510(k) · Cleared
ClearedG Surgical Marksman MIS 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 Aug 25, 2016 as substantially equivalent to K122901 (Orthofix, 2012) and 3 other predicates after an 84-day review. Its family tree reaches back 10 generations to 1998. 3 later devices descend from it.
- Decided
- Aug 25, 2016
- Review
- 84 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K980447 (1998). 97 ancestors in all, the oldest K901587 (1990). 3 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
- 6 generations between
- 3 generations backK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled
- 2 generations backK100044 Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010
- 1 generation backK122901 Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix · 2012
- This deviceK161516 G Surgical Marksman MIS SystemG Surgical, LLC · 2016
- Descendant · cites it directly · 1 of its ownK193219 G Surgical Marksman SystemG Surgical, LLC · 2019
- Descendant · cites it directly · 0 of its ownK240737 G Surgical Marksman MIS SystemG Surgical, LLC · 2024
- Descendant · cites it directly · 0 of its ownK230063 G Surgical Marksman Spinal Deformity SystemG Surgical, LLC · 2023
Show all 10 generations
- Root · 10 generations backK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
- 9 generations backK013558 Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc. · 2002
- 8 generations backK022399 Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc. · 2002
- 7 generations backK030241 Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2003
- 6 generations backK080407 Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc. · 2008 · Recalled
- 5 generations backK081684 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · Recalled
- 4 generations backK082797 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008
- 3 generations backK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled
- 2 generations backK100044 Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone · 2010
- 1 generation backK122901 Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix · 2012
- This deviceK161516 G Surgical Marksman MIS SystemG Surgical, LLC · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K980447 | Depuy Motech Moss Miami Spinal System | DePuy Orthopaedics, Inc. | 1998 | — |
| −9 | K013558 | Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw | Blackstone Medical, Inc. | 2002 | — |
| −8 | K022399 | Blackstone Spinal Fixation System Spacer | Blackstone Medical, Inc. | 2002 | — |
| −7 | K030241 | Modification to Blackstone Spinal Fixation System | Blackstone Medical, Inc. | 2003 | — |
| −6 | K080407 | Blackstone SFS Parallel Rod Connectors | Blackstone Medical, Inc. | 2008 | 1 |
| −5 | K081684 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | 2008 | 3 |
| −4 | K082797 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | 2008 | — |
| −3 | K092624 | Firebird Spinal Fixation System | Blackstone Medical, Inc. | 2009 | 1 |
| −2 | K100044 | Firebird Spinal Fixation System, Firebird Side-Loading Body | Blackstone | 2010 | — |
| −1 | K122901 | Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System | Orthofix | 2012 | — |
| 0 (this device) | K161516 | G Surgical Marksman MIS System | G Surgical, LLC | 2016 | — |
| +1 | K193219 | G Surgical Marksman System | G Surgical, LLC | 2019 | — |
| +1 | K240737 | G Surgical Marksman MIS System | G Surgical, LLC | 2024 | — |
| +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 |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 5 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 8 | 0 |
| 2004 | 6 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (4)
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 |
|---|---|---|---|
| * | K122901 | Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemSummary page 5…F136) and Cobalt Chrome (per ASTM F1537). Predicate Devices: Primary: Firebird with Phoenix MIS Spinal Fixation System (Orthoifix, Inc. – K122901) Additional: Zodiac® Spinal Fixation System (Alphatec Spine Inc. – K100685), Mo… | 2012 |
| * | K100685 | Zodiac Polyaxial Spinal Fixation SystemSummary page 5…(Orthoifix, Inc. – K122901) Additional: Zodiac® Spinal Fixation System (Alphatec Spine Inc. – K100685), Moss Miami™ Spinal System (DePuy AcroMed, Inc. – K022623) and Optima™ Spinal System (U&I Corporation –… | 2010 |
| * | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Summary page 5…Additional: Zodiac® Spinal Fixation System (Alphatec Spine Inc. – K100685), 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 5…Inc. – K100685), 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 MIS System constructs inc… | 2005 |
What descends from it? (3)
3 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?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 11 of the 97 ancestors have a recall of any class.
- Of its descendants, K193219 (G Surgical, LLC, 2019) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K122901.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 MIS 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.…
Read the full statement (101 words)
The G Surgical Marksman MIS 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. The G Surgical Marksman MIS System can be used in an open approach or a percutaneous approach with MIS instrumentation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161516: G Surgical Marksman MIS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161516
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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