510(k) · Cleared
ClearedQUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · NKG Posterior Cervical Screw System
Cleared on Mar 14, 2024 as substantially equivalent to K161591 (Globus Medical, Inc., 2016) and 4 other predicates after a 265-day review. Its family tree reaches back 21 generations to 2004. 9 of the 707 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Mar 14, 2024
- Review
- 265 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 21 generations to K040583 (2004). 704 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 1 citing it directly. 9 of the 707 devices in this family, counting this one, have a Class I recall.
- Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations between
- 3 generations backK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- 2 generations backK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- 1 generation backK200047 ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc. · 2020 · Recalled
- This deviceK231850 QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS®…Globus Medical, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK252327 CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025
- Descendant · 2 generations on · 0 of its ownK254045 CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2026
Show all 21 generations
- Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 20 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 18 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 17 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 16 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 15 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 14 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 13 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 12 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 11 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 10 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 9 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 8 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 7 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 6 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 5 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
- 4 generations backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
- 3 generations backK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- 2 generations backK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- 1 generation backK200047 ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc. · 2020 · Recalled
- This deviceK231850 QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS®…Globus Medical, Inc. · 2024
Class I recalls in this family
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 |
|---|---|---|---|---|---|
| −21 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −20 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −19 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −18 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −17 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −16 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −15 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −14 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −13 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −12 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −11 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −10 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −9 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −8 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −7 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −6 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −5 | K153203 | Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| −4 | K161591 | QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| −3 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| −2 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
| −1 | K200047 | ExcelsiusGPS Cranial 1.0 Module | Globus Medical, Inc. | 2020 | 3 |
| 0 (this device) | K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments | Globus Medical, Inc. | 2024 | — |
| +1 | K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | 2025 | — |
| +2 | K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior… | CarboFix Orthopedics, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 15 | 0 |
| 1996 | 17 | 0 |
| 1997 | 12 | 0 |
| 1998 | 18 | 0 |
| 1999 | 21 | 0 |
| 2000 | 27 | 0 |
| 2001 | 42 | 1 |
| 2002 | 32 | 0 |
| 2003 | 40 | 0 |
| 2004 | 63 | 0 |
| 2005 | 50 | 0 |
| 2006 | 35 | 0 |
| 2007 | 30 | 0 |
| 2008 | 62 | 0 |
| 2009 | 35 | 0 |
| 2010 | 33 | 1 |
| 2011 | 33 | 0 |
| 2012 | 15 | 0 |
| 2013 | 21 | 0 |
| 2014 | 13 | 0 |
| 2015 | 16 | 2 |
| 2016 | 3 | 1 |
| 2017 | 5 | 1 |
| 2018 | 1 | 1 |
| 2019 | 1 | 1 |
| 2020 | 1 | 0 |
| 2021 | 3 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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.
9 devices in this family have a Class I recall. 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 NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 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 |
|---|---|---|---|
| * | K161591 | QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsSummary page 6…882.4560 Stereotaxic Instruments Product Code: OLO Regulatory Class: II, Panel Code: 87 Primary Predicate: QUARTEX® Spinal System (K161591) Addtl Predicates: QUARTEX® Spinal System (K211957) ExcelsiusGPS® (K171651, K200047) Excels… | 2016 |
| * | K211957 | QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsSummary page 6…Product Code: OLO Regulatory Class: II, Panel Code: 87 Primary Predicate: QUARTEX® Spinal System (K161591) Addtl Predicates: QUARTEX® Spinal System (K211957) ExcelsiusGPS® (K171651, K200047) ExcelsiusHub™ (K211616) Reference Device: CREO® Stabiliza… | 2021 |
| * | K171651 | Excelsius GPSSummary page 6…atory Class: II, Panel Code: 87 Primary Predicate: QUARTEX® Spinal System (K161591) Addtl Predicates: QUARTEX® Spinal System (K211957) ExcelsiusGPS® (K171651, K200047) ExcelsiusHub™ (K211616) Reference Device: CREO® Stabilization System (K143633, K124058, K191835) Pu… | 2017 |
| * | K200047 | ExcelsiusGPS Cranial 1.0 ModuleSummary page 6…ss: II, Panel Code: 87 Primary Predicate: QUARTEX® Spinal System (K161591) Addtl Predicates: QUARTEX® Spinal System (K211957) ExcelsiusGPS® (K171651, K200047) ExcelsiusHub™ (K211616) Reference Device: CREO® Stabilization System (K143633, K124058, K191835) Purpose: Th… | 2020 |
| * | K211616 | ExcelsiusHubSummary page 6…QUARTEX® Spinal System (K161591) Addtl Predicates: QUARTEX® Spinal System (K211957) ExcelsiusGPS® (K171651, K200047) ExcelsiusHub™ (K211616) Reference Device: CREO® Stabilization System (K143633, K124058, K191835) Purpose: The purpose of this submission is to request… | 2021 |
| † | K143633 | CREO Stabilization System | 2015 |
| † | K124058 | Creo Stabilization System | 2013 |
| † | K191835 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | 2025 | 1 |
Has anything in its family been recalled? (9 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · Direct predicate · ◆ in the 2021 ancestors bar of FIG. 11 Class I recall
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 2 generations back · ◆ in the 2019 ancestors bar of FIG. 11 Class I recall
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · 2 generations back · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 3 generations back · ◆ in the 2018 ancestors bar of FIG. 11 Class I recall
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 3 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K151359ROSA BrainMedtech S.A · 2015 · 4 generations back · ◆ in the 2015 ancestors bar of FIG. 11 Class I recall
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 4 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 6 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 99 of the 704 ancestors have a recall of any class; 9 have a Class I recall.
- Of its descendants, K252327 (Icotec AG, 2025) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K161591.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The QUARTEX® Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C l-C7) and the thoracic spine (Tl-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the…
Read the full statement (307 words)
The QUARTEX® Occipito-Cervico-Thoracic Spinal System implants are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C l-C7) and the thoracic spine (Tl-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. These implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, rods may be connected to occipital cervical thoracic or thoracolumbar stabilization systems ranging in diameter from 3.2mm to 6.5mm, using corresponding connectors.
The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody spacers.
The ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.
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/K231850 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231850: QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231850
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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