510(k) · Cleared
ClearedKentrospine Viktr-MIS® Pedicle screw system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rivarp Medical Pvt., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 27, 2026 as substantially equivalent to K183117 (L&K BIOMED Co., Ltd., 2018) after a 446-day review. Its family tree reaches back 11 generations to 1995.
- Decided
- Sep 27, 2026
- Review
- 446 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K950697 (1995). 66 ancestors in all, the oldest K933881 (1994). No later device cites it as a predicate yet.
- Root · 11 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 7 generations between
- 3 generations backK120140 Focus Spinal SystemL&K BIOMED Co., Ltd. · 2012
- 2 generations backK161766 PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd. · 2016
- 1 generation backK183117 PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd. · 2018
- This deviceK252139 Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026
Show all 11 generations
- Root · 11 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 10 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 9 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 8 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 7 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 6 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- 5 generations backK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
- 4 generations backK112643 Focus Mis SystemL&K BIOMED Co., Ltd. · 2012
- 3 generations backK120140 Focus Spinal SystemL&K BIOMED Co., Ltd. · 2012
- 2 generations backK161766 PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd. · 2016
- 1 generation backK183117 PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd. · 2018
- This deviceK252139 Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −10 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −9 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −8 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −7 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −6 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −5 | K090648 | Viper 2 System | Depuy Spine, Inc. | 2009 | — |
| −4 | K112643 | Focus Mis System | L&K BIOMED Co., Ltd. | 2012 | — |
| −3 | K120140 | Focus Spinal System | L&K BIOMED Co., Ltd. | 2012 | — |
| −2 | K161766 | PathLoc-L MIS Spinal System | L&K BIOMED Co., Ltd. | 2016 | — |
| −1 | K183117 | PathLoc-L MIS Spinal System | L&K BIOMED Co., Ltd. | 2018 | — |
| 0 (this device) | K252139 | Kentrospine Viktr-MIS® Pedicle screw system | Rivarp Medical Pvt., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (1)
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 |
|---|---|---|---|
| * | K183117 | PathLoc-L MIS Spinal SystemSummary page 5…888.3070 Product Code(s) NKB | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K183117 PathLoc-L MIS Spinal System NKB Device Description Summary 21 CFR 807.92(a)(4) The Kentrospine Viktr-MIS® Pedicle screw system i… | 2018 |
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 31 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 66 ancestors have a recall of any class.
- 2 other devices also cite its predicate K183117.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Kentrospine Viktr-MIS® 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 acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The Kentrospine Viktr-MIS® Pedicle screw system is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for rigid fixation…
Read the full statement (136 words)
The Kentrospine Viktr-MIS® 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 acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The Kentrospine Viktr-MIS® Pedicle screw system is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for rigid fixation and stability with following indications: 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; Pseudarthrosis; and/or failed previous fusion.
The Kentrospine Viktr-MIS® Pedicle screw system can be used in an open approach and a percutaneous approach with Kentrospine Viktr-MIS® Pedicle screw system instruments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252139: Kentrospine Viktr-MIS® 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/K252139
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026