510(k) · Cleared
ClearedGso GS1 Cannulated Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gold Standard Orthopaedics, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Mar 11, 2013 as substantially equivalent to K070966 (Gold Standard Orthopaedics, LLC, 2007) and 2 other predicates after a 118-day review. Its family tree reaches back 14 generations to 1985.
- Decided
- Mar 11, 2013
- Review
- 118 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K853033 (1985). 111 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations between
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 1 generation backK121020 Viper SystemDepuy Spine, Inc. · 2012
- This deviceK123487 Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC · 2013
Show all 14 generations
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 1 generation backK121020 Viper SystemDepuy Spine, Inc. · 2012
- This deviceK123487 Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −13 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −12 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −11 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −10 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −9 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −8 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −7 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −3 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −1 | K121020 | Viper System | Depuy Spine, Inc. | 2012 | — |
| 0 (this device) | K123487 | Gso GS1 Cannulated Screw System | Gold Standard Orthopaedics, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 13 | 0 |
| 2002 | 5 | 0 |
| 2003 | 7 | 0 |
| 2004 | 13 | 0 |
| 2005 | 10 | 0 |
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 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 MNH? 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? (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 |
|---|---|---|---|
| * | K070966 | Gso GS1 Spinal SystemSummary page 3…Cannulated Screw System has the same indications, a similar design, and is manufactured from the same materials as the GSO GSI Spinal System cleared in 1K070966. The cannulated screw components of the GSO GSI Cannulated Screxv System are similar in design to the cannulated screw co… | 2007 |
| * | K121020 | Viper SystemSummary page 1…R 888.3070-MINH, MNI Legally Marketed Devices to \vhich Substantial Equivalence is claimed: GSO GS1 Spinal System (1(070966) DePuy Spine VIPER System (1K121 020) Medtronic Sofamor Danek CD Horizon Spinal System (1(032265) Device Description: The GSO GS1 Spinal System cons… | 2012 |
| * | K032265 | CD Horizon Spinal SystemSummary page 1…Equivalence is claimed: GSO GS1 Spinal System (1(070966) DePuy Spine VIPER System (1K121 020) Medtronic Sofamor Danek CD Horizon Spinal System (1(032265) Device Description: The GSO GS1 Spinal System consists of rods, screws, hooks, and :connecting components that… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 111 ancestors have a recall of any class.
- 1 other device also cites its predicate K070966.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GSO OSI Cannulated Screw 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 GSI Cannulated Screw System should be removed after fusion. As a pedicle screw system, the GSO GSI Cannulated Screw System is intended for patients…
Read the full statement (311 words)
The GSO OSI Cannulated Screw 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 GSI Cannulated Screw System should be removed after fusion.
As a pedicle screw system, the GSO GSI Cannulated Screw 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 (133 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 GSI Cannulated Screw 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 tumnor, and failed previous fusion (pseudartlirosis).
When used as a posterior, non-cervical, non-pedicle screw and/or book fixation system, the GSO GSI Cannulated Screw 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 GSI screws are intended for sacral/iliac attachment only and the GSO GSI hooks and crosslinks are intended for thoracic and/or lumbar use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123487 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123487: Gso GS1 Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123487
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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