510(k) · Cleared
Recalled · 2010Solanas Posterior Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Nov 10, 2005 as substantially equivalent to K002733 (Depuyacromed, 2000) after a 90-day review. Its family tree reaches back 4 generations to 1985. 36 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 10, 2005
- Review
- 90 days
- Class
- Class II
- Product code
- KWP
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K853033 (1985). 9 ancestors in all. 36 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 3 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 2 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 1 generation backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- This deviceK052201 Solanas Posterior Stabilization SystemAlphatec Spine, Inc. · 2005
- Descendant · cites it directly · 18 of its ownK071380 Modification to Solanas Posterior Stabilization SystemAlphatec Spine, Inc. · 2007 · Recalled
- Descendant · cites it directly · 6 of its ownK071905 Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC · 2007
- Descendant · 2 generations on · 5 of its ownK173522 Solanas® Posterior Stabilization SystemAlphatec Spine, Inc. · 2017
- Descendant · 2 generations on · 5 of its ownK111076 Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK092656 Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc. · 2009
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K071380Modification to Solanas Posterior Stabilization SystemAlphatec Spine, Inc. · 2007 · cites it directly18descendants
- K071905Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, LLC · 2007 · cites it directly6descendants
- K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc. · 2017 · 2 generations on5descendants
- K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc. · 2011 · 2 generations on5descendants
- K092656Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc. · 2009 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −3 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −2 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −1 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| 0 (this device) | K052201 | Solanas Posterior Stabilization System | Alphatec Spine, Inc. | 2005 | — |
| +1 | K071380 | Modification to Solanas Posterior Stabilization System | Alphatec Spine, Inc. | 2007 | 3 |
| +1 | K071905 | Posterior Cervicothoracic Spinal Fixation System (PCFS) | Lanx, LLC | 2007 | — |
| +2 | K173522 | Solanas® Posterior Stabilization System | Alphatec Spine, Inc. | 2017 | — |
| +2 | K111076 | Solanas Avalon Posterior Fixation System | Alphatec Spine, Inc. | 2011 | — |
| +2 | K092656 | Lanx Posterior Cervicothoracic Spinal Fixation System | Lanx, Inc. | 2009 | — |
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 |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemSummary page 1…rgery 7. Tumors VII Substantial Equivalence: The SOLANAS TM Posterior Stabilization System is substantially equivalent to Summit TM system (K002733). VIII Performance Data: Mechanical testing of the SOLANAS TM Posterior Stabilization System was performed and… | 2000 |
What descends from it? (36)
See all 368 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071380 | Modification to Solanas Posterior Stabilization System | 2007 | 18 |
| K071905 | Posterior Cervicothoracic Spinal Fixation System (PCFS) | 2007 | 6 |
| K122292 | Reliance Posterior Cervical- Thoracic System | 2012 | 4 |
| K112025 | Sure Lok Mini Posterior Cervical/Upper Thoracic System | 2011 | 4 |
| K133214 | Blackbird Spinal System | 2014 | 3 |
| K100191 | Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS) | 2010 | 3 |
| K120467 | Spinal Elements Posterior Cervical/Thoracic Spinal System | 2012 | 1 |
| K131119 | Solanas Posterior Stabilization System | 2013 | 0 |
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 20 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K071380 (Alphatec Spine, Inc., 2007) has gone furthest, with 18 descendants of its own.
- 15 other devices also cite its predicate K002733.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Indications for Use: 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 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.
1. Degenerative disk 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052201: 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/K052201
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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