510(k) · Cleared
ClearedCosmoLock Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kalitec Direct, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 25, 2017 as substantially equivalent to K140678 (Kalitec Direct, LLC, 2014) and 4 other predicates after a 37-day review. Its family tree reaches back 9 generations to 1995. 2 later devices descend from it.
- Decided
- Oct 25, 2017
- Review
- 37 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K950697 (1995). 110 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 5 generations between
- 3 generations backK092631 Mantis Redux Spinal SystemStryker Spine · 2009
- 2 generations backK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
- 1 generation backK122845 ES2 Spinal System Model 48280XXXXStryker Spine · 2012
- This deviceK172808 CosmoLock Pedicle Screw SystemKalitec Direct, LLC · 2017
- Descendant · cites it directly · 0 of its ownK232572 Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical · 2023
- Descendant · cites it directly · 0 of its ownK230974 NIDO™ Pedicle Screw SystemKalitec Medical · 2023
Show all 9 generations
- Root · 9 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 8 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 7 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 6 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 5 generations backK061854 Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 4 generations backK063428 Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 3 generations backK092631 Mantis Redux Spinal SystemStryker Spine · 2009
- 2 generations backK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
- 1 generation backK122845 ES2 Spinal System Model 48280XXXXStryker Spine · 2012
- This deviceK172808 CosmoLock Pedicle Screw SystemKalitec Direct, LLC · 2017
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 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −8 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −7 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −6 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −5 | K061854 | Xia Titanium Spinal System and Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −4 | K063428 | Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −3 | K092631 | Mantis Redux Spinal System | Stryker Spine | 2009 | — |
| −2 | K102235 | Mantis Spinal System & Mantis Redux Spinal System | Stryker Spine | 2010 | — |
| −1 | K122845 | ES2 Spinal System Model 48280XXXX | Stryker Spine | 2012 | — |
| 0 (this device) | K172808 | CosmoLock Pedicle Screw System | Kalitec Direct, LLC | 2017 | — |
| +1 | K232572 | Kalitec Navigated Instrument System | Kalitec Direct, LLC Doing Business AS Kalitec Medical | 2023 | — |
| +1 | K230974 | NIDO™ Pedicle Screw System | Kalitec Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 12 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 9 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K140678 | Cosmolock Pedicle Screw SystemSummary page 4…on 888.3070 Device panel: Orthopedic Primary Legally Marketed Predicate CosmoLock Pedicle Screw System – Kalitec Direct (K140678) Device: Additional Synergy VLS – open (K940631 / K950099)… | 2014 |
| * | K940631 | Cross Medical - Synergy (TM) Spine SystemSummary page 4…Marketed Predicate CosmoLock Pedicle Screw System – Kalitec Direct (K140678) Device: Additional Synergy VLS – open (K940631 / K950099) Predicate Stryker ES2TM Spinal System (K122845) Devices: Depuy Viper… | 1995 |
| * | K950099 | Synergy (TM) TI Posterior Spinal SystemSummary page 4…keted Predicate CosmoLock Pedicle Screw System – Kalitec Direct (K140678) Device: Additional Synergy VLS – open (K940631 / K950099) Predicate Stryker ES2TM Spinal System (K122845) Devices: Depuy Viper Spine Syst… | 1997 |
| * | K122845 | ES2 Spinal System Model 48280XXXXSummary page 4…) Device: Additional Synergy VLS – open (K940631 / K950099) Predicate Stryker ES2TM Spinal System (K122845) Devices: Depuy Viper Spine System (K111136) Submitter: Kalitec Direct , LLC… | 2012 |
| * | K111136 | Expedium Spine System, Viper System, Viper 2 SystemSummary page 4…ynergy VLS – open (K940631 / K950099) Predicate Stryker ES2TM Spinal System (K122845) Devices: Depuy Viper Spine System (K111136) Submitter: Kalitec Direct , LLC 618 E. South Street, Suite 500… | 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 22 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 13 of the 110 ancestors have a recall of any class.
- Of its descendants, K232572 (Kalitec Direct, LLC Doing Business AS Kalitec Medical, 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K140678.
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 CosmoLock Pedicle Screw 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or…
Read the full statement (157 words)
The CosmoLock Pedicle Screw 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 spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.
The CosmoLock Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or 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/K172808 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172808: CosmoLock Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172808
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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