510(k) · Cleared
Recalled · 2010Modification to Solanas 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 Aug 20, 2007 as substantially equivalent to K052201 (Alphatec Spine, Inc., 2005) after a 95-day review. Its family tree reaches back 5 generations to 1985. 18 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 20, 2007
- Review
- 95 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 5 generations to K853033 (1985). 10 ancestors in all. 18 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 4 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 3 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 2 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 1 generation backK052201 Solanas Posterior Stabilization SystemAlphatec Spine, Inc. · 2005 · Recalled
- This deviceK071380 Modification to Solanas Posterior Stabilization SystemAlphatec Spine, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK173522 Solanas® Posterior Stabilization SystemAlphatec Spine, Inc. · 2017
- Descendant · cites it directly · 5 of its ownK111076 Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc. · 2011
- Descendant · 2 generations on · 4 of its ownK191185 Solanas® Posterior OCT Fixation SystemAlphatec Spine · 2019
- Descendant · 3 generations on · 3 of its ownK200936 Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK133214 Blackbird Spinal SystemChoicespine, LP · 2014
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc. · 2017 · cites it directly5descendants
- K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc. · 2011 · cites it directly5descendants
- K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine · 2019 · 2 generations on4descendants
- K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 3 generations on3descendants
- K133214Blackbird Spinal SystemChoicespine, LP · 2014 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −4 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −3 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −2 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −1 | K052201 | Solanas Posterior Stabilization System | Alphatec Spine, Inc. | 2005 | 3 |
| 0 (this device) | K071380 | Modification to Solanas Posterior Stabilization System | Alphatec Spine, Inc. | 2007 | — |
| +1 | K173522 | Solanas® Posterior Stabilization System | Alphatec Spine, Inc. | 2017 | — |
| +1 | K111076 | Solanas Avalon Posterior Fixation System | Alphatec Spine, Inc. | 2011 | — |
| +2 | K191185 | Solanas® Posterior OCT Fixation System | Alphatec Spine | 2019 | — |
| +3 | K200936 | Invictus™ CT Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +1 | K133214 | Blackbird Spinal System | Choicespine, LP | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (1)
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 2…vices: Trade/Proprietary Name Manufacturer Clearance SOLANASTM Posterior Alphatec Spine, Inc. K052201 Stabilization System Performance Data: Mechanical and dynamic testing of the posterior stabilization system was performed. T… | 2005 |
What descends from it? (18)
See all 185 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 1, 2010 | Not classified | Z-0932-2012 | Device Design | These lots were not manufactured correctly in that the instrument does not have the durability required to repeatedly perform over its full service life and, therefore, may experience breakage in the tips. |
| Aug 5, 2009 | Not classified | Z-0502-2010 | Process control | Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees. |
| Aug 5, 2009 | Not classified | Z-0503-2010 | Process control | Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K173522 (Alphatec Spine, Inc., 2017) has gone furthest, with 5 descendants of its own.
- 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. 2007, 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 Cl-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 Cl-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 disk 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/K071380 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071380: Modification to 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/K071380
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