510(k) Report

510(k) · Cleared

Cleared

Foundation Cage

K073440510(k) TraditionalCleared Apr 24, 2008139-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Corelink, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Apr 24, 2008 as substantially equivalent to P980048 (Sulzer Spine-Tech, 2001) and 1 other predicate after a 139-day review. Its family tree reaches back 1 generation to 1999. 126 later devices descend from it.

Decided
Apr 24, 2008
Review
139 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to P960025 (1999). 2 ancestors in all. 126 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2015: 1 descendant cleared2013: 2 descendants cleared2017: 9 descendants cleared2014: 2 descendants cleared2018: 6 descendants cleared2016: 1 descendant cleared2023: 17 descendants cleared2021: 7 descendants cleared2020: 8 descendants cleared2022: 15 descendants cleared2019: 4 descendants cleared2025: 17 descendants cleared2024: 22 descendants cleared2026: 15 descendants clearedP960025 · Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws · Depuy Spine, Inc. · 19991995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 18 descendants3 generations forward: 28 descendants4 generations forward: 25 descendants5 generations forward: 24 descendants6 generations forward: 17 descendants7 generations forward: 9 descendants P960025 · Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws · Depuy Spine, Inc. · 19990+5
  1. Root · 1 generation backP960025 Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle…Depuy Spine, Inc. · 1999
  2. This deviceK073440 Foundation CageCorelink, LLC · 2008
  3. Descendant · cites it directly · 82 of its ownK162496 Foundation 3D InterbodyCorelink, LLC · 2017
  4. Descendant · 2 generations on · 48 of its ownK183064 TxTi IBF SystemInnovasis, Inc. · 2019 · Recalled
  5. Descendant · 3 generations on · 47 of its ownK201614 TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc. · 2020 · Recalled
  6. Descendant · cites it directly · 40 of its ownK121254 Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies · 2013
  7. Descendant · 4 generations on · 38 of its ownK211805 IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody…Alphatec Spine, Inc. · 2021

Showing 5 of 126 descendants. See all descendants

Descendants cleared per year

2013: 22014: 22015: 12016: 12017: 92018: 62019: 42020: 82021: 72022: 152023: 172024: 222025: 172026: 15
2013high 22 (2024) · low 1 (2015)2026

Most influential descendants

Showing 5 of 126 · See all
  • K162496Foundation 3D InterbodyCorelink, LLC · 2017 · cites it directly82descendants
  • K183064TxTi IBF SystemInnovasis, Inc. · 2019 · 2 generations on48descendants
  • K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc. · 2020 · 3 generations on47descendants
  • K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies · 2013 · cites it directly40descendants
  • K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc. · 2021 · 4 generations on38descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsDepuy Spine, Inc.1999—
0 (this device)K073440Foundation CageCorelink, LLC2008—
+1K162496Foundation 3D InterbodyCorelink, LLC2017—
+2K183064TxTi IBF SystemInnovasis, Inc.20191
+3K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20201
+1K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies2013—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi…Alphatec Spine, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201420
201510
201610
201790
201860
201940
202080
202170
2022150
2023170
2024220
2025170
2026150
FIG. 1 — Lineage of K073440, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*P980048Bak/Cervical (Bak/C) Interbody Fusion System
Summary page 1
…ODP MAX 3. Predicate or legally marketed devices which are substantially equivalent: BAK/C Vista Interbody Fusion (P980048 S003) BRANTIGEN I/F CAGE (P960025) 4. Description of the device: The interbody fusion with autogenous bone graft so…
Sulzer Spine-Tech2001—
*P960025Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws
Summary page 1
…MAX 3. Predicate or legally marketed devices which are substantially equivalent: BAK/C Vista Interbody Fusion (P980048 S003) BRANTIGEN I/F CAGE (P960025) 4. Description of the device: The interbody fusion with autogenous bone graft solves and provides a logical solution for…
Depuy Spine, Inc.1999—

Also cleared against P980048: 53 other devices →

What descends from it? (126)

See all 126

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162496Foundation 3D InterbodyCorelink, LLC201782
K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340
K150847Foundation Interbody DevicesCorelink, LLC201529
K133529Camber Spine Coveris Cervical CageCamber Spine201410
K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K162496 (Corelink, LLC, 2017) has gone furthest, with 82 descendants of its own.
  • 53 other devices also cite its predicate P980048.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

Foundation TM 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 (225 words)

Foundation TM 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 the C3 to C7 disc levels 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 TM 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 TM Lumbar implants are to be used with autogenous bone graft and implanted via an open anterior or posterior approach. Foundation TM Lumbar implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Indications for use as stated in the FDA summary.

Also cleared against P980048

53 other devices cite the same predicate.

  • K253260ORIO-3D Cage SystemSpineCraft · 2026
  • K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC · 2021
  • K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
  • K182477Cervical SpacerAdditive Implants, LLC · 2019
  • K181471ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC · 2018
  • K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018

More from Corelink, LLC

35 FDA decisions under this applicant name. See the company

  • K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate SystemCorelink, LLC · 2023
  • K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC · 2023
  • K232116CoreLink Navigation InstrumentsCorelink, LLC · 2023
  • K230329F3D Interbody SystemCorelink, LLC · 2023
  • K230880CoreLink Navigation InstrumentsCorelink, LLC · 2023

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K073440 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073440: Foundation Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073440

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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