510(k) · Cleared
Recalled · Class II · 2014Solanas 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 May 21, 2013 as substantially equivalent to K052201 (Alphatec Spine, Inc., 2005) and 1 other predicate after a 29-day review. Its family tree reaches back 6 generations to 1985. It has been recalled once.
- Decided
- May 21, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K853033 (1985). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 5 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 4 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 3 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 2 generations backK052201 Solanas Posterior Stabilization SystemAlphatec Spine, Inc. · 2005 · Recalled
- 1 generation backK071380 Modification to Solanas Posterior Stabilization SystemAlphatec Spine, Inc. · 2007 · Recalled
- This deviceK131119 Solanas Posterior Stabilization SystemAlphatec Spine, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −5 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −4 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −3 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −2 | K052201 | Solanas Posterior Stabilization System | Alphatec Spine, Inc. | 2005 | 3 |
| −1 | K071380 | Modification to Solanas Posterior Stabilization System | Alphatec Spine, Inc. | 2007 | 3 |
| 0 (this device) | K131119 | Solanas Posterior Stabilization System | Alphatec Spine, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K052201 | Solanas Posterior Stabilization SystemSummary page 1…Classification Product Code: KWP, MNI, NKI3 VIII. Predicate Devices: Solanas Posterior Stabilization System, K052201 and Modification to Solanas Posterior… | 2005 |
| * | K071380 | Modification to Solanas Posterior Stabilization SystemSummary page 1…and Modification to Solanas Posterior Stabilization System, K07 1380 IX. IDescriPtion: The Solanas Posterior Stabilization System facilitates the Surgical correction of spinal… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2014 | Class II | Z-2092-2014 | Unknown/Undetermined by firm | Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 7 other devices also cite its predicate K052201.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 development of solid fusion mass. Hook components are indicated for use at Cl-C7. Polyaxial pedicle screws and offset connectors are limited to the thoracic spine (T1-T3) in treating thoracic conditions only. These screws and offset connectors are not intended to be placed in the cervical spine. The components in the SOLANAS Posterior stabilization system can be linked to the…
Read the full statement (139 words)
It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook components are indicated for use at Cl-C7. Polyaxial pedicle screws and offset connectors are limited to the thoracic spine (T1-T3) in treating thoracic conditions only. These screws and offset connectors are not intended to be placed 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
1. Degenerative disc disease (DOD), 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. AtlantolAxial fracture with instability
6. Revision of previous cervical spine surgery
7. Tumors
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131119: Solanas Posterior Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131119
Report an extraction error
Are you the manufacturer?
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