510(k) · Cleared
ClearedEUROPA™ Posterior Cervical Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MiRus, LLC · NKG Posterior Cervical Screw System
Cleared on Nov 19, 2024 as substantially equivalent to K182508 (Nexxt Spine, LLC, 2018) and 1 other predicate after an 88-day review. Its family tree reaches back 17 generations to 1985. 2 later devices descend from it.
- Decided
- Nov 19, 2024
- Review
- 88 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K853033 (1985). 206 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations between
- 3 generations backK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
- 2 generations backK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
- 1 generation backK182508 Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC · 2018
- This deviceK242516 EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC · 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 17 generations
- Root · 17 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 16 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 15 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 14 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 13 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 12 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 11 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 10 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 9 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 8 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 7 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 6 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 5 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 4 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 3 generations backK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
- 2 generations backK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
- 1 generation backK182508 Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC · 2018
- This deviceK242516 EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC · 2024
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 |
|---|---|---|---|---|---|
| −17 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −16 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −15 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −14 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −13 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −12 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −11 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −10 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −9 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −8 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −7 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −6 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −5 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −4 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| −3 | K123783 | Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants | Globus Medical, Inc. | 2013 | — |
| −2 | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | Globus Medical, Inc. | 2015 | 1 |
| −1 | K182508 | Saxxony™ Posterior Cervical Thoracic System | Nexxt Spine, LLC | 2018 | — |
| 0 (this device) | K242516 | EUROPA™ Posterior Cervical Fusion System | MiRus, LLC | 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 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 9 | 0 |
| 2003 | 11 | 0 |
| 2004 | 28 | 0 |
| 2005 | 22 | 0 |
| 2006 | 9 | 0 |
| 2007 | 8 | 0 |
| 2008 | 14 | 0 |
| 2009 | 12 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
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.
Planning a device in NKG? 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? (2)
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.
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? (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 39 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 17 of the 206 ancestors have a recall of any class.
- Of its descendants, K252327 (Icotec AG, 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K182508.
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 EUROPA™ Posterior Cervical Fusion System is intended to provide immobilization and stabilization of spinal segments 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) * Tumors involving the cervical/thoracic spine *…
Read the full statement (175 words)
The EUROPA™ Posterior Cervical Fusion System is intended to provide immobilization and stabilization of spinal segments 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)
* Tumors involving the cervical/thoracic spine
* 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
The EUROPA™ Posterior Cervical Fusion System is 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, the EUROPA™ Posterior Cervical Fusion System may be connected to the EUROPA™ Pedicle Screw System via the rod to rod connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242516 · printed Nov 3, 2026
Cite this page
510(k) Report. “K242516: EUROPA™ Posterior Cervical Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K242516
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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