510(k) · Cleared
ClearedMerete Metafix Small Fragment Bone Plate System
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 Mar 14, 2005 as substantially equivalent to K000684 (Synthes (Usa), 2000) and 1 other predicate after a 19-day review. Its family tree reaches back 3 generations to 1998. 258 later devices descend from it.
- Decided
- Mar 14, 2005
- Review
- 19 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K981372 (1998). 9 ancestors in all. 258 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 2 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 1 generation backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- This deviceK050457 Merete Metafix Small Fragment Bone Plate SystemMerete Medical GmbH · 2005
- Descendant · cites it directly · 257 of its ownK063487 Merete BLP Small Fragment Locking Bone PlateMerete Medical GmbH · 2007
- Descendant · cites it directly · 256 of its ownK081513 Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH · 2008
- Descendant · 2 generations on · 241 of its ownK090063 Merete Locking Bone Plate SystemMerete Medical, Inc. · 2009
- Descendant · 3 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- Descendant · 4 generations on · 118 of its ownK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
Showing 5 of 258 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 258 · See all- K063487Merete BLP Small Fragment Locking Bone PlateMerete Medical GmbH · 2007 · cites it directly257descendants
- K081513Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH · 2008 · cites it directly256descendants
- K090063Merete Locking Bone Plate SystemMerete Medical, Inc. · 2009 · 2 generations on241descendants
- K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 3 generations on228descendants
- K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011 · 4 generations on118descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −2 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −1 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| 0 (this device) | 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 | — |
| +1 | K081513 | Merete 3.0 and 3.5 MM Locking Screws | Merete Medical GmbH | 2008 | — |
| +2 | K090063 | Merete Locking Bone Plate System | Merete Medical, Inc. | 2009 | — |
| +3 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| +4 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 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 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? (2)
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…TT Proposed Regulatory Class: Class II Predicate Device: ' Synthes Small Fragment Locking Compression Plate (LCP) K000684 *Smith & Nephew Locking Bone Plate System K033669 Description… | 2000 |
| * | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Summary page 1…pression Plate (LCP) K000684 *Smith & Nephew Locking Bone Plate System K033669 Description of Device: The Merete MetaFix Small Fragment Locking Plate System consist… | 2003 |
What descends from it? (258)
See all 2584 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 7 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K063487 (Merete Medical GmbH, 2007) has gone furthest, with 257 descendants of its own.
- 68 other devices also cite its predicate K000684.
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.
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 MetaFix Small Fragment Locking Bone Plate System is used 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, ulnar, fibula, metacarpals, 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/K050457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050457: Merete Metafix Small Fragment 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/K050457
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