510(k) · Cleared
ClearedMerete Compression Screws
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 Sep 2, 2009 as substantially equivalent to K050346 (New Deal, S.A., 2005) and 1 other predicate after a 77-day review. Its family tree reaches back 4 generations to 1996. 26 later devices descend from it.
- Decided
- Sep 2, 2009
- Review
- 77 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K962823 (1996). 10 ancestors in all. 26 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 3 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 2 generations backK011821 Modification to the I.C.O.S ScrewNew Deal, S.A. · 2001
- 1 generation backK050346 Stabilization ScrewNew Deal, S.A. · 2005 · Recalled
- This deviceK091798 Merete Compression ScrewsMerete Medical GmbH · 2009
- Descendant · cites it directly · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
- Descendant · 2 generations on · 11 of its ownK172617 Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc. · 2017
- Descendant · 3 generations on · 7 of its ownK213036 Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc. · 2021
- Descendant · 4 generations on · 4 of its ownK240173 Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · Recalled
- Descendant · 5 generations on · 3 of its ownK242415 TMC Compression Implant SystemTreace Medical Concepts · 2024
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · cites it directly24descendants
- K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc. · 2017 · 2 generations on11descendants
- K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc. · 2021 · 3 generations on7descendants
- K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc. · 2024 · 4 generations on4descendants
- K242415TMC Compression Implant SystemTreace Medical Concepts · 2024 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −3 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −2 | K011821 | Modification to the I.C.O.S Screw | New Deal, S.A. | 2001 | — |
| −1 | K050346 | Stabilization Screw | New Deal, S.A. | 2005 | 4 |
| 0 (this device) | K091798 | Merete Compression Screws | Merete Medical GmbH | 2009 | — |
| +1 | K131722 | I.T.S. Extremity Fixation Systems | I.T.S. GmbH | 2013 | 2 |
| +2 | K172617 | Treace Medical Concepts (TMC) Compression Screw System | Treace Medical Concepts, Inc. | 2017 | — |
| +3 | K213036 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2021 | — |
| +4 | K240173 | Treace Medical Systems (TMC) Plating System | Treace Medical Concepts, Inc. | 2024 | 1 |
| +5 | K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K050346 | Stabilization ScrewSummary page 1…fragments in long bones or small bone fractures. The size of the chosen screw should be adapted to the specific indication. Predicate Device: Screws 3.0 mm and 4.3 mm: K050346 NewDeal Stabilization Screw Screw 6.5 mm: K991 151 Vilex/Duval/Orthex Cannulated Bone Screw Substancial Equivalence: Merete Comp… | 2005 |
| * | K991151 | Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone ScrewSummary page 1…The size of the chosen screw should be adapted to the specific indication. Predicate Device: Screws 3.0 mm and 4.3 mm: K050346 NewDeal Stabilization Screw Screw 6.5 mm: K991 151 Vilex/Duval/Orthex Cannulated Bone Screw Substancial Equivalence: Merete Compression Screws are similar to legally marketed pred… | 1999 |
What descends from it? (26)
See all 262 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 13 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K131722 (I.T.S. GmbH, 2013) has gone furthest, with 24 descendants of its own.
- 4 other devices also cite its predicate K050346.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
Merete Compression Screws are indicated for fracture fixation and reconstruction of
various bones, including
- osteotomies in the foot (as Hallux Valgus treatment) or hand,
- arthrodesis in hand, foot or ankle surgery,
- fixation of bone fragments in long bones or small bone fractures.
The size of the chosen screw should be adapted to the specific indication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091798 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091798: Merete Compression Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091798
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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