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 Jan 22, 2019 as substantially equivalent to K082942 (Depuy Spine, Inc., 2008) and 3 other predicates after an 88-day review. Its family tree reaches back 6 generations to 1995. 2 later devices descend from it.
- Decided
- Jan 22, 2019
- Review
- 88 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. 2 later devices descend from it, 2 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 deviceK182970 EUROPA™ Pedicle Screw SystemMiRus, LLC · 2019
- Descendant · cites it directly · 1 of its ownK191757 EUROPA Pedicle Screw SystemMiRus, LLC · 2019
- Descendant · cites it directly · 0 of its ownK192268 Europa Pedicle Screw SystemMiRus, LLC · 2019
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 |
|---|---|---|---|---|---|
| −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) | K182970 | EUROPA™ Pedicle Screw System | MiRus, LLC | 2019 | — |
| +1 | K191757 | EUROPA Pedicle Screw System | MiRus, LLC | 2019 | — |
| +1 | K192268 | Europa Pedicle Screw System | MiRus, LLC | 2019 | — |
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 |
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 |
|---|---|---|---|
| * | K082942 | Modfication to: Expedium Spine SystemSummary page 4…e Traditional 510(k) V. PREDICATE DEVICE Primary Predicate EXPEDIUM® Spine System - K082942 Additional Predicates EXPEDIUM® Spine System -… | 2008 |
| * | K041801 | Expedium Mis Spine SystemSummary page 4…EXPEDIUM® Spine System - K082942 Additional Predicates EXPEDIUM® Spine System - K041801 EXPEDIUM® Spine System - K071495 EXPEDIUM® Spin… | 2004 |
| * | K071495 | Expedium 4.5MM Spine SystemSummary page 4…Additional Predicates EXPEDIUM® Spine System - K041801 EXPEDIUM® Spine System - K071495 EXPEDIUM® Spine System - K041119 VI. DEVICE DESCRIPTION The EUROPA™ Pedicle Screw System… | 2007 |
| * | K041119 | Expedium Spine SystemSummary page 4…EDIUM® Spine System - K041801 EXPEDIUM® Spine System - K071495 EXPEDIUM® Spine System - K041119 VI. DEVICE DESCRIPTION The EUROPA™ Pedicle Screw System is a rigid thoracolumbosacral pedicle screw system as defined in 21 CFR 8… | 2004 |
What descends from it? (2)
2 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, K191757 (MiRus, LLC, 2019) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K082942.
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/K182970 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182970: 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/K182970
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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