510(k) · Cleared
ClearedBone Mulch Screw System
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 May 14, 1999 after a 29-day review. The FDA summary names no predicate by number. 7 later devices descend from it.
- Decided
- May 14, 1999
- Review
- 29 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK991298 Bone Mulch Screw SystemBiomet, Inc. · 1999
- 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) | K991298 | Bone Mulch Screw System | Biomet, Inc. | 1999 | — |
| +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), 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?
The FDA summary names no predicate by number.
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)
No FDA recall names this device.
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 | — |
What is it indicated for?
The Bone Mulch Screw System is indicated for use in anterior cruciate ligament (ACL) reconstruction using semigracilis/semitendinosus or fascia lata (hamstring tendons) graft. It is intended for use in fixing the graft within the femoral graft tunnel.
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/K991298 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991298: Bone Mulch Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991298
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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