510(k) · Cleared
Recalled · 2009Bone Mulch Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HWC Screw, Fixation, Bone
Cleared on Feb 2, 1995 after a 287-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled once.
- Decided
- Feb 2, 1995
- Review
- 287 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK941941 Bone Mulch ScrewBiomet, Inc. · 1995
- Descendant · cites it directly · 6 of its ownK993025 Modification to Bone Mulch Screw SystemBiomet, Inc. · 1999
- Descendant · cites it directly · 4 of its ownK042552 Bio-Core Interference ScrewBiomet, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK140879 Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK071464 Inion Hexalon Biodegradable Acl/PCL ScrewInion OY · 2007
- Descendant · 3 generations on · 0 of its ownK142948 BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc. · 2015 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K993025Modification to Bone Mulch Screw SystemBiomet, Inc. · 1999 · cites it directly6descendants
- K042552Bio-Core Interference ScrewBiomet, Inc. · 2004 · cites it directly4descendants
- K140879Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc. · 2014 · 2 generations on1descendant
- K071464Inion Hexalon Biodegradable Acl/PCL ScrewInion OY · 2007 · 2 generations on1descendant
- K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941941 | Bone Mulch Screw | Biomet, Inc. | 1995 | — |
| +1 | K993025 | Modification to Bone Mulch Screw System | Biomet, Inc. | 1999 | — |
| +1 | K042552 | Bio-Core Interference Screw | Biomet, Inc. | 2004 | — |
| +2 | K140879 | Biosure Healicoil PK Interference Screw | Smith & Nephew, Inc. | 2014 | — |
| +2 | K071464 | Inion Hexalon Biodegradable Acl/PCL Screw | Inion OY | 2007 | — |
| +3 | K142948 | BIOSURE REGENESORB interference Screw | Smith & Nephew, Inc. | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2009 | Not classified | Z-0779-2010 | Employee error | The screw may not have the hex dimension inside of the head of the screw, which will prevent the device from being implantable. This may cause a delay in the procedure while another screw is obtained. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K993025 (Biomet, Inc., 1999) has gone furthest, with 6 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/K941941 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941941: Bone Mulch Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941941
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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