510(k) · Cleared
ClearedFoundation 3D Interbody
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 May 4, 2017 as substantially equivalent to K073440 (Corelink, LLC, 2008) and 2 other predicates after a 239-day review. Its family tree reaches back 16 generations to 1984. 82 later devices descend from it.
- Decided
- May 4, 2017
- Review
- 239 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K841189 (1984). 141 ancestors in all. 82 later devices descend from it, 10 citing it directly.
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations between
- 3 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 2 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 1 generation backK151322 Amendia Interbody Fusion DevicesAmendia, Inc. · 2015 · Recalled
- This deviceK162496 Foundation 3D InterbodyCorelink, LLC · 2017
- Descendant · cites it directly · 48 of its ownK183064 TxTi IBF SystemInnovasis, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 47 of its ownK201614 TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 38 of its ownK211805 IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody…Alphatec Spine, Inc. · 2021
- Descendant · 4 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
- Descendant · 4 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
Show all 16 generations
- Root · 16 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 14 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 13 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 10 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 9 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 6 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 5 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 4 generations backK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
- 3 generations backK123045 Brigade Standalone SystemNuvasive, Inc. · 2013
- 2 generations backK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- 1 generation backK151322 Amendia Interbody Fusion DevicesAmendia, Inc. · 2015 · Recalled
- This deviceK162496 Foundation 3D InterbodyCorelink, LLC · 2017
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 82 · See all- K183064TxTi IBF SystemInnovasis, Inc. · 2019 · cites it directly48descendants
- K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc. · 2020 · 2 generations on47descendants
- K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc. · 2021 · 3 generations on38descendants
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 4 generations on36descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 4 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −15 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −14 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −13 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −10 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −9 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −6 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −5 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −4 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
| −3 | K123045 | Brigade Standalone System | Nuvasive, Inc. | 2013 | — |
| −2 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| −1 | K151322 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2015 | 1 |
| 0 (this device) | K162496 | Foundation 3D Interbody | Corelink, LLC | 2017 | — |
| +1 | K183064 | TxTi IBF System | Innovasis, Inc. | 2019 | 1 |
| +2 | K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | Innovasis, Inc. | 2020 | 1 |
| +3 | K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi… | Alphatec Spine, Inc. | 2021 | — |
| +4 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
| +4 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
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 | 10 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 11 | 0 |
| 2008 | 22 | 0 |
| 2009 | 11 | 0 |
| 2010 | 6 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 10 | 0 |
| 2023 | 13 | 0 |
| 2024 | 17 | 0 |
| 2025 | 15 | 0 |
| 2026 | 12 | 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? (3)
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 5…the predicate devices listed in Table 5-1 below. Table 5-1: Predicate Devices S10K Trade or Proprietary or Model Name Manufacturer Predicate Number Type K150847 M . i K073440 Foundation™ Interbody System CoreLink Primary K151322 | Interbody Fusion Device Amendia Additional K120486 | AVS AS System Strike… | 2008 |
| * | K151322 | Amendia Interbody Fusion DevicesSummary page 5…le 5-1: Predicate Devices S10K Trade or Proprietary or Model Name Manufacturer Predicate Number Type K150847 M . i K073440 Foundation™ Interbody System CoreLink Primary K151322 | Interbody Fusion Device Amendia Additional K120486 | AVS AS System Striker Spine | Additional K153250 Tesera SC Stand-alone Ant… | 2015 |
| * | K120486 | Avs as Peek SpacerSummary page 5…or Model Name Manufacturer Predicate Number Type K150847 M . i K073440 Foundation™ Interbody System CoreLink Primary K151322 | Interbody Fusion Device Amendia Additional K120486 | AVS AS System Striker Spine | Additional K153250 Tesera SC Stand-alone Anterior Cervical Fusion Renovis Reference (ACF) System… | 2012 |
| † | K153250 | Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System | 2016 |
| † | K150765 | LDR Spine ROI-C Cervical Cage System | 2015 |
| † | K121103 | LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal… | 2012 |
| † | K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants | 2011 |
| † | K112095 | Acculif TL-Peek Ibf Cage | 2011 |
| † | K123281 | Acculif TL-Peek Cage | 2013 |
| † | K123752 | Acculif TL and PL Cage | 2013 |
What descends from it? (82)
See all 8210 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183064 | TxTi IBF System | 2019 | 48 |
| K180814 | CoreLink® M3™ Stand-Alone Anterior Lumbar System | 2018 | 18 |
| K183239 | CoreLink F3D™ Lateral System | 2018 | 8 |
| K180556 | Corelink Foundation 3D Anterior Lumbar System | 2018 | 5 |
| K200458 | Tailored-C Cervical Interbody Fusion System | 2020 | 3 |
| K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | 2022 | 2 |
| K212075 | ShurFit Lumbar Interbody System | 2021 | 1 |
| K230329 | F3D Interbody System | 2023 | 0 |
| K230851 | Kodiak Lumbar Spacer System | 2023 | 0 |
| K201939 | GAIA Lumbar Interbody Fusion Device (LIFD) Family | 2020 | 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 33 years and passes through 13 companies; a new generation was cleared every 1.6 years on median.
- 20 of the 141 ancestors have a recall of any class.
- Of its descendants, K183064 (Innovasis, Inc., 2019) has gone furthest, with 48 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. 2017, 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 Foundation™ 3D Interbody Cervical Cage 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. 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…
Read the full statement (206 words)
The Foundation™ 3D Interbody Cervical Cage 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. 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.
The Foundation™ 3D Interbody Lumbar Cage 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 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 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/K162496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162496: Foundation 3D Interbody.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162496
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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