510(k) · Cleared
ClearedSEURAT™ Universal Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ctl Medical Corporation · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Feb 14, 2018 as substantially equivalent to K132365 (Accel Spine, 2013) and 3 other predicates after a 138-day review. Its family tree reaches back 12 generations to 1999.
- Decided
- Feb 14, 2018
- Review
- 138 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K990745 (1999). 145 ancestors in all, the oldest K884263 (1988). No later device cites it as a predicate yet.
- Root · 12 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 8 generations between
- 3 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 2 generations backK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK121568 Dali Spinal Fixation SystemAccel Spine · 2012
- This deviceK173185 SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation · 2018
Show all 12 generations
- Root · 12 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 11 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 10 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 9 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 8 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 7 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 6 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 5 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 4 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 3 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 2 generations backK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK121568 Dali Spinal Fixation SystemAccel Spine · 2012
- This deviceK173185 SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −11 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −10 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −9 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −8 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −7 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −6 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −5 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −4 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −3 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| −2 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| −1 | K121568 | Dali Spinal Fixation System | Accel Spine | 2012 | — |
| 0 (this device) | K173185 | SEURAT™ Universal Pedicle Screw System | Ctl Medical Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 14 | 0 |
| 2001 | 10 | 0 |
| 2002 | 5 | 0 |
| 2003 | 11 | 0 |
| 2004 | 10 | 0 |
| 2005 | 13 | 0 |
| 2006 | 11 | 0 |
| 2007 | 6 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (4)
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 |
|---|---|---|---|
| * | K132365 | Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationSummary page 5…Page 2 of 3 Predicate Devices Primary Predicate: K132365, Raphael Pedicle Screw System Additional Predicates:… | 2013 |
| * | K120714 | Picasso Mis Spinal Fixation SystemSummary page 5…K132365, Raphael Pedicle Screw System Additional Predicates: K120714, PICASSO MIS Spinal System K121568, DALI Spinal Fixation System… | 2012 |
| * | K121568 | Dali Spinal Fixation SystemSummary page 5…Additional Predicates: K120714, PICASSO MIS Spinal System K121568, DALI Spinal Fixation System K140219, PICASSO II MIS Spinal System Device Description I… | 2012 |
| * | K140219 | Picasso II Mis Spinal SystemSummary page 5…K120714, PICASSO MIS Spinal System K121568, DALI Spinal Fixation System K140219, PICASSO II MIS Spinal System Device Description Indications for Use: The SEURAT™ Universal Pedicle Screw System is intended… | 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 19 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 15 of the 145 ancestors have a recall of any class.
- 1 other device also cites its predicate K132365.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 SEURAT™ Universal Pedicle Screw System is intended to provide immobilization and stabilization of the spinal segments, (T1 – S2/ilium) or as an anterolateral fixation system (T8 – L5), in skeletally mature patients as an adjunct to fusion. The SEURAT™ Universal Pedicle Screw System is a posterior, non-cervical, pedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by…
Read the full statement (112 words)
The SEURAT™ Universal Pedicle Screw System is intended to provide immobilization and stabilization of the spinal segments, (T1 – S2/ilium) or as an anterolateral fixation system (T8 – L5), in skeletally mature patients as an adjunct to fusion. The SEURAT™ Universal Pedicle Screw System is a posterior, non-cervical, pedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor, pseudarthosis; and failed previous fusion.
The SEURAT™ Universal Pedicle Screw System can be used in an open approach and percutaneous approach with MIS instrumentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173185: SEURAT™ Universal 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/K173185
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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