510(k) · Cleared
ClearedBiolok Screw, Biosteon Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocomposites, Ltd. · HWC Screw, Fixation, Bone
Cleared on Feb 8, 2001 after a 73-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Feb 8, 2001
- Review
- 73 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK003641 Biolok Screw, Biosteon ScrewBiocomposites, Ltd. · 2001
- Descendant · cites it directly · 1 of its ownK021351 Biosteon Cross PinBiocomposites, Ltd. · 2002 · Recalled
- Descendant · cites it directly · 0 of its ownK251680 Biosteon® ScrewBiocomposites, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK081390 Bioactif Osteotrans Interfence ScrewTakiron Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK050468 Triabsorb Composite ScrewAdvanced Biomaterials · 2005
- Descendant · 2 generations on · 0 of its ownK033792 Bilok ST ScrewBiocomposites, Ltd. · 2004
Most influential descendants
Showing 5 of 5 · See all- K021351Biosteon Cross PinBiocomposites, Ltd. · 2002 · cites it directly1descendant
- K251680Biosteon® ScrewBiocomposites, Ltd. · 2026 · cites it directly0descendants
- K081390Bioactif Osteotrans Interfence ScrewTakiron Co., Ltd. · 2008 · cites it directly0descendants
- K050468Triabsorb Composite ScrewAdvanced Biomaterials · 2005 · cites it directly0descendants
- K033792Bilok ST ScrewBiocomposites, Ltd. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003641 | Biolok Screw, Biosteon Screw | Biocomposites, Ltd. | 2001 | — |
| +1 | K021351 | Biosteon Cross Pin | Biocomposites, Ltd. | 2002 | 1 |
| +1 | K251680 | Biosteon® Screw | Biocomposites, Ltd. | 2026 | — |
| +1 | K081390 | Bioactif Osteotrans Interfence Screw | Takiron Co., Ltd. | 2008 | — |
| +1 | K050468 | Triabsorb Composite Screw | Advanced Biomaterials | 2005 | — |
| +2 | K033792 | Bilok ST Screw | Biocomposites, Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | — | Bio Interference Screw (Arthrex) Named without a submission number | |
| * | — | BioScrew (Livatec) Named without a submission number | |
| * | — | BioLok® Screw (Biocomposites) Named without a submission number |
What descends from it? (5)
4 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, K021351 (Biocomposites, Ltd., 2002) has gone furthest, with 1 descendant 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 Biosteon™ Screw is indicated for use in anterior cruciate ligament (ACL)
reconstruction procedures where the surgeon:
e places the graft in tibial and/or femoral tunnels; and
e inserts screws between the tunnel wall and graft to hold the graft in place.
The Biosteon™ Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
The Biosteon™ Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
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/K003641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003641: Biolok Screw, Biosteon Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003641
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026