510(k) · Cleared
ClearedGenesys Spine TiLock Cortical Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesys Spine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Aug 9, 2016 as substantially equivalent to K100757 (Genesys Spine, 2010) and 2 other predicates after a 28-day review. Its family tree reaches back 11 generations to 1999. 1 later device descends from it.
- Decided
- Aug 9, 2016
- Review
- 28 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K990745 (1999). 67 ancestors in all, the oldest K884263 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations between
- 3 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 2 generations backK103671 Genesys Spine Tilock SystemGenesys Spine · 2011
- 1 generation backK152039 Genesys Spine TiLock2 Spinal SystemGenesys Spine · 2015
- This deviceK161914 Genesys Spine TiLock Cortical Spinal SystemGenesys Spine · 2016
- Descendant · cites it directly · 0 of its ownK172469 TiLock Modular Spinal SystemGenesys Spine · 2017
Show all 11 generations
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 10 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 9 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 8 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 7 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 6 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 5 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 4 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 3 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 2 generations backK103671 Genesys Spine Tilock SystemGenesys Spine · 2011
- 1 generation backK152039 Genesys Spine TiLock2 Spinal SystemGenesys Spine · 2015
- This deviceK161914 Genesys Spine TiLock Cortical Spinal SystemGenesys Spine · 2016
Most influential descendants
Showing 1 of 1 · See all- K172469TiLock Modular Spinal SystemGenesys Spine · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −10 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −9 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −8 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −7 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −6 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −5 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −4 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −3 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −2 | K103671 | Genesys Spine Tilock System | Genesys Spine | 2011 | — |
| −1 | K152039 | Genesys Spine TiLock2 Spinal System | Genesys Spine | 2015 | — |
| 0 (this device) | K161914 | Genesys Spine TiLock Cortical Spinal System | Genesys Spine | 2016 | — |
| +1 | K172469 | TiLock Modular Spinal System | Genesys Spine | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K100757 | Tilock Pedicle Screw SystemSummary page 4…Legally Marketed Primary Predicate: (unmodified) devices to TiLock Pedicle Screw System (Genesys Spine - Which Substantial K100757) Equivalence is Claimed: Additional Predicate(s): TiLock2 Spinal System (Genesys… | 2010 |
| * | K103671 | Genesys Spine Tilock SystemSummary page 4…bstantial K100757) Equivalence is Claimed: Additional Predicate(s): TiLock2 Spinal System (Genesys Spine - K103671 / K152039) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The intent of this S… | 2011 |
| * | K152039 | Genesys Spine TiLock2 Spinal SystemSummary page 4…ce is Claimed: Additional Predicate(s): TiLock2 Spinal System (Genesys Spine - K103671 / K152039) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The intent of this Special 510(k) is to add new components to the… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172469 | TiLock Modular Spinal System | 2017 | 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 17 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 67 ancestors have a recall of any class.
- Of its descendants, K172469 (Genesys Spine, 2017) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K100757.
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 TiLock Cortical Spinal 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 spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.c., fracture or dislocation); spinal stenosis; curvatures (i.c., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
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/K161914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161914: Genesys Spine TiLock Cortical Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161914
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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