510(k) · Cleared
ClearedMemometal Fixos Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Memometal Technologies · HWC Screw, Fixation, Bone
Cleared on Mar 21, 2007 as substantially equivalent to K962233 (Landos, Inc., 1996) and 1 other predicate after a 77-day review. Its family tree reaches back 2 generations to 1979. 84 later devices descend from it.
- Decided
- Mar 21, 2007
- Review
- 77 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K792022 (1979). 8 ancestors in all. 84 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 1 generation backK962236 Scarf Thread-Head ScrewLandos, Inc. · 1996
- This deviceK070039 Memometal Fixos ScrewsMemometal Technologies · 2007
- Descendant · cites it directly · 39 of its ownK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
- Descendant · cites it directly · 36 of its ownK142658 Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp · 2014 · Recalled
- Descendant · 2 generations on · 36 of its ownK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
- Descendant · cites it directly · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
- Descendant · 2 generations on · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · cites it directly39descendants
- K142658Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp · 2014 · cites it directly36descendants
- K123890Acumed Cannulated Screw SystemAcumed, LLC · 2013 · 2 generations on36descendants
- K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · cites it directly24descendants
- K190586Monster® Screw SystemParagon 28, Inc. · 2019 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −1 | K962236 | Scarf Thread-Head Screw | Landos, Inc. | 1996 | — |
| 0 (this device) | K070039 | Memometal Fixos Screws | Memometal Technologies | 2007 | — |
| +1 | K120493 | Mini Cannulated Headed and Headless Screw Set | Instratek, Inc. | 2012 | 1 |
| +1 | K142658 | Biomet Headless Compression and Twist-off Screws | Biomet Manufacturing Corp | 2014 | 2 |
| +2 | K123890 | Acumed Cannulated Screw System | Acumed, LLC | 2013 | 2 |
| +1 | K131722 | I.T.S. Extremity Fixation Systems | I.T.S. GmbH | 2013 | 2 |
| +2 | K190586 | Monster® Screw System | Paragon 28, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 6 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 13 | 0 |
| 2023 | 13 | 0 |
| 2024 | 11 | 0 |
| 2025 | 5 | 0 |
| 2026 | 10 | 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 |
|---|---|---|---|
| * | K962233 | Twist-Off ScrewSummary page 1…FIXOS Screws (S-Fix t C-Fix I P-Fix & W-Fix) Common Name FIXOS Screws Classification Name Screw, Fixation, Bone Legally marketed K962233 LANDOS twist-off screw (LANDOS acquired by predicate devices DEPUY Inc). K962236 LAN… | 1996 |
| * | K962236 | Scarf Thread-Head ScrewSummary page 1…, Fixation, Bone Legally marketed K962233 LANDOS twist-off screw (LANDOS acquired by predicate devices DEPUY Inc). K962236 LANDOS Scarf thread-head screw (LANDOS acquired by DEPUY Inc) Description… | 1996 |
| * | — | LANDOS Cannulated Bone Screw Named without a submission number | |
| * | — | Twist-Off Screw Named without a submission number |
What descends from it? (84)
See all 846 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120493 | Mini Cannulated Headed and Headless Screw Set | 2012 | 39 |
| K142658 | Biomet Headless Compression and Twist-off Screws | 2014 | 36 |
| K131722 | I.T.S. Extremity Fixation Systems | 2013 | 24 |
| K143229 | Nexis osteosynthesis compressive screws | 2015 | 3 |
| K143146 | Nexis osteosynthesis snap-off screws | 2015 | 2 |
| K211628 | MIS Precision Chevron Bunion System | 2022 | 1 |
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 28 years and passes through 3 companies; a new generation was cleared every 16.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K120493 (Instratek, Inc., 2012) has gone furthest, with 39 descendants of its own.
- 2 other devices also cite its predicate K962233.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-Fix) are indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070039 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070039: Memometal Fixos Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070039
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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