510(k) · Cleared
ClearedScarf Thread-Head (TM) Head Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Landos, Inc. · HWC Screw, Fixation, Bone
Cleared on Jul 9, 1997 after a 107-day review. The FDA summary names its predicate without a number. 61 later devices descend from it.
- Decided
- Jul 9, 1997
- Review
- 107 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
61 later devices descend from it, 3 citing it directly.
- This deviceK971070 Scarf Thread-Head (TM) Head ScrewLandos, Inc. · 1997
- Descendant · cites it directly · 55 of its ownK050346 Stabilization ScrewNew Deal, S.A. · 2005 · Recalled
- Descendant · 2 generations on · 52 of its ownK071639 Qwix Positioning ScrewNewdeal Sas · 2007 · Recalled
- Descendant · 2 generations on · 26 of its ownK091798 Merete Compression ScrewsMerete Medical GmbH · 2009
- Descendant · 3 generations on · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
- Descendant · 2 generations on · 18 of its ownK131920 Stabilization ScrewIn2bones Sas · 2014 · Recalled
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K050346Stabilization ScrewNew Deal, S.A. · 2005 · cites it directly55descendants
- K071639Qwix Positioning ScrewNewdeal Sas · 2007 · 2 generations on52descendants
- K091798Merete Compression ScrewsMerete Medical GmbH · 2009 · 2 generations on26descendants
- K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · 3 generations on24descendants
- K131920Stabilization ScrewIn2bones Sas · 2014 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971070 | Scarf Thread-Head (TM) Head Screw | Landos, Inc. | 1997 | — |
| +1 | K050346 | Stabilization Screw | New Deal, S.A. | 2005 | 4 |
| +2 | K071639 | Qwix Positioning Screw | Newdeal Sas | 2007 | 1 |
| +2 | K091798 | Merete Compression Screws | Merete Medical GmbH | 2009 | — |
| +3 | K131722 | I.T.S. Extremity Fixation Systems | I.T.S. GmbH | 2013 | 2 |
| +2 | K131920 | Stabilization Screw | In2bones Sas | 2014 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 7 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 9 | 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? (3)
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 |
|---|---|---|---|
| * | — | Landos SCARF Thread-Head Screw Named without a submission number | |
| * | — | Zimmer Herbert-Whipple Bone Screw Named without a submission number | |
| * | — | Ostcomed M3 Screw Named without a submission number |
What descends from it? (61)
See all 613 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?
- Of its descendants, K050346 (New Deal, S.A., 2005) has gone furthest, with 55 descendants of its own.
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?
Fixation of fracture, fusion of a joint or bone reconstruction (osteotomy) of the phalanges, metacarpals and carpals of the hand.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971070 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971070: Scarf Thread-Head (TM) Head Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971070
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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