510(k) · Cleared
ClearedSuper Screw 3.5 MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed Corp. · HWC Screw, Fixation, Bone
Cleared on Dec 8, 1995 after an 84-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 465 devices in its family, counting itself, has a Class I recall. 464 later devices descend from it.
- Decided
- Dec 8, 1995
- Review
- 84 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
464 later devices descend from it, 4 citing it directly. 1 of the 465 devices in this family, counting this one, has a Class I recall.
- This deviceK954330 Super Screw 3.5 MMOsteomed Corp. · 1995
- Descendant · cites it directly · 310 of its ownK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
- Descendant · cites it directly · 246 of its ownK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- Descendant · 2 generations on · 219 of its ownK103705 Low Profile ScrewsArthrex, Inc. · 2011
- Descendant · 2 generations on · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
- Descendant · 3 generations on · 135 of its ownK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
Showing 5 of 464 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 464 · See all- K062863Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006 · cites it directly310descendants
- K063298Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007 · cites it directly246descendants
- K103705Low Profile ScrewsArthrex, Inc. · 2011 · 2 generations on219descendants
- K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · 2 generations on161descendants
- K111253Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011 · 3 generations on135descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954330 | Super Screw 3.5 MM | Osteomed Corp. | 1995 | — |
| +1 | K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw System | Osteomed LP | 2006 | — |
| +1 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| +2 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| +2 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
| +3 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 12 | 0 |
| 2012 | 8 | 0 |
| 2013 | 15 | 0 |
| 2014 | 21 | 0 |
| 2015 | 30 | 0 |
| 2016 | 11 | 0 |
| 2017 | 38 | 0 |
| 2018 | 16 | 0 |
| 2019 | 24 | 0 |
| 2020 | 31 | 0 |
| 2021 | 35 | 1 |
| 2022 | 34 | 0 |
| 2023 | 37 | 0 |
| 2024 | 44 | 0 |
| 2025 | 44 | 0 |
| 2026 | 60 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (464)
See all 4644 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K062863 (Osteomed LP, 2006) has gone furthest, with 310 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 | — |
https://510kreport.com/device/K954330 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954330: Super Screw 3.5 MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954330
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026