510(k) · Cleared
ClearedViking Lumbar Polyaxial Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Presidio Surgical · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 13, 2018 as substantially equivalent to K120091 (R&D Innovation, LLC, 2012) and 2 other predicates after a 122-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Jul 13, 2018
- Review
- 122 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K950697 (1995). 32 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 7 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 6 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 5 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 4 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 3 generations backK071373 Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · Recalled
- 2 generations backK083393 Xia 3 Spinal SystemStryker Spine · 2009 · Recalled
- 1 generation backK111940 S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC · 2012
- This deviceK180655 Viking Lumbar Polyaxial Screw SystemPresidio Surgical · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −7 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −6 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −5 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −4 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −3 | K071373 | Stryker Spine Xia Iii Spinal System | Stryker Spine | 2007 | 1 |
| −2 | K083393 | Xia 3 Spinal System | Stryker Spine | 2009 | 1 |
| −1 | K111940 | S 100 Pedicle Screw System | Renovis Surgical Technologies, LLC | 2012 | — |
| 0 (this device) | K180655 | Viking Lumbar Polyaxial Screw System | Presidio Surgical | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K120091 | R&D Innovation Pedicle Screw SystemSummary page 5…5-1: Predicate Devices 510k Trade or Proprietary or Manufacturer Predicate Number Model Name K120091 Pedicle Screw System R&D Innovation Primary Fortex Pedicle Screw K120832… | 2012 |
| * | K120832 | Fortex Pedicle Screw SystemSummary page 5…rer Predicate Number Model Name K120091 Pedicle Screw System R&D Innovation Primary Fortex Pedicle Screw K120832 X-Spine Additional System K111940 S 100 Pedicle Screw… | 2012 |
| * | K111940 | S 100 Pedicle Screw SystemSummary page 5…novation Primary Fortex Pedicle Screw K120832 X-Spine Additional System K111940 S 100 Pedicle Screw System Renovis Additional PERFORMANCE TESTING SUMMARY In support of this Tradit… | 2012 |
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 23 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 7 of the 32 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. 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?
When used as a pedicle screw fixation system in the non-cervical posterior spine (T1-S1) in skeletally mature patients, the Presidio Surgical Viking 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 the thoracic, lumbar and sacral spine: (1) degenerative disc disease…
Read the full statement (125 words)
When used as a pedicle screw fixation system in the non-cervical posterior spine (T1-S1) in skeletally mature patients, the Presidio Surgical Viking 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 the thoracic, lumbar and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (7) tumor, (8) failed previous fusion (i.e. pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180655 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180655: Viking Lumbar Polyaxial Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180655
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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