510(k) · Cleared
ClearedPressON Pro Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexus Spine, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 28, 2016 as substantially equivalent to K133287 (Nexus Spine, LLC, 2014) and 2 other predicates after a 96-day review. Its family tree reaches back 7 generations to 2004.
- Decided
- Jun 28, 2016
- Review
- 96 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K040583 (2004). 32 ancestors in all, the oldest K955348 (1996). No later device cites it as a predicate yet.
- Root · 7 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 4 generations backK052054 TSRH Spinal SystemMedtronic Sofamor Danek · 2005
- 3 generations backK072317 Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2007 · Recalled
- 2 generations backK081080 TSRH Spinal SystemMedtronic Sofamor Danek · 2008
- 1 generation backK133287 Presson Spinal Fixation SystemNexus Spine, LLC · 2014
- This deviceK160820 PressON Pro Spinal Fixation SystemNexus Spine, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −4 | K052054 | TSRH Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −3 | K072317 | Modification to:TSRH Spinal System | Medtronic Sofamor Danek USA, Inc. | 2007 | 4 |
| −2 | K081080 | TSRH Spinal System | Medtronic Sofamor Danek | 2008 | — |
| −1 | K133287 | Presson Spinal Fixation System | Nexus Spine, LLC | 2014 | — |
| 0 (this device) | K160820 | PressON Pro Spinal Fixation System | Nexus Spine, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K133287 | Presson Spinal Fixation SystemSummary page 5…evice is substantially equivalent to the following devices: PressON Pedicle Screw System (Primary Predicate) Marketed and distributed by Nexus Spine, LLC 510(K) Number: K133287 Expedium MOSS Miami Spinal System Marketed and distributed by Johnson & Johnson 510(K) Number K103490 Alpine Pedicle Screw Syst… | 2014 |
| * | K103490 | Expedium Spine System, Moss Miami Spine SystemSummary page 5…icate) Marketed and distributed by Nexus Spine, LLC 510(K) Number: K133287 Expedium MOSS Miami Spinal System Marketed and distributed by Johnson & Johnson 510(K) Number K103490 Alpine Pedicle Screw System Marketed and distributed by Sanacor LLC 510(K) Number K090477 The PressON Pro Spinal Fixation Syste… | 2011 |
| * | K090477 | Alpine Pedicle Screw SystemSummary page 5…iami Spinal System Marketed and distributed by Johnson & Johnson 510(K) Number K103490 Alpine Pedicle Screw System Marketed and distributed by Sanacor LLC 510(K) Number K090477 The PressON Pro Spinal Fixation System is composed of pedicle screws and rods. These components can be assembled and implanted u… | 2009 |
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 12 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 4 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. 2016, 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 PressON Pro Spinal Fixation System is a posterior, non-cervical pedicle screw system 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: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal tumor, and failed previous fusion (pseudarthrosis).
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/K160820 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160820: PressON Pro Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160820
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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