510(k) · Cleared
ClearedMerete 3.0 and 3.5 MM Locking Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merete Medical GmbH · HWC Screw, Fixation, Bone
Cleared on Jul 18, 2008 as substantially equivalent to K000684 (Synthes (Usa), 2000) and 4 other predicates after a 49-day review. Its family tree reaches back 5 generations to 1998. 256 later devices descend from it.
- Decided
- Jul 18, 2008
- Review
- 49 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K981372 (1998). 13 ancestors in all. 256 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 4 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 3 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 2 generations backK050457 Merete Metafix Small Fragment Bone Plate SystemMerete Medical GmbH · 2005
- 1 generation backK063487 Merete BLP Small Fragment Locking Bone PlateMerete Medical GmbH · 2007
- This deviceK081513 Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH · 2008
- Descendant · cites it directly · 241 of its ownK090063 Merete Locking Bone Plate SystemMerete Medical, Inc. · 2009
- Descendant · 2 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- Descendant · 3 generations on · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- Descendant · 3 generations on · 76 of its ownK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- Descendant · 3 generations on · 53 of its ownK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
Showing 5 of 256 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 256 · See all- K090063Merete Locking Bone Plate SystemMerete Medical, Inc. · 2009 · cites it directly241descendants
- K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 2 generations on228descendants
- K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · 3 generations on118descendants
- K120070Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · 3 generations on76descendants
- K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA · 2012 · 3 generations on53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −4 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −3 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −2 | K050457 | Merete Metafix Small Fragment Bone Plate System | Merete Medical GmbH | 2005 | — |
| −1 | K063487 | Merete BLP Small Fragment Locking Bone Plate | Merete Medical GmbH | 2007 | — |
| 0 (this device) | K081513 | Merete 3.0 and 3.5 MM Locking Screws | Merete Medical GmbH | 2008 | — |
| +1 | K090063 | Merete Locking Bone Plate System | Merete Medical, Inc. | 2009 | — |
| +2 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| +3 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| +3 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| +3 | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal… | Synthes USA | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 18 | 0 |
| 2016 | 8 | 0 |
| 2017 | 19 | 0 |
| 2018 | 9 | 0 |
| 2019 | 12 | 0 |
| 2020 | 18 | 0 |
| 2021 | 22 | 0 |
| 2022 | 18 | 0 |
| 2023 | 21 | 0 |
| 2024 | 32 | 0 |
| 2025 | 20 | 0 |
| 2026 | 33 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 1…Product Code: HWC Proposed Regulatory Class: Class II Predicate Device: - Synthes Small Fragment Locking Compression Plate (LCP) - K000684 - Smith & Nephew Locking Bone Plate System - K033669 - DARCO Locking Bone Plate System - K061808 - Merete MetaFix Small… | 2000 |
| * | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Summary page 1…latory Class: Class II Predicate Device: - Synthes Small Fragment Locking Compression Plate (LCP) - K000684 - Smith & Nephew Locking Bone Plate System - K033669 - DARCO Locking Bone Plate System - K061808 - Merete MetaFix Small Fragment Locking Bone Plate System - K050457 - Mer… | 2003 |
| * | K061808 | Darco Locking Bone Plate SystemSummary page 1…ce: - Synthes Small Fragment Locking Compression Plate (LCP) - K000684 - Smith & Nephew Locking Bone Plate System - K033669 - DARCO Locking Bone Plate System - K061808 - Merete MetaFix Small Fragment Locking Bone Plate System - K050457 - Merete BLP Small Fragment locking Bone Plate System… | 2006 |
| * | K050457 | Merete Metafix Small Fragment Bone Plate SystemSummary page 1…84 - Smith & Nephew Locking Bone Plate System - K033669 - DARCO Locking Bone Plate System - K061808 - Merete MetaFix Small Fragment Locking Bone Plate System - K050457 - Merete BLP Small Fragment locking Bone Plate System - K063487 Device Description: The screws are fully threaded and self-t… | 2005 |
| * | K063487 | Merete BLP Small Fragment Locking Bone PlateSummary page 1…O Locking Bone Plate System - K061808 - Merete MetaFix Small Fragment Locking Bone Plate System - K050457 - Merete BLP Small Fragment locking Bone Plate System - K063487 Device Description: The screws are fully threaded and self-tapping with a threaded head to lock into Merete Locking plates. Lock… | 2007 |
What descends from it? (256)
See all 2565 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090063 | Merete Locking Bone Plate System | 2009 | 241 |
| K100721 | Locking Bone Screw Model HCQ04, HCZ04 | 2010 | 13 |
| K120787 | Merete Locking Bone Plate System Iii | 2012 | 12 |
| K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete… | 2016 | 0 |
| K102688 | Merete Locking Bone Plate System II | 2010 | 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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K090063 (Merete Medical, Inc., 2009) has gone furthest, with 241 descendants of its own.
- 68 other devices also cite its predicate K000684.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Merete 3.0 mm and 3.5 mm Locking Screws are intended to be used in combination with Merete Locking plates for adult and pediatric patients as indicated for small bone fracture fixation. Indications for use include fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulner, fibula, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081513: Merete 3.0 and 3.5 MM Locking Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081513
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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