510(k) · Cleared
ClearedEUROPA Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MiRus, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 14, 2019 as substantially equivalent to K041119 (Depuy Spine, Inc., 2004) and 3 other predicates after a 400-day review. Its family tree reaches back 6 generations to 1995. 6 later devices descend from it.
- Decided
- Mar 14, 2019
- Review
- 400 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K950697 (1995). 31 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 5 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 4 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 3 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 2 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 1 generation backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- This deviceK180337 EUROPA Pedicle Screw SystemMiRus, LLC · 2019
- Descendant · cites it directly · 2 of its ownK242516 EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC · 2024
- Descendant · 2 generations on · 1 of its ownK252327 CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025
- Descendant · cites it directly · 1 of its ownK191757 EUROPA Pedicle Screw SystemMiRus, LLC · 2019
- Descendant · cites it directly · 0 of its ownK261284 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal…Alphatec Spine, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK254045 CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC · 2024 · cites it directly2descendants
- K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025 · 2 generations on1descendant
- K191757EUROPA Pedicle Screw SystemMiRus, LLC · 2019 · cites it directly1descendant
- K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026 · cites it directly0descendants
- K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −5 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −4 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −3 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −2 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −1 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| 0 (this device) | K180337 | EUROPA Pedicle Screw System | MiRus, LLC | 2019 | — |
| +1 | K242516 | EUROPA™ Posterior Cervical Fusion System | MiRus, LLC | 2024 | — |
| +2 | K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | 2025 | — |
| +1 | K191757 | EUROPA Pedicle Screw System | MiRus, LLC | 2019 | — |
| +1 | K261284 | Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation… | Alphatec Spine, Inc. | 2026 | — |
| +3 | 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 |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K041119 | Expedium Spine SystemSummary page 4…Submission Type Traditional 510(k) 9 35,0$5<PREDICATE EXPEDIUM® Spine System (K041119, K041801, K071495, K082942) VI. DEVICE DESCRIPTION The EUROPA™ Pedicle Screw System is a rigid thoracolumbosacral pedicle scr… | 2004 |
| * | K041801 | Expedium Mis Spine SystemSummary page 4…on Type Traditional 510(k) 9 35,0$5<PREDICATE EXPEDIUM® Spine System (K041119, K041801, K071495, K082942) VI. DEVICE DESCRIPTION The EUROPA™ Pedicle Screw System is a rigid thoracolumbosacral pedicle screw system… | 2004 |
| * | K071495 | Expedium 4.5MM Spine SystemSummary page 4…Traditional 510(k) 9 35,0$5<PREDICATE EXPEDIUM® Spine System (K041119, K041801, K071495, K082942) VI. DEVICE DESCRIPTION The EUROPA™ Pedicle Screw System is a rigid thoracolumbosacral pedicle screw system as def… | 2007 |
| * | K082942 | Modfication to: Expedium Spine SystemSummary page 4…Traditional 510(k) 9 35,0$5<PREDICATE EXPEDIUM® Spine System (K041119, K041801, K071495, K082942) VI. DEVICE DESCRIPTION The EUROPA™ Pedicle Screw System is a rigid thoracolumbosacral pedicle screw system as defined in 2… | 2008 |
What descends from it? (6)
4 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 24 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 31 ancestors have a recall of any class.
- Of its descendants, K242516 (MiRus, LLC, 2024) has gone furthest, with 2 descendants of its own.
- 28 other devices also cite its predicate K041119.
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 EUROPA™ Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The EUROPA™ Pedicle Screw System is intended for posterior, noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic…
Read the full statement (98 words)
The EUROPA™ Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
The EUROPA™ Pedicle Screw System is intended for posterior, noncervical pedicle fixation for the following indications: 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; pseudoarthrosis; and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180337: EUROPA Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180337
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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