510(k) · Cleared
ClearedCorticaLINK Spinal Fusion Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Facetlink Dba Linkspine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 7, 2016 as substantially equivalent to K000236 (Interpore Cross Intl., 2000) and 2 other predicates after a 113-day review. Its family tree reaches back 9 generations to 1985. 2 later devices descend from it.
- Decided
- Jul 7, 2016
- Review
- 113 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K853033 (1985). 47 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 5 generations between
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK050979 S4 Spinal SystemAesculap, Inc. · 2005
- This deviceK160722 CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine · 2016
- Descendant · cites it directly · 0 of its ownK193465 CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC · 2020
- Descendant · cites it directly · 0 of its ownK173484 CorticaLINK Spinal Fusion PlatformLinkspine, Inc. · 2017
Show all 9 generations
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 7 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 6 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 5 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 4 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK050979 S4 Spinal SystemAesculap, Inc. · 2005
- This deviceK160722 CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −8 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −7 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −6 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −5 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −4 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −3 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −2 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K050979 | S4 Spinal System | Aesculap, Inc. | 2005 | — |
| 0 (this device) | K160722 | CorticaLINK Spinal Fusion Platform | Facetlink Dba Linkspine | 2016 | — |
| +1 | K193465 | CorticaLINK Spinal Fusion Platform | Spine Smith Holdings, LLC | 2020 | — |
| +1 | K173484 | CorticaLINK Spinal Fusion Platform | Linkspine, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 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 NKB? 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? (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 |
|---|---|---|---|
| * | K000236 | Synergy VLS Cap Nut Models 2206, 6102Summary page 6…icate 510k Number Trade or Proprietary or Model Name Manufacturer Type K000236 Synergy VLS Open Interpore Primary K050979 S4 Spinal System… | 2000 |
| * | K050979 | S4 Spinal SystemSummary page 6…Type K000236 Synergy VLS Open Interpore Primary K050979 S4 Spinal System Aesculap®, Inc. Additional K111940 S 100 Pedicle Screw Syste… | 2005 |
| * | K111940 | S 100 Pedicle Screw SystemSummary page 6…Synergy VLS Open Interpore Primary K050979 S4 Spinal System Aesculap®, Inc. Additional K111940 S 100 Pedicle Screw System Renovis Additional PERFORMANCE DATA The CorticaLINK Spinal Fusio… | 2012 |
What descends from it? (2)
2 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 31 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 47 ancestors have a recall of any class.
- Of its descendants, K193465 (Spine Smith Holdings, LLC, 2020) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K000236.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 CorticaLINK Spinal Fusion Platform is intended for non-cervical pedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients:
x degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
x spondylolisthesis;
x trauma (i.e., fracture or dislocation);
x spinal stenosis;
x curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
x tumor;
x pseudoarthrosis;
and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160722 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160722: CorticaLINK Spinal Fusion Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160722
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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