510(k) · Cleared
ClearedMerete Locking Bone Plate System Iii
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 Nov 27, 2012 as substantially equivalent to K050457 (Merete Medical GmbH, 2005) and 5 other predicates after a 257-day review. Its family tree reaches back 7 generations to 1998. 12 later devices descend from it.
- Decided
- Nov 27, 2012
- Review
- 257 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K981372 (1998). 21 ancestors in all, the oldest K961522 (1996). 12 later devices descend from it, 2 citing it directly.
- 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 deviceK120787 Merete Locking Bone Plate System IiiMerete Medical GmbH · 2012
- Descendant · cites it directly · 10 of its ownK133691 Extrimilock Ankle Plating SystemOsteomed LP · 2014
- Descendant · 2 generations on · 5 of its ownK160191 Align Anterior Ankle Fusion PlateExtremity Medical, LLC · 2016
- Descendant · 2 generations on · 4 of its ownK181067 AlignX Ankle Fusion SystemExtremity Medical, LLC · 2018
- Descendant · 2 generations on · 2 of its ownK173121 Ankle Fusion Plating SystemIn2bones Sas · 2017
- Descendant · 3 generations on · 1 of its ownK231887 ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K133691Extrimilock Ankle Plating SystemOsteomed LP · 2014 · cites it directly10descendants
- K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC · 2016 · 2 generations on5descendants
- K181067AlignX Ankle Fusion SystemExtremity Medical, LLC · 2018 · 2 generations on4descendants
- K173121Ankle Fusion Plating SystemIn2bones Sas · 2017 · 2 generations on2descendants
- K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation · 2023 · 3 generations on1descendant
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) | K120787 | Merete Locking Bone Plate System Iii | Merete Medical GmbH | 2012 | — |
| +1 | K133691 | Extrimilock Ankle Plating System | Osteomed LP | 2014 | — |
| +2 | K160191 | Align Anterior Ankle Fusion Plate | Extremity Medical, LLC | 2016 | — |
| +2 | K181067 | AlignX Ankle Fusion System | Extremity Medical, LLC | 2018 | — |
| +2 | K173121 | Ankle Fusion Plating System | In2bones Sas | 2017 | — |
| +3 | K231887 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 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? (6)
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 |
|---|---|---|---|
| * | K050457 | Merete Metafix Small Fragment Bone Plate SystemSummary page 1…HW C HTY Regulatory Class: Class 11 Predicate Devices: * Merete MetaFixTM Small Fragment Locking Bone Plate System - K050457 * Merete Locking Bone Plate System - K090063 " Merete 3.0 and 3.5 mm Locking Screws - K081513 " Ascension Total Plate Sy… | 2005 |
| * | K090063 | Merete Locking Bone Plate SystemSummary page 1…ulatory Class: Class 11 Predicate Devices: * Merete MetaFixTM Small Fragment Locking Bone Plate System - K050457 * Merete Locking Bone Plate System - K090063 " Merete 3.0 and 3.5 mm Locking Screws - K081513 " Ascension Total Plate System - K1 00502 * SBI K-Wires - K051 605 *… | 2009 |
| * | K081513 | Merete 3.0 and 3.5 MM Locking ScrewsSummary page 1…ces: * Merete MetaFixTM Small Fragment Locking Bone Plate System - K050457 * Merete Locking Bone Plate System - K090063 " Merete 3.0 and 3.5 mm Locking Screws - K081513 " Ascension Total Plate System - K1 00502 * SBI K-Wires - K051 605 * Kirschner and Guide Wires - K1 00736 Device Descrip… | 2008 |
| * | K100502 | Ascension Total Plate SystemSummary page 1…cking Bone Plate System - K050457 * Merete Locking Bone Plate System - K090063 " Merete 3.0 and 3.5 mm Locking Screws - K081513 " Ascension Total Plate System - K1 00502 * SBI K-Wires - K051 605 * Kirschner and Guide Wires - K1 00736 Device Description: The Merete Locking Bone Plate System Il… | 2010 |
| * | K051605 | Sbi K-WiresSummary page 1…50457 * Merete Locking Bone Plate System - K090063 " Merete 3.0 and 3.5 mm Locking Screws - K081513 " Ascension Total Plate System - K1 00502 * SBI K-Wires - K051 605 * Kirschner and Guide Wires - K1 00736 Device Description: The Merete Locking Bone Plate System Ill consists of contoured, ana… | 2005 |
| * | K100736 | Kirschner and Guide WiresSummary page 1…m - K090063 " Merete 3.0 and 3.5 mm Locking Screws - K081513 " Ascension Total Plate System - K1 00502 * SBI K-Wires - K051 605 * Kirschner and Guide Wires - K1 00736 Device Description: The Merete Locking Bone Plate System Ill consists of contoured, anatomically shaped locking bone plates in va… | 2010 |
What descends from it? (12)
See all 122 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 14 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K133691 (Osteomed LP, 2014) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K050457.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 summary.
https://510kreport.com/device/K120787 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120787: Merete Locking Bone Plate System Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120787
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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