510(k) · Cleared
ClearedMerete Locking Bone Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merete Medical, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Apr 22, 2009 as substantially equivalent to K061808 (Darco International, Inc., 2006) and 2 other predicates after a 103-day review. Its family tree reaches back 6 generations to 1998. 241 later devices descend from it.
- Decided
- Apr 22, 2009
- Review
- 103 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K981372 (1998). 14 ancestors in all. 241 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 5 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 4 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK050457 Merete Metafix Small Fragment Bone Plate SystemMerete Medical GmbH · 2005
- 2 generations backK063487 Merete BLP Small Fragment Locking Bone PlateMerete Medical GmbH · 2007
- 1 generation backK081513 Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH · 2008
- This deviceK090063 Merete Locking Bone Plate SystemMerete Medical, Inc. · 2009
- Descendant · cites it directly · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- Descendant · 2 generations on · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- Descendant · 2 generations on · 76 of its ownK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- Descendant · 2 generations on · 53 of its ownK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- Descendant · 2 generations on · 44 of its ownK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
Showing 5 of 241 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 241 · See all- K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · cites it directly228descendants
- K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · 2 generations on118descendants
- K120070Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · 2 generations on76descendants
- K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA · 2012 · 2 generations on53descendants
- K120854Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012 · 2 generations on44descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −5 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −4 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −3 | K050457 | Merete Metafix Small Fragment Bone Plate System | Merete Medical GmbH | 2005 | — |
| −2 | K063487 | Merete BLP Small Fragment Locking Bone Plate | Merete Medical GmbH | 2007 | — |
| −1 | K081513 | Merete 3.0 and 3.5 MM Locking Screws | Merete Medical GmbH | 2008 | — |
| 0 (this device) | K090063 | Merete Locking Bone Plate System | Merete Medical, Inc. | 2009 | — |
| +1 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| +2 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| +2 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| +2 | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal… | Synthes USA | 2012 | — |
| +2 | K120854 | Synthes VA LCP Ankle Trauma System | 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 |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 15 | 0 |
| 2016 | 7 | 0 |
| 2017 | 18 | 0 |
| 2018 | 9 | 0 |
| 2019 | 12 | 0 |
| 2020 | 17 | 0 |
| 2021 | 22 | 0 |
| 2022 | 18 | 0 |
| 2023 | 21 | 0 |
| 2024 | 32 | 0 |
| 2025 | 19 | 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.3 · 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? (3)
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 |
|---|---|---|---|
| * | K061808 | Darco Locking Bone Plate System Our reading of the summary gave K067808, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DARCO Locking Plate System”. | 2006 |
| * | K063487 | Merete BLP Small Fragment Locking Bone PlateSummary page 1…Proposed Regulatory Class: Class 11 Predicate Device: - DARCO Locking Plate System - K067808 - Merete BLPTM Small Fragment Locking Bone Plate System - K063487 - Merete 3.0 mm and 3.5 mm Locking Screws - K081513 Device Description: The Merete Locking Bone Plate System consists of con… | 2007 |
| * | K081513 | Merete 3.0 and 3.5 MM Locking ScrewsSummary page 1…Device: - DARCO Locking Plate System - K067808 - Merete BLPTM Small Fragment Locking Bone Plate System - K063487 - Merete 3.0 mm and 3.5 mm Locking Screws - K081513 Device Description: The Merete Locking Bone Plate System consists of contoured, anatomically shaped locking bone plates in vario… | 2008 |
What descends from it? (241)
See all 2413 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 11 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 14 ancestors have a recall of any class.
- Of its descendants, K100776 (Synthes (Usa), 2010) has gone furthest, with 228 descendants of its own.
- 23 other devices also cite its predicate K061808.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
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 summary.
https://510kreport.com/device/K090063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090063: Merete Locking Bone Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090063
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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