510(k) · Cleared
ClearedTwist-Off (TM) 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 deviceK971069 Twist-Off (TM) ScrewLandos, Inc. · 1997
- Descendant · cites it directly · 36 of its ownK142658 Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp · 2014 · Recalled
- Descendant · 2 generations on · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- Descendant · cites it directly · 20 of its ownK023365 Leforte System Bone ScrewJeil Medical Corporation · 2003
- Descendant · 3 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- Descendant · 2 generations on · 9 of its ownK131311 Arix Foot SystemJeil Medical Corporation · 2013
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K142658Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp · 2014 · cites it directly36descendants
- K190586Monster® Screw SystemParagon 28, Inc. · 2019 · 2 generations on21descendants
- K023365Leforte System Bone ScrewJeil Medical Corporation · 2003 · cites it directly20descendants
- K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 3 generations on9descendants
- K131311Arix Foot SystemJeil Medical Corporation · 2013 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971069 | Twist-Off (TM) Screw | Landos, Inc. | 1997 | — |
| +1 | K142658 | Biomet Headless Compression and Twist-off Screws | Biomet Manufacturing Corp | 2014 | 2 |
| +2 | K190586 | Monster® Screw System | Paragon 28, Inc. | 2019 | — |
| +1 | K023365 | Leforte System Bone Screw | Jeil Medical Corporation | 2003 | — |
| +3 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
| +2 | K131311 | Arix Foot System | Jeil Medical Corporation | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 10 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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? (4)
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 Twist-off Screw Named without a submission number | |
| * | — | Howmedica Luhr Screw System Named without a submission number | |
| * | — | Synthes Cortex Screw Named without a submission number | |
| * | — | Osteomed 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, K142658 (Biomet Manufacturing Corp, 2014) has gone furthest, with 36 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/K971069 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971069: Twist-Off (TM) Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971069
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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