLink F3D™ Lateral 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 Dec 19, 2018 as substantially equivalent to K162496 (Corelink, LLC, 2017) and 1 other predicate after a 29-day review. Its family tree reaches back 17 generations to 1984. 8 later devices descend from it.
- Decided
- Dec 19, 2018
- Review
- 29 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. 8 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 deviceK183239 CoreLink F3D™ Lateral SystemCorelink, LLC · 2018
- Descendant · cites it directly · 3 of its ownK231743 F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody…Corelink, LLC · 2023
- Descendant · cites it directly · 2 of its ownK220523 restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D · 2022
- Descendant · 2 generations on · 1 of its ownK241487 Interwedge® Standalone LateralFoundation Surgical Group, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK261809 Interwedge® Standalone LateralFoundation Surgical Group · 2026
- Descendant · 2 generations on · 0 of its ownK232256 Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024
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 deviceK183239 CoreLink F3D™ Lateral SystemCorelink, LLC · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC · 2023 · cites it directly3descendants
- K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D · 2022 · cites it directly2descendants
- K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc. · 2024 · 2 generations on1descendant
- K261809Interwedge® Standalone LateralFoundation Surgical Group · 2026 · 3 generations on0descendants
- K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024 · 2 generations on0descendants
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) | K183239 | CoreLink F3D™ Lateral System | Corelink, LLC | 2018 | — |
| +1 | K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and… | Corelink, LLC | 2023 | — |
| +1 | K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | Restor3D | 2022 | — |
| +2 | K241487 | Interwedge® Standalone Lateral | Foundation Surgical Group, Inc. | 2024 | — |
| +3 | K261809 | Interwedge® Standalone Lateral | Foundation Surgical Group | 2026 | — |
| +2 | K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | 2024 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2026 | 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…21 CFR §888.3080 Class: II Product Codes: MAX Primary Predicate Device: CoreLink Foundation 3D Interbody System (K162496) Additional Predicate Device: Foundation Lateral Interbody System (K150847) Indications for Use: The F3D™ Lateral System is ind… | 2017 |
| * | K150847 | Foundation Interbody DevicesSummary page 4…odes: MAX Primary Predicate Device: CoreLink Foundation 3D Interbody System (K162496) Additional Predicate Device: Foundation Lateral Interbody System (K150847) Indications for Use: The F3D™ Lateral System is indicated for intervertebral body fusion procedures in skeletally mature patien… | 2015 |
What descends from it? (8)
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 1.6 years on median.
- 23 of the 170 ancestors have a recall of any class.
- Of its descendants, K231743 (Corelink, LLC, 2023) has gone furthest, with 3 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?
The F3D™ Lateral System is 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 L.2-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 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/K183239 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183239: CoreLink F3D™ Lateral System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183239
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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