510(k) · Cleared
ClearedMerete Duothreadtm Bone Screw
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 May 27, 2005 as substantially equivalent to K971070 (Landos, Inc., 1997) and 1 other predicate after a 44-day review. Its family tree reaches back 1 generation to 1979. 1 later device descends from it.
- Decided
- May 27, 2005
- Review
- 44 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K792022 (1979). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- This deviceK050924 Merete Duothreadtm Bone ScrewMerete Medical GmbH · 2005
- Descendant · cites it directly · 0 of its ownK152187 MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical…Merete Medical GmbH · 2016
Most influential descendants
Showing 1 of 1 · See all- K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| 0 (this device) | K050924 | Merete Duothreadtm Bone Screw | Merete Medical GmbH | 2005 | — |
| +1 | K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws… | Merete Medical GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 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? (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 |
|---|---|---|---|
| * | K971070 | Scarf Thread-Head (TM) Head ScrewSummary page 1…e fixation fastener Proposed Regulatory Class: Class It Product Code: IIWC Predicate Devices: Landos Scarf Thread-IteadTM }lead Screw(K971070) Zimmer Herbert Bone Screw (K792022) 1)escription of Device: The DuoThreadf m Bone screw i… | 1997 |
| * | K792022 | Herbert Bone ScrewSummary page 1…ct Code: IIWC Predicate Devices: Landos Scarf Thread-IteadTM }lead Screw(K971070) Zimmer Herbert Bone Screw (K792022) 1)escription of Device: The DuoThreadf m Bone screw is a fully or partially threaded cain… | 1979 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete… | 2016 | 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?
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Small bone fracture fixation. Fixation and stabilization of bones of the feet in case of a osteotomy or fusion, such as Scarf-Osteotomy, Chevron-Austin Osteotomy, Akin-Osteotomy, Closing wedge osteotomy, MPG-Arthrodesis as well as for the fixation of almost all common osteotomies of the first metatarsal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050924 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050924: Merete Duothreadtm Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050924
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