510(k) · Cleared
ClearedCoreLink® M3™ Stand-Alone Anterior Lumbar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corelink, LLC · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Aug 10, 2018 as substantially equivalent to K151214 (Nu Vasive, Incorporated, 2015) and 4 other predicates after a 134-day review. Its family tree reaches back 17 generations to 1984. 18 later devices descend from it.
- Decided
- Aug 10, 2018
- Review
- 134 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K841189 (1984). 201 ancestors in all. 18 later devices descend from it, 6 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 2 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 1 generation backK151214 ALIF Interfixated SystemNu Vasive, Incorporated · 2015
- This deviceK180814 CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC · 2018
- Descendant · cites it directly · 10 of its ownK192492 EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC · 2020
- Descendant · 2 generations on · 5 of its ownK222554 EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023
- Descendant · 2 generations on · 3 of its ownK214047 EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical · 2022
- Descendant · 3 generations on · 2 of its ownK240126 ProAM ALIF SystemPro Surgical, Inc. · 2024
- Descendant · 3 generations on · 2 of its ownK230731 Zavation ALIF SystemZavation Medical Products, LLC · 2023
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 backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 4 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 3 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 2 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 1 generation backK151214 ALIF Interfixated SystemNu Vasive, Incorporated · 2015
- This deviceK180814 CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC · 2018
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC · 2020 · cites it directly10descendants
- K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023 · 2 generations on5descendants
- K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical · 2022 · 2 generations on3descendants
- K240126ProAM ALIF SystemPro Surgical, Inc. · 2024 · 3 generations on2descendants
- K230731Zavation ALIF SystemZavation Medical Products, LLC · 2023 · 3 generations on2descendants
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 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −4 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −3 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −2 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −1 | K151214 | ALIF Interfixated System | Nu Vasive, Incorporated | 2015 | — |
| 0 (this device) | K180814 | CoreLink® M3™ Stand-Alone Anterior Lumbar System | Corelink, LLC | 2018 | — |
| +1 | K192492 | EL CAPITAN Anterior Lumber Interbody System | Astura Medical, LLC | 2020 | — |
| +2 | K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | Astura Medical | 2023 | — |
| +2 | K214047 | EL CAPITAN Anterior Lumbar Interbody Fusion System | Astura Medical | 2022 | — |
| +3 | K240126 | ProAM ALIF System | Pro Surgical, Inc. | 2024 | — |
| +3 | K230731 | Zavation ALIF System | Zavation Medical Products, LLC | 2023 | — |
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 | 14 | 0 |
| 2004 | 16 | 0 |
| 2005 | 17 | 0 |
| 2006 | 4 | 0 |
| 2007 | 13 | 0 |
| 2008 | 30 | 0 |
| 2009 | 16 | 0 |
| 2010 | 13 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 12 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K151214 | ALIF Interfixated SystemSummary page 5…Use e Materials of manufacture e Structural support mechanism Table 5-1 Predicate Devices 510k Number Trade or Proprietary or Model Manufacturer | Predicate Name Type K151214 ALIF Interfixated System NuVasive Primary K111626 Endoskeleton TAS Titan Spine Additional K142095 Tesera SA ALIF Interbody System… | 2015 |
| * | K111626 | Endoskeleton (R) TasSummary page 5…rt mechanism Table 5-1 Predicate Devices 510k Number Trade or Proprietary or Model Manufacturer | Predicate Name Type K151214 ALIF Interfixated System NuVasive Primary K111626 Endoskeleton TAS Titan Spine Additional K142095 Tesera SA ALIF Interbody System | Renovis Spine | Additional K150847 CoreLink Lat… | 2011 |
| * | K142095 | Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemSummary page 5…Number Trade or Proprietary or Model Manufacturer | Predicate Name Type K151214 ALIF Interfixated System NuVasive Primary K111626 Endoskeleton TAS Titan Spine Additional K142095 Tesera SA ALIF Interbody System | Renovis Spine | Additional K150847 CoreLink Lateral CoreLink Additional K162496 Foundation™ 3D… | 2014 |
| * | K150847 | Foundation Interbody DevicesSummary page 5…pe K151214 ALIF Interfixated System NuVasive Primary K111626 Endoskeleton TAS Titan Spine Additional K142095 Tesera SA ALIF Interbody System | Renovis Spine | Additional K150847 CoreLink Lateral CoreLink Additional K162496 Foundation™ 3D Interbody CoreLink Additional PERFORMANCE DATA The M3 Stand-Alone An… | 2015 |
| * | K162496 | Foundation 3D InterbodySummary page 5…Primary K111626 Endoskeleton TAS Titan Spine Additional K142095 Tesera SA ALIF Interbody System | Renovis Spine | Additional K150847 CoreLink Lateral CoreLink Additional K162496 Foundation™ 3D Interbody CoreLink Additional PERFORMANCE DATA The M3 Stand-Alone Anterior Lumbar System has been tested in the f… | 2017 |
What descends from it? (18)
See all 186 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192492 | EL CAPITAN Anterior Lumber Interbody System | 2020 | 10 |
| K211769 | OneLIF Intervertebral Body Replacement System | 2021 | 1 |
| K200541 | Hive™ Stand-alone Anterior Lumbar Interbody System | 2020 | 1 |
| K234077 | SPIRA® Anterior Lumbar Spacers | 2024 | 0 |
| K230329 | F3D Interbody System | 2023 | 0 |
| K202190 | Oculus-SA Lumbar Cage System | 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 34 years and passes through 15 companies; a new generation was cleared every 1.0 years on median.
- 28 of the 201 ancestors have a recall of any class.
- Of its descendants, K192492 (Astura Medical, LLC, 2020) has gone furthest, with 10 descendants of its own.
- 6 other devices also cite its predicate K151214.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The CoreLink® M3™ Stand-Alone Anterior Lumbar System is a standalone interbody fusion system indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The…
Read the full statement (200 words)
The CoreLink® M3™ Stand-Alone Anterior Lumbar System is a standalone interbody fusion system indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The device may be used with supplemental fixation.
Hyperlordotic implants (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation) that are cleared by the FDA for use in the lumbar spine. The system is indicated to be used with autograft bone. Patients should have received 6 months of non- operative treatment prior to treatment with the devices.
The implants are intended to be used with the bone screws and lock provided. The system is designed to be a 3-screw implant, and all three (3) screws must be used. The accompanying lock must be used anytime the device is used with any number of screws. If the physician chooses to use less than the recommended number, then additional supplemental fixation in the lumbar spine must be used to augment fixation.
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/K180814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180814: CoreLink® M3™ Stand-Alone 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/K180814
Report an extraction error
Are you the manufacturer?
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