510(k) · Cleared
ClearedTiLock Modular 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 Nov 30, 2017 as substantially equivalent to K161914 (Genesys Spine, 2016) and 4 other predicates after a 107-day review. Its family tree reaches back 15 generations to 2004.
- Decided
- Nov 30, 2017
- Review
- 107 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K040583 (2004). 195 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations between
- 3 generations backK130646 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK133221 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · Recalled
- 1 generation backK142737 MAS PLIF Fixation systemNu Vasive, Incorporated · 2014
- This deviceK172469 TiLock Modular Spinal SystemGenesys Spine · 2017
Show all 15 generations
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 12 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 10 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 9 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 7 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 6 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 5 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 4 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 3 generations backK130646 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK133221 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · Recalled
- 1 generation backK142737 MAS PLIF Fixation systemNu Vasive, Incorporated · 2014
- This deviceK172469 TiLock Modular Spinal SystemGenesys Spine · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −12 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −10 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −9 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −7 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −6 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −5 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −4 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −3 | K130646 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −2 | K133221 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2014 | 2 |
| −1 | K142737 | MAS PLIF Fixation system | Nu Vasive, Incorporated | 2014 | — |
| 0 (this device) | K172469 | TiLock Modular Spinal System | Genesys Spine | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 3 | 0 |
| 1998 | 10 | 0 |
| 1999 | 5 | 0 |
| 2000 | 11 | 0 |
| 2001 | 11 | 0 |
| 2002 | 7 | 0 |
| 2003 | 12 | 0 |
| 2004 | 22 | 0 |
| 2005 | 19 | 0 |
| 2006 | 13 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 0 |
| 2009 | 13 | 0 |
| 2010 | 8 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K161914 | Genesys Spine TiLock Cortical Spinal SystemSummary page 4…ion Panel: Orthopedic Devices Panel Legally Marketed Primary Predicate: (unmodified) devices to TiLock2 Spinal System (Genesys Spine - K161914) Which Substantial Additional Predicate(s): Equivalence is Claimed: TiLock2 Spinal System (Genesys Spine… | 2016 |
| * | K171838 | TiLock2 Spinal SystemSummary page 4…Spinal System (Genesys Spine - K161914) Which Substantial Additional Predicate(s): Equivalence is Claimed: TiLock2 Spinal System (Genesys Spine - K171838) TiLock Pedicle Screw System (Genesys Spine - K100757 / K103671… | 2017 |
| * | K100757 | Tilock Pedicle Screw SystemSummary page 4…dicate(s): Equivalence is Claimed: TiLock2 Spinal System (Genesys Spine - K171838) TiLock Pedicle Screw System (Genesys Spine - K100757 / K103671) MAS PLIF Fixation System (NuVasive - K142737) DESCR… | 2010 |
| * | K103671 | Genesys Spine Tilock SystemSummary page 4…TiLock2 Spinal System (Genesys Spine - K171838) TiLock Pedicle Screw System (Genesys Spine - K100757 / K103671) MAS PLIF Fixation System (NuVasive - K142737) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET N… | 2011 |
| * | K142737 | MAS PLIF Fixation systemSummary page 4…TiLock Pedicle Screw System (Genesys Spine - K100757 / K103671) MAS PLIF Fixation System (NuVasive - K142737) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The Genesys Spine TiLock Modular Spinal System is a spinal system… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 6 companies; a new generation was cleared every 5 months on median.
- 23 of the 195 ancestors have a recall of any class.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Genesys Spine TiLock Modular Spinal System is intended for the following indications: The Genesys Spine TiLock Modular Spinal System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, 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 the posterior thoracic…
Read the full statement (282 words)
The Genesys Spine TiLock Modular Spinal System is intended for the following indications:
The Genesys Spine TiLock Modular Spinal System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, 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 the posterior thoracic, lumbar, and sacral spine: degenerative disc disease (DDD); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used for posterior non-cervical screw fixation in pediatric patients, Genesys Spine TiLock Modular Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Genesys Spine TiLock Modular Spinal 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.
The Genesys Spine TiLock Modular Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the Genesys Spine TiLock Modular Spinal System is also intended for the following indications: degenerative disc disease (DDD); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172469: TiLock Modular 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/K172469
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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