510(k) · Cleared
ClearedEuroscrew NG; Euroscrew TCP NG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teknimed · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on May 12, 2023 as substantially equivalent to K122228 (Sbm Sciences For Bio Materials, 2012) after an 87-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- May 12, 2023
- Review
- 87 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K994337 (2000). 8 ancestors in all, the oldest K002070 (2000). No later device cites it as a predicate yet.
- Root · 7 generations backK994337 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co. · 2000
- 6 generations backK021963 Biosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm) · 2003 · Recalled
- 5 generations backK050407 Ligafix Resorbable Interference Screw, Models 30 and 60Sciences For Bio Materials · 2005
- 4 generations backK061262 Ligafix Interference ScrewSciences For Bio Materials · 2006
- 3 generations backK070507 Modification to: Ligafix Interference ScrewScience For Biomaterials · 2007 · Recalled
- 2 generations backK090994 Ligafix Interface ScrewScience For Biomaterials · 2009
- 1 generation backK122228 Ligafix Interference ScrewSbm Sciences For Bio Materials · 2012
- This deviceK230394 Euroscrew NG; Euroscrew TCP NGTeknimed · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler | Orthovita Co. | 2000 | — |
| −6 | K021963 | Biosorb Resorbable Void Filler | Sciences ET Bio Materiaux (Sbm) | 2003 | 1 |
| −5 | K050407 | Ligafix Resorbable Interference Screw, Models 30 and 60 | Sciences For Bio Materials | 2005 | — |
| −4 | K061262 | Ligafix Interference Screw | Sciences For Bio Materials | 2006 | — |
| −3 | K070507 | Modification to: Ligafix Interference Screw | Science For Biomaterials | 2007 | 1 |
| −2 | K090994 | Ligafix Interface Screw | Science For Biomaterials | 2009 | — |
| −1 | K122228 | Ligafix Interference Screw | Sbm Sciences For Bio Materials | 2012 | — |
| 0 (this device) | K230394 | Euroscrew NG; Euroscrew TCP NG | Teknimed | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K122228 | Ligafix Interference ScrewSummary page 4…multiple component metallic bone Fixation appliances and accessories Predicate Device: LIGAFIX Interference Screw (K122228) Device Description Teknimed’s EUROSCREW® NG and EUROSCREW® TCP NG are bioabsorbable interference screws used in ligament su… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 8 ancestors have a recall of any class.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
EUROSCREW® NG and EUROSCREW® NG TCP screws are indicated in knee anterior cruciate ligament reconstruction in ligamentoplasty procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230394: Euroscrew NG; Euroscrew TCP NG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230394
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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