510(k) · Cleared
ClearedCuriteva Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curiteva, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Aug 28, 2019 as substantially equivalent to K162367 (Clariance, Sas, 2016) after a 54-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Aug 28, 2019
- Review
- 54 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K950697 (1995). 65 ancestors in all, the oldest K944736 (1995). No later device cites it as a predicate yet.
- Root · 10 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 6 generations between
- 3 generations backK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
- 2 generations backK122845 ES2 Spinal System Model 48280XXXXStryker Spine · 2012
- 1 generation backK162367 Erisma® LP MISClariance, Sas · 2016
- This deviceK191810 Curiteva Pedicle Screw SystemCuriteva, Inc. · 2019
Show all 10 generations
- Root · 10 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 9 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 8 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 7 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 6 generations backK061854 Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 5 generations backK063428 Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 4 generations backK092631 Mantis Redux Spinal SystemStryker Spine · 2009
- 3 generations backK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
- 2 generations backK122845 ES2 Spinal System Model 48280XXXXStryker Spine · 2012
- 1 generation backK162367 Erisma® LP MISClariance, Sas · 2016
- This deviceK191810 Curiteva Pedicle Screw SystemCuriteva, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −9 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −8 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −7 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −6 | K061854 | Xia Titanium Spinal System and Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −5 | K063428 | Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −4 | K092631 | Mantis Redux Spinal System | Stryker Spine | 2009 | — |
| −3 | K102235 | Mantis Spinal System & Mantis Redux Spinal System | Stryker Spine | 2010 | — |
| −2 | K122845 | ES2 Spinal System Model 48280XXXX | Stryker Spine | 2012 | — |
| −1 | K162367 | Erisma® LP MIS | Clariance, Sas | 2016 | — |
| 0 (this device) | K191810 | Curiteva Pedicle Screw System | Curiteva, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K150896 | FDA’s K150896 is Vitality Spinal Fixation System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2015 |
| * | K162367 | Erisma® LP MISSummary page 4…opedic Devices Predicate Device(s): Zimmer Spine Vitality Spinal Fixation System – <ϭϱϬϴϵϲ ĚĚŝƚŝŽŶĂůƉƌĞĚŝĐĂƚĞ͗ Clariance Spine Erisma LP MIS – K162367 C. Device Description The Curiteva Pedicle Screw System is a thoracolumbar and/or sacral spine fixation system for spinal surgery… | 2016 |
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 24 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 65 ancestors have a recall of any class.
- 1 other device also cites its predicate K162367.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Curiteva Pedicle Screw System is intended for posterior, non-cervical pedicle screw fixation (T1-S2/ilium) and hook fixation (T1-L5) in skeletally mature patients as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudarthrosis and/or failed previous fusion. The Curiteva Pedicle Screw System is intended to be used with autograft and/or allograft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191810: Curiteva Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191810
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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