510(k) · Cleared
ClearedCMORE® CT System; CMORE® CT System Navigated Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icotec AG · NKG Posterior Cervical Screw System
Cleared on Nov 12, 2025 as substantially equivalent to K242516 (MiRus, LLC, 2024) and 2 other predicates after a 110-day review. Its family tree reaches back 22 generations to 2004. 10 of the 839 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Nov 12, 2025
- Review
- 110 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 22 generations to K040583 (2004). 837 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly. 10 of the 839 devices in this family, counting this one, have a Class I recall.
- Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations between
- 3 generations backK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- 2 generations backK200047 ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc. · 2020 · Recalled
- 1 generation backK231850 QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS®…Globus Medical, Inc. · 2024
- This deviceK252327 CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025
- Descendant · cites it directly · 0 of its ownK254045 CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2026
Show all 22 generations
- Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 21 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 20 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 19 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 18 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 17 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 15 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 14 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 13 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 12 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 11 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 10 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 9 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 8 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 7 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 6 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
- 5 generations backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
- 4 generations backK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- 3 generations backK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- 2 generations backK200047 ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc. · 2020 · Recalled
- 1 generation backK231850 QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS®…Globus Medical, Inc. · 2024
- This deviceK252327 CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −21 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −20 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −19 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −18 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −17 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −15 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −14 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −13 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −12 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −11 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −10 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −9 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −8 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −7 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −6 | K153203 | Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| −5 | K161591 | QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| −4 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| −3 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
| −2 | K200047 | ExcelsiusGPS Cranial 1.0 Module | Globus Medical, Inc. | 2020 | 3 |
| −1 | K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments | Globus Medical, Inc. | 2024 | — |
| 0 (this device) | K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | 2025 | — |
| +1 | 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 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 8 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 18 | 0 |
| 1996 | 19 | 0 |
| 1997 | 15 | 0 |
| 1998 | 24 | 0 |
| 1999 | 26 | 0 |
| 2000 | 31 | 0 |
| 2001 | 47 | 1 |
| 2002 | 40 | 0 |
| 2003 | 45 | 0 |
| 2004 | 67 | 0 |
| 2005 | 57 | 0 |
| 2006 | 40 | 0 |
| 2007 | 36 | 0 |
| 2008 | 69 | 0 |
| 2009 | 38 | 0 |
| 2010 | 40 | 2 |
| 2011 | 36 | 0 |
| 2012 | 18 | 0 |
| 2013 | 23 | 0 |
| 2014 | 16 | 0 |
| 2015 | 25 | 2 |
| 2016 | 9 | 1 |
| 2017 | 7 | 1 |
| 2018 | 5 | 1 |
| 2019 | 3 | 1 |
| 2020 | 5 | 0 |
| 2021 | 4 | 1 |
| 2024 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
10 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 K233989 CarboClear® Posterior Cervical Screw Systemscore 19.1 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K242516 | EUROPA™ Posterior Cervical Fusion SystemSummary page 5…0, Stereotaxic instrument Class: II Product Codes: NKG, OLO Primary Predicate: EUROPA™ Posterior Cervical Fusion System (K242516) Additional Predicate: CarboClear® Posterior Cervical Screw System (K233989) ExcelsiusHub™… | 2024 |
| * | K233989 | CarboClear® Posterior Cervical Screw SystemSummary page 5…NKG, OLO Primary Predicate: EUROPA™ Posterior Cervical Fusion System (K242516) Additional Predicate: CarboClear® Posterior Cervical Screw System (K233989) ExcelsiusHub™ (K231850) Reference Device: SYMPHONY™ OCT System (K181949) Indications F… | 2024 |
| * | K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsSummary page 5…sterior Cervical Fusion System (K242516) Additional Predicate: CarboClear® Posterior Cervical Screw System (K233989) ExcelsiusHub™ (K231850) Reference Device: SYMPHONY™ OCT System (K181949) Indications For Use: CMORE® CT System The CMORE® CT System is inte… | 2024 |
| † | K181949 | SYMPHONY™ OCT System | 2018 |
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 |
|---|---|---|---|
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw… | 2026 | 0 |
Has anything in its family been recalled? (10 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 · 2 generations back · ◆ in the 2021 ancestors bar of FIG. 11 Class I recall
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 3 generations back · ◆ in the 2019 ancestors bar of FIG. 11 Class I recall
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · 3 generations back · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 4 generations back · ◆ in the 2018 ancestors bar of FIG. 11 Class I recall
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 4 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K151359ROSA BrainMedtech S.A · 2015 · 5 generations back · ◆ in the 2015 ancestors bar of FIG. 11 Class I recall
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 5 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K093670Modification to: Oasys SystemStryker Spine · 2010 · 7 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 7 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 109 of the 837 ancestors have a recall of any class; 10 have a Class I recall.
- Of its descendants, K254045 (CarboFix Orthopedics, Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
CMORE® CT System The CMORE® CT System is 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 patients requiring adjuvant radiotherapy following spinal stabilization, metal markers at the screw tips can be used as fiducial markers in…
Read the full statement (340 words)
CMORE® CT System
The CMORE® CT System is 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 patients requiring adjuvant radiotherapy following spinal stabilization, metal markers at the screw tips can be used as fiducial markers in radiotherapy treatments (e.g., SBRT, proton therapy).
The CMORE® CT System is intended to provide immobilization and stabilization of spinal segments with anterior interbody support implanted at the same spinal level/s as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the upper thoracic spine (T1 to T3):
• Traumatic spinal fractures and/or traumatic dislocations
• Instability or deformity
• Failed previous fusions (e.g. pseudarthrosis)
• Degenerative disease, including intractable radiculopathy and/or myelopathy
• Neck and/or arm pain of discogenic origin as confirmed by radiographic studies
• Degenerative disease of the facets with instability
• Patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.
The CMORE® CT System is intended to be used with anterior interbody support implanted at the same spinal level/s with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The CMORE® CT System may be connected to the VADER® Pedicle System using connectors.
CMORE® CT System Navigated Instruments
CMORE® CT System Navigated Instruments are intended to be used during the preparation and placement of the CMORE® CT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with the Medtronic StealthStation® and Brainlab Navigation Systems which are indicated for any medical condition in which the use of stereotactic surgery may by appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT- or MR- based model, fluoroscopy images, or digitized landmarks of anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252327: CMORE® CT System; CMORE® CT System Navigated Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252327
Report an extraction error
Are you the manufacturer?
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