510(k) · Cleared
ClearedCoreLink Midline Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corelink, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 15, 2021 as substantially equivalent to K131250 (Corelink, LLC, 2013) and 8 other predicates after a 50-day review. Its family tree reaches back 20 generations to 2001. 1 of the 583 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Apr 15, 2021
- Review
- 50 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 20 generations to K003155 (2001). 578 ancestors in all, the oldest K781443 (1978). 4 later devices descend from it, 3 citing it directly. 1 of the 583 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 16 generations between
- 3 generations backK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
- 2 generations backK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- 1 generation backK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
- This deviceK210539 CoreLink Midline Fixation SystemCorelink, LLC · 2021
- Descendant · cites it directly · 2 of its ownK221776 NextGen Pedicle Screw SystemCorelink, LLC · 2022
- Descendant · cites it directly · 0 of its ownK260989 Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI) · 2026
- Descendant · cites it directly · 0 of its ownK231494 CoreLink Robotic Navigation InstrumentsCorelink, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK230880 CoreLink Navigation InstrumentsCorelink, LLC · 2023
Show all 20 generations
- Root · 20 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 19 generations backK012254 VBROsteotech, Inc. · 2001
- 18 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 17 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 16 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 15 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 10 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 8 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 7 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 6 generations backK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- 5 generations backK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- 4 generations backK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- 3 generations backK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
- 2 generations backK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
- 1 generation backK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017
- This deviceK210539 CoreLink Midline Fixation SystemCorelink, LLC · 2021
Class I recalls in this family
- K100952 Modification to Synthes Matrix Systemdirect predicate · 2010
Most influential descendants
Showing 4 of 4 · See all- K221776NextGen Pedicle Screw SystemCorelink, LLC · 2022 · cites it directly2descendants
- K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI) · 2026 · cites it directly0descendants
- K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC · 2023 · cites it directly0descendants
- K230880CoreLink Navigation InstrumentsCorelink, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −19 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −18 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −17 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −16 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −15 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −10 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −8 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −7 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −6 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| −5 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| −4 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| −3 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | — |
| −2 | K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | — |
| −1 | K173130 | Reform® Midline Cortical Screw System | Precision Spine, Inc. | 2017 | — |
| 0 (this device) | K210539 | CoreLink Midline Fixation System | Corelink, LLC | 2021 | — |
| +1 | K221776 | NextGen Pedicle Screw System | Corelink, LLC | 2022 | — |
| +1 | K260989 | Varion Thoracolumbar Fixation System | Kyocera Medical Technologies Inc. (KMTI) | 2026 | — |
| +1 | K231494 | CoreLink Robotic Navigation Instruments | Corelink, LLC | 2023 | — |
| +2 | K230880 | CoreLink Navigation Instruments | Corelink, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 17 | 0 |
| 1996 | 13 | 0 |
| 1997 | 15 | 0 |
| 1998 | 23 | 0 |
| 1999 | 21 | 0 |
| 2000 | 33 | 0 |
| 2001 | 38 | 0 |
| 2002 | 32 | 0 |
| 2003 | 30 | 0 |
| 2004 | 50 | 0 |
| 2005 | 41 | 0 |
| 2006 | 31 | 0 |
| 2007 | 21 | 0 |
| 2008 | 32 | 0 |
| 2009 | 26 | 0 |
| 2010 | 27 | 1 |
| 2011 | 23 | 0 |
| 2012 | 16 | 0 |
| 2013 | 12 | 0 |
| 2014 | 7 | 0 |
| 2015 | 6 | 0 |
| 2016 | 6 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 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.
1 device in this family has a Class I recall. 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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 |
|---|---|---|---|
| * | K131250 | Tiger Spine SystemSummary page 5…rade or Proprietary or Model Name Manufacturer Predicate Number Type K131250, Tiger Spine System CoreLink, LLC Primary K120696, K1(10321 K190360 LineSid… | 2013 |
| * | K120696 | Tiger Spine SystemSummary page 5…Type K131250, Tiger Spine System CoreLink, LLC Primary K120696, K1(10321 K190360 LineSider TM Spinal Screw Integrity Implants, Inc Additional Kl80179 JANU… | 2012 |
| * | K110321 | Tiger Spine System | 2011 |
| * | K190360 | LineSider™ Spinal SystemSummary page 5…Type K131250, Tiger Spine System CoreLink, LLC Primary K120696, K1(10321 K190360 LineSider TM Spinal Screw Integrity Implants, Inc Additional Kl80179 JANUS Midline Fixation S… | 2019 |
| * | K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®… | 2018 |
| * | K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Summary page 5…r TM Spinal Screw Integrity Implants, Inc Additional Kl80179 JANUS Midline Fixation System Orthofix Inc. Additional K171082 K173130 Reform® Midline Cortical Screw System Precision Spine, Inc. Additional K100952 Synthes Matrix… | 2017 |
| * | K173130 | Reform® Midline Cortical Screw SystemSummary page 5…al Screw Integrity Implants, Inc Additional Kl80179 JANUS Midline Fixation System Orthofix Inc. Additional K171082 K173130 Reform® Midline Cortical Screw System Precision Spine, Inc. Additional K100952 Synthes Matrix System… | 2017 |
| * | K100952 | Modification to Synthes Matrix SystemSummary page 5…ation System Orthofix Inc. Additional K171082 K173130 Reform® Midline Cortical Screw System Precision Spine, Inc. Additional K100952 Synthes Matrix System Synthes Spine Additional K181390 Response Spine System… | 2010 |
| * | K181390 | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemSummary page 5…Midline Cortical Screw System Precision Spine, Inc. Additional K100952 Synthes Matrix System Synthes Spine Additional K181390 Response Spine System OrthoPediatrics, Corp. Additional K163104 TerraceTM Anterior Cervi… | 2018 |
| † | K163104 | Terrace™ Anterior Cervical Plate System | 2017 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 68 of the 578 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K221776 (Corelink, LLC, 2022) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K131250.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The CoreLink Midline Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 - Si/llium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative…
Read the full statement (154 words)
The CoreLink Midline Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 - Si/llium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used for posterior non-cervical screw fixation in pediatric patients, the CoreLink Midline Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CoreLink Midline Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210539 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210539: CoreLink Midline Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210539
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