510(k) · Cleared
ClearedGso GS1 Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gold Standard Orthopaedics, LLC · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jul 20, 2007 as substantially equivalent to K031833 (Medtronic Sofamor Danek, 2003) and 1 other predicate after a 106-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Jul 20, 2007
- Review
- 106 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010515 (2001). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010515 Modification to Synergy Spinal SystemInterpore Cross Intl. · 2001
- This deviceK070966 Gso GS1 Spinal SystemGold Standard Orthopaedics, LLC · 2007
- Descendant · cites it directly · 0 of its ownK123487 Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC · 2013
- Descendant · cites it directly · 0 of its ownK091359 Gso PCT Spinal SystemGold Standard Orthopaedics, LLC · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010515 | Modification to Synergy Spinal System | Interpore Cross Intl. | 2001 | — |
| 0 (this device) | K070966 | Gso GS1 Spinal System | Gold Standard Orthopaedics, LLC | 2007 | — |
| +1 | K123487 | Gso GS1 Cannulated Screw System | Gold Standard Orthopaedics, LLC | 2013 | — |
| +1 | K091359 | Gso PCT Spinal System | Gold Standard Orthopaedics, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 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 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? (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 |
|---|---|---|---|
| * | K031833 | Modification to CD Horizon Spinal SystemSummary page 2…GSO GSI Spinal System has a similar design and is manufactured from the same materials as the CD Horizon Spinal System - Medtronic Sofamor Danek, Inc. (1K031833) and the Synergy Spinal System - Interpore Cross International (1(010515). When used as a pedicle screw system, the GSO G… | 2003 |
| * | K010515 | Modification to Synergy Spinal SystemSummary page 1…uivalence is claimed: CD Horizon Spinal System - Medtronic Sofamor Danek, Inc. (1031833) * Synergy Spinal System - Interpore Cross International (1(010515) 7. Device Description: The GSO GS1 Spinal System consists of rods, screws, hooks, and adjustable crosslin… | 2001 |
What descends from it? (2)
2 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?
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
The GSO GS1 Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO GS1 Spinal System should be removed after fusion. As a pedicle screw system, the GSO GS 1 Spinal System is intended for patients: (a) having severe…
Read the full statement (322 words)
The GSO GS1 Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO GS1 Spinal System should be removed after fusion.
As a pedicle screw system, the GSO GS 1 Spinal System is intended for patients: (a) having severe spondylolisthesis (Grade 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass.
In addition, when used as a pedicle screw system, the GSO GS 1 Spinal System is indicated for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as a posterior, non-cervical, non-pedicle screw and/pr hook fixation system, the GSO GSl Spinal System is indicated for:
1. Degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2. Idiopathic scoliosis
3. Kyphotic deformities of the spine
4. Paralytic scoliosis and/or pelvis obliquity
5. Vertebral fracture or dislocation
6. Neuromuscular scoliosis associated with pelvic obliquity
7. Vertebral fracture or dislocation
8. Tumors
9. Spondylolisthesis
10. Stenosis
11. Pseudarthrosis
12. Unsuccessful previous attempts at spinal fusion
For posterior, non-pedicle, screw use, the GSO GS1 screws are intended for sacral/iliac attachment only and the GSO GSI1 hooks and crosslinks are intended for thoracic and/or lumbar use only.
In all cases, instrumentation must be at least 1 cm from any major vessel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070966 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070966: Gso GS1 Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070966
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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