510(k) · Cleared
ClearedSolanas Avalon Posterior Fixation 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 Jul 12, 2011 as substantially equivalent to K093434 (Medtronic Sofamor Danek, 2009) and 2 other predicates after an 85-day review. Its family tree reaches back 13 generations to 2001. 5 later devices descend from it.
- Decided
- Jul 12, 2011
- Review
- 85 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K003155 (2001). 97 ancestors in all, the oldest K841189 (1984). 5 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations between
- 3 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 2 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 1 generation backK093434 Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek · 2009
- This deviceK111076 Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK182837 M.U.S.T. Mini ExtensionMedacta International S.A. · 2019
- Descendant · cites it directly · 1 of its ownK162266 The Cranial Fusion SystemLife Spine, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK203125 Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK203149 M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020
- Descendant · 2 generations on · 0 of its ownK200896 Solstice CCILife Spine, Inc. · 2020
Show all 13 generations
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations backK012254 VBROsteotech, Inc. · 2001
- 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 8 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 4 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 3 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 2 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 1 generation backK093434 Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek · 2009
- This deviceK111076 Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K182837M.U.S.T. Mini ExtensionMedacta International S.A. · 2019 · cites it directly1descendant
- K162266The Cranial Fusion SystemLife Spine, Inc. · 2017 · cites it directly1descendant
- K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · cites it directly0descendants
- K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A. · 2020 · 2 generations on0descendants
- K200896Solstice CCILife Spine, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −12 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −11 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −8 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −4 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −3 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −2 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −1 | K093434 | Vertex Reconstruction System and Vertex Select Reconstruction System | Medtronic Sofamor Danek | 2009 | — |
| 0 (this device) | K111076 | Solanas Avalon Posterior Fixation System | Alphatec Spine, Inc. | 2011 | — |
| +1 | K182837 | M.U.S.T. Mini Extension | Medacta International S.A. | 2019 | — |
| +1 | K162266 | The Cranial Fusion System | Life Spine, Inc. | 2017 | — |
| +1 | K203125 | Invictus™ OCT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +2 | K203149 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | 2020 | — |
| +2 | K200896 | Solstice CCI | Life Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 8 | 0 |
| 2003 | 7 | 0 |
| 2004 | 22 | 0 |
| 2005 | 10 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 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 |
|---|---|---|---|
| * | K093434 | Vertex Reconstruction System and Vertex Select Reconstruction SystemSummary page 1…owing predicate devices: System Clearance Company Vertex Reconstruction System K093434 Medtronic Ascent POCT System K080394 Blackstone Medical… | 2009 |
| * | K080394 | Blackstone Ascent Posterior Occipital Cervico-Thoracic (Poct) SystemSummary page 1…Company Vertex Reconstruction System K093434 Medtronic Ascent POCT System K080394 Blackstone Medical Solanas Posterior Stabilization K07 1380 Alphatec Spi… | 2008 |
| * | K071380 | Modification to Solanas Posterior Stabilization SystemSummary page 1…Medtronic Ascent POCT System K080394 Blackstone Medical Solanas Posterior Stabilization K07 1380 Alphatec Spine Intended Use The SOLANAS AVALON Posterior Fixation System is intended to promote fusion of the c… | 2007 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 8 of the 97 ancestors have a recall of any class.
- Of its descendants, K182837 (Medacta International S.A., 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K093434.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 SOLANAS AVALON Posterior Fixation System is intended to promote fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3). It is intended that this device, in any system configuration, be removed after development of solid fusion mass. The occipital bone screws are limited to occipital fixation only. Hook components are indicated for use at C1-C7. Polyaxial pedicle screws are intended for placement only in T1-T3 for…
Read the full statement (194 words)
The SOLANAS AVALON Posterior Fixation System is intended to promote fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3). It is intended that this device, in any system configuration, be removed after development of solid fusion mass. The occipital bone screws are limited to occipital fixation only. Hook components are indicated for use at C1-C7. Polyaxial pedicle screws are intended for placement only in T1-T3 for anchoring of the system. These screws and offset connectors are not intended to be placed in the cervical spine. The components in the Solanas Posterior Fixation 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. However, the components of the SOLANAS AVALON Posterior Fixation System are not intended to work with the Zodiac System.
It is intended for the following:
1. Degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
2. Spondylolisthesis.
3. Spinal stenosis.
4. Fracture/Dislocation.
5. Atlanto/Axial fracture with instability.
6. Revision of previous cervical spine surgery.
7. Tumors.
8. Occipito-cervical dislocation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111076: Solanas Avalon Posterior 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/K111076
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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