510(k) · Cleared
ClearedLocking Bone Plate Style 14, Metafix Locking Screw 3.8, Merete Cannulated PCS 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merete Medical GmbH · HRS Plate, Fixation, Bone
Cleared on Apr 7, 2014 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Apr 7, 2014
- Review
- 84 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK140069 Locking Bone Plate Style 14, Metafix Locking Screw 3.8, Merete…Merete Medical GmbH · 2014
- Descendant · cites it directly · 0 of its ownK152187 MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical…Merete Medical GmbH · 2016
Most influential descendants
Showing 1 of 1 · See all- K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K140069 | Locking Bone Plate Style 14, Metafix Locking Screw 3.8, Merete Cannulated PCS… | Merete Medical GmbH | 2014 | — |
| +1 | K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws… | Merete Medical GmbH | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete… | 2016 | 0 |
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?
- Of its descendants, K152187 (Merete Medical GmbH, 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Merete Locking Bone Plate System can be used for adult and pediatric patients.
Indications for use include fixation of fresh fractures, revision procedures, joint fusion,
and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K140069 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140069: Locking Bone Plate Style 14, Metafix Locking Screw 3.8, Merete Cannulated PCS 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140069
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