510(k) · Cleared
ClearedMerete Twistcut Snap-Off 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 Jul 7, 2005 as substantially equivalent to K971069 (Landos, Inc., 1997) and 1 other predicate after a 48-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- Jul 7, 2005
- Review
- 48 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K924138 (1993). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK924138 Osteomed M3 System (SBF System)Osteomed Corp. · 1993
- 2 generations backK962233 Twist-Off ScrewLandos, Inc. · 1996
- 1 generation backK011946 The Spin Snap-Off ScrewNew Deal, S.A. · 2001
- This deviceK051323 Merete Twistcut Snap-Off Bone ScrewMerete Medical GmbH · 2005
- Descendant · cites it directly · 0 of its ownK170012 Foot and Hand MotionNewclip Technics · 2017
- 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924138 | Osteomed M3 System (SBF System) | Osteomed Corp. | 1993 | — |
| −2 | K962233 | Twist-Off Screw | Landos, Inc. | 1996 | — |
| −1 | K011946 | The Spin Snap-Off Screw | New Deal, S.A. | 2001 | — |
| 0 (this device) | K051323 | Merete Twistcut Snap-Off Bone Screw | Merete Medical GmbH | 2005 | — |
| +1 | K170012 | Foot and Hand Motion | Newclip Technics | 2017 | — |
| +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 |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K971069 | Twist-Off (TM) ScrewSummary page 1…threaded Metallic bone fixation fastener Proposed Regulatory Class: Class II Product Code: HWC Predicate Devices: Landos TWIST-OFF' Screw (K971069) New Deal SPIN® SNAP-OFF Screw (K011946) Description of Device: The Merete TwistCutM Snap… | 1997 |
| * | K011946 | The Spin Snap-Off ScrewSummary page 1…ass II Product Code: HWC Predicate Devices: Landos TWIST-OFF' Screw (K971069) New Deal SPIN® SNAP-OFF Screw (K011946) Description of Device: The Merete TwistCutM Snap-Off Bone Screw is made of Titanium allo… | 2001 |
What descends from it? (2)
2 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 12 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K170012 (Newclip Technics, 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K971069.
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?
The Merete TwistCut Tm Snap-Off Bone Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: Fixation of Small Bone Fragments, Weil-Osteotomy, Mono-Cortical Fixation, Osteotomies and fractures fixation in the foot and hand.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051323: Merete Twistcut Snap-Off Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051323
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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