510(k) · Cleared
ClearedG Surgical Marksman System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G Surgical, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 17, 2019 as substantially equivalent to K161516 (G Surgical, LLC, 2016) and 4 other predicates after a 26-day review. Its family tree reaches back 16 generations to 1985. 1 later device descends from it.
- Decided
- Dec 17, 2019
- Review
- 26 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 16 generations to K853033 (1985). 259 ancestors in all, the oldest K841189 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations between
- 3 generations backK120696 Tiger Spine SystemCorelink, LLC · 2012
- 2 generations backK131250 Tiger Spine SystemCorelink, LLC · 2013
- 1 generation backK133369 Tiger Spine SystemCorelink, LLC · 2014
- This deviceK193219 G Surgical Marksman SystemG Surgical, LLC · 2019
- Descendant · cites it directly · 0 of its ownK230063 G Surgical Marksman Spinal Deformity SystemG Surgical, LLC · 2023
Show all 16 generations
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 15 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 14 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 13 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 12 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 11 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 10 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 9 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 8 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 7 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 5 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 4 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 3 generations backK120696 Tiger Spine SystemCorelink, LLC · 2012
- 2 generations backK131250 Tiger Spine SystemCorelink, LLC · 2013
- 1 generation backK133369 Tiger Spine SystemCorelink, LLC · 2014
- This deviceK193219 G Surgical Marksman SystemG Surgical, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −15 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −14 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −13 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −12 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −11 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −10 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −9 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −8 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −7 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −5 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −4 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −3 | K120696 | Tiger Spine System | Corelink, LLC | 2012 | — |
| −2 | K131250 | Tiger Spine System | Corelink, LLC | 2013 | — |
| −1 | K133369 | Tiger Spine System | Corelink, LLC | 2014 | — |
| 0 (this device) | K193219 | G Surgical Marksman System | G Surgical, LLC | 2019 | — |
| +1 | K230063 | G Surgical Marksman Spinal Deformity System | G Surgical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 7 | 0 |
| 1997 | 8 | 0 |
| 1998 | 14 | 0 |
| 1999 | 15 | 0 |
| 2000 | 21 | 0 |
| 2001 | 21 | 0 |
| 2002 | 18 | 0 |
| 2003 | 14 | 0 |
| 2004 | 22 | 0 |
| 2005 | 18 | 0 |
| 2006 | 11 | 0 |
| 2007 | 10 | 0 |
| 2008 | 12 | 0 |
| 2009 | 10 | 0 |
| 2010 | 13 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (5)
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 |
|---|---|---|---|
| * | K161516 | G Surgical Marksman MIS SystemSummary page 4…-4V ELI titanium alloy (ASTM F136) and Cobalt Chrome (per ASTM F1537). Primary Predicate: G Surgical Marksman MIS System (G Surgical LLC – K161516) Additional Predicates: G Surgical Pedicle System (G Surgical LLC – K081041), Tiger® Spine System (Cor… | 2016 |
| * | K081041 | GPS, G Surgical Pedicle SystemSummary page 4…(per ASTM F1537). Primary Predicate: G Surgical Marksman MIS System (G Surgical LLC – K161516) Additional Predicates: G Surgical Pedicle System (G Surgical LLC – K081041), Tiger® Spine System (CoreLink LLC – K133369), Moss Miami™ Spinal System (DePuy… | 2008 |
| * | K133369 | Tiger Spine SystemSummary page 4…em (G Surgical LLC – K161516) Additional Predicates: G Surgical Pedicle System (G Surgical LLC – K081041), Tiger® Spine System (CoreLink LLC – K133369), Moss Miami™ Spinal System (DePuy AcroMed, Inc. – K022623) and Optima™ Spinal System (U&I Corporation –… | 2014 |
| * | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Summary page 4…Surgical LLC – K081041), Tiger® Spine System (CoreLink LLC – K133369), Moss Miami™ Spinal System (DePuy AcroMed, Inc. – K022623) and Optima™ Spinal System (U&I Corporation – K051971) Performance Data: Mechanical testing of wo… | 2002 |
| * | K051971 | Optima Spinal SystemSummary page 4…LLC – K133369), Moss Miami™ Spinal System (DePuy AcroMed, Inc. – K022623) and Optima™ Spinal System (U&I Corporation – K051971) Performance Data: Mechanical testing of worst case G Surgical Marksman System constructs include… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230063 | G Surgical Marksman Spinal Deformity System | 2023 | 0 |
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 34 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 19 of the 259 ancestors have a recall of any class.
- Of its descendants, K230063 (G Surgical, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K161516.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The G Surgical Marksman System is intended to provide immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193219: G Surgical Marksman System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193219
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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