510(k) · Cleared
ClearedSolanas® Posterior Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Nov 30, 2017 as substantially equivalent to K071380 (Alphatec Spine, Inc., 2007) and 1 other predicate after a 16-day review. Its family tree reaches back 15 generations to 2001. 5 later devices descend from it.
- Decided
- Nov 30, 2017
- Review
- 16 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K003155 (2001). 113 ancestors in all, the oldest K841189 (1984). 5 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations between
- 3 generations backK123656 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK133556 Virage Oct Spinal Fixation SystemZimmer Spine, Inc. · 2014 · Recalled
- 1 generation backK150918 PASS OCT Spinal SystemMedicrea International SA · 2015
- This deviceK173522 Solanas® Posterior Stabilization SystemAlphatec Spine, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK191185 Solanas® Posterior OCT Fixation SystemAlphatec Spine · 2019
- Descendant · 2 generations on · 3 of its ownK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
- Descendant · 4 generations on · 0 of its ownK261284 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal…Alphatec Spine, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK203125 Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
Show all 15 generations
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations backK012254 VBROsteotech, Inc. · 2001
- 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 10 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 6 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 5 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 4 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 3 generations backK123656 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK133556 Virage Oct Spinal Fixation SystemZimmer Spine, Inc. · 2014 · Recalled
- 1 generation backK150918 PASS OCT Spinal SystemMedicrea International SA · 2015
- This deviceK173522 Solanas® Posterior Stabilization SystemAlphatec Spine, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine · 2019 · cites it directly4descendants
- K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 2 generations on3descendants
- K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc. · 2026 · 3 generations on1descendant
- K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026 · 4 generations on0descendants
- K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −14 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −13 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −10 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −6 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −5 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −4 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −3 | K123656 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −2 | K133556 | Virage Oct Spinal Fixation System | Zimmer Spine, Inc. | 2014 | 2 |
| −1 | K150918 | PASS OCT Spinal System | Medicrea International SA | 2015 | — |
| 0 (this device) | K173522 | Solanas® Posterior Stabilization System | Alphatec Spine, Inc. | 2017 | — |
| +1 | K191185 | Solanas® Posterior OCT Fixation System | Alphatec Spine | 2019 | — |
| +2 | K200936 | Invictus™ CT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +3 | K252597 | Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For… | Alphatec Spine, Inc. | 2026 | — |
| +4 | K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation… | Alphatec Spine, Inc. | 2026 | — |
| +2 | K203125 | Invictus™ OCT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 8 | 0 |
| 2001 | 10 | 0 |
| 2002 | 11 | 0 |
| 2003 | 7 | 0 |
| 2004 | 19 | 0 |
| 2005 | 10 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K071380 | Modification to Solanas Posterior Stabilization SystemSummary page 4…Class II Product Code: NKB, KWP III. PREDICATE DEVICE Alphatec Spine, Inc., Solanas® Posterior Stabilization System, K071380 (Primary Predicate) Medicrea International, PASS OCT Spinal System, K150918 (Additional Predicate) IV. DEVICE DESCRIPTI… | 2007 |
| * | K150918 | PASS OCT Spinal SystemSummary page 4…III. PREDICATE DEVICE Alphatec Spine, Inc., Solanas® Posterior Stabilization System, K071380 (Primary Predicate) Medicrea International, PASS OCT Spinal System, K150918 (Additional Predicate) IV. DEVICE DESCRIPTION The Solanas® Posterior Stabilization System is a spinal fixation system i… | 2015 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191185 | Solanas® Posterior OCT Fixation System | 2019 | 4 |
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 16 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 8 of the 113 ancestors have a recall of any class.
- Of its descendants, K191185 (Alphatec Spine, 2019) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K071380.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine. The components in the Solanas® Posterior Stabilization System can be linked to the components in the Zodiac…
Read the full statement (135 words)
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine.
The components in the Solanas® Posterior Stabilization System can be linked to the components in the Zodiac Polyaxial Spinal Fixation System offered by Alphatec Spine using the Axial Rod Connectors, Parallel Rod Connectors or Transitional Rods.
• Degenerative Disc Disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
• Spondylolisthesis
• Spinal Stenosis
• Fracture/Dislocation
• Atlanto/Axial fracture with instability
• Revision of previous cervical spine surgery
• Tumors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173522 · printed Nov 4, 2026
Cite this page
510(k) Report. “K173522: Solanas® Posterior Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K173522
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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