510(k) · Cleared
ClearedMerete Locking Bone Plate System II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merete Medical GmbH · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Dec 3, 2010 as substantially equivalent to K090063 (Merete Medical, Inc., 2009) and 4 other predicates after a 77-day review. Its family tree reaches back 7 generations to 1998.
- Decided
- Dec 3, 2010
- Review
- 77 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K981372 (1998). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 6 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 5 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 4 generations backK050457 Merete Metafix Small Fragment Bone Plate SystemMerete Medical GmbH · 2005
- 3 generations backK063487 Merete BLP Small Fragment Locking Bone PlateMerete Medical GmbH · 2007
- 2 generations backK081513 Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH · 2008
- 1 generation backK090063 Merete Locking Bone Plate SystemMerete Medical, Inc. · 2009
- This deviceK102688 Merete Locking Bone Plate System IIMerete Medical GmbH · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −6 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −5 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −4 | K050457 | Merete Metafix Small Fragment Bone Plate System | Merete Medical GmbH | 2005 | — |
| −3 | K063487 | Merete BLP Small Fragment Locking Bone Plate | Merete Medical GmbH | 2007 | — |
| −2 | 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 | — |
| 0 (this device) | K102688 | Merete Locking Bone Plate System II | Merete Medical GmbH | 2010 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K090063 | Merete Locking Bone Plate SystemSummary page 1…liances and accessories Product Code: KTT Proposed Regulatory Class: Class 11 Predicate Device: - Merete Locking Bone Plate System - K090063 - Merete MetaFix Small Fragment Bone Plate - K050457 - Merete BLPTM Small Fragment Locking Bone Plate System - K063487… | 2009 |
| * | K050457 | Merete Metafix Small Fragment Bone Plate SystemSummary page 1…KTT Proposed Regulatory Class: Class 11 Predicate Device: - Merete Locking Bone Plate System - K090063 - Merete MetaFix Small Fragment Bone Plate - K050457 - Merete BLPTM Small Fragment Locking Bone Plate System - K063487 - Merete 3.0 mm and 3.5 mm Locking Screws - K081513 -… | 2005 |
| * | K063487 | Merete BLP Small Fragment Locking Bone PlateSummary page 1…: - Merete Locking Bone Plate System - K090063 - Merete MetaFix Small Fragment Bone Plate - K050457 - Merete BLPTM Small Fragment Locking Bone Plate System - K063487 - Merete 3.0 mm and 3.5 mm Locking Screws - K081513 - DARCO Locking Plate System - K061 808 Device Description: The Mere… | 2007 |
| * | K081513 | Merete 3.0 and 3.5 MM Locking ScrewsSummary page 1…Merete MetaFix Small Fragment Bone Plate - K050457 - Merete BLPTM Small Fragment Locking Bone Plate System - K063487 - Merete 3.0 mm and 3.5 mm Locking Screws - K081513 - DARCO Locking Plate System - K061 808 Device Description: The Merete Locking Bone Plate System 11consists of contoured, an… | 2008 |
| * | K061808 | Darco Locking Bone Plate SystemSummary page 1…K050457 - Merete BLPTM Small Fragment Locking Bone Plate System - K063487 - Merete 3.0 mm and 3.5 mm Locking Screws - K081513 - DARCO Locking Plate System - K061 808 Device Description: The Merete Locking Bone Plate System 11consists of contoured, anatomically shaped locking bone plates in var… | 2006 |
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 12 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 15 ancestors have a recall of any class.
- 2 other devices also cite its predicate K090063.
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. 2010, 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/K102688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102688: Merete Locking Bone Plate System II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102688
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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