510(k) · Cleared
ClearedFOCUS Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nvision Biomedical Technologies, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 17, 2018 as substantially equivalent to K161363 (Alphatec Spine, Inc., 2016) and 1 other predicate after a 56-day review. Its family tree reaches back 17 generations to 2004. 1 later device descends from it.
- Decided
- Apr 17, 2018
- Review
- 56 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K040583 (2004). 182 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations between
- 3 generations backK143149 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
- 2 generations backK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
- 1 generation backK161363 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016
- This deviceK180458 FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC · 2018
- Descendant · cites it directly · 0 of its ownK200937 ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd. · 2020
Show all 17 generations
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 5 generations backK130646 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 4 generations backK133221 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · Recalled
- 3 generations backK143149 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
- 2 generations backK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
- 1 generation backK161363 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016
- This deviceK180458 FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC · 2018
Most influential descendants
Showing 1 of 1 · See all- K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −14 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −12 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −9 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −8 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −7 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −6 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −5 | K130646 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −4 | K133221 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2014 | 2 |
| −3 | K143149 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2015 | — |
| −2 | K152968 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2015 | — |
| −1 | K161363 | Arsenal Spinal Fixation System | Alphatec Spine, Inc. | 2016 | — |
| 0 (this device) | K180458 | FOCUS Pedicle Screw System | Nvision Biomedical Technologies, LLC | 2018 | — |
| +1 | K200937 | ACURA Stabilization System | Indius Medical Technologies Pvt., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 6 | 0 |
| 1997 | 3 | 0 |
| 1998 | 11 | 0 |
| 1999 | 3 | 0 |
| 2000 | 15 | 0 |
| 2001 | 15 | 0 |
| 2002 | 10 | 0 |
| 2003 | 13 | 0 |
| 2004 | 18 | 0 |
| 2005 | 12 | 0 |
| 2006 | 7 | 0 |
| 2007 | 7 | 0 |
| 2008 | 9 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K161363 | Arsenal Spinal Fixation SystemSummary page 5…icle Screw System is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K161363 Arsenal Spinal Fixation System / Alphatec Spine, Inc. 9 K101278 Inertia Pedicle Screw System /… | 2016 |
| * | K101278 | Inertia Pedicle Screw SystemSummary page 5…r Predicate Device Name / Manufacturer Primary Predicate K161363 Arsenal Spinal Fixation System / Alphatec Spine, Inc. 9 K101278 Inertia Pedicle Screw System / Nexxt Spine LLC SUMMARY OF NON-CLINICAL TESTING No FDA performance standards have been… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200937 | ACURA Stabilization System | 2020 | 0 |
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 14 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 21 of the 182 ancestors have a recall of any class.
- Of its descendants, K200937 (Indius Medical Technologies Pvt., Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K161363.
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 FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1 to S1) 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: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180458: FOCUS 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/K180458
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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