510(k) · Cleared
ClearedBiolok 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 Aug 25, 2000 after a 49-day review. The FDA summary names its predicate without a number. 135 later devices descend from it.
- Decided
- Aug 25, 2000
- Review
- 49 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
135 later devices descend from it, 6 citing it directly.
- This deviceK002070 Biolok ScrewBiocomposites, Ltd. · 2000
- Descendant · cites it directly · 117 of its ownK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- Descendant · 2 generations on · 107 of its ownK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- Descendant · 3 generations on · 103 of its ownK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- Descendant · 3 generations on · 47 of its ownK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
- Descendant · 3 generations on · 44 of its ownK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
Showing 5 of 135 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 135 · See all- K013572Mitek Biocryl Interference ScrewsMitek Products · 2002 · cites it directly117descendants
- K032717Biocryl Rapide Interference ScrewMitek Worldwide · 2004 · 2 generations on107descendants
- K060830Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006 · 3 generations on103descendants
- K071176Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007 · 3 generations on47descendants
- K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · 3 generations on44descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002070 | Biolok Screw | Biocomposites, Ltd. | 2000 | — |
| +1 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| +2 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| +3 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| +3 | K071176 | Modification to: Arthrex Interference Screw | Arthrex, Inc. | 2007 | — |
| +3 | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 9 | 0 |
| 2019 | 8 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 12 | 0 |
| 2024 | 7 | 0 |
| 2025 | 10 | 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? (2)
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 |
What descends from it? (135)
See all 1356 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013572 | Mitek Biocryl Interference Screws | 2002 | 117 |
| K032894 | Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T… | 2004 | 15 |
| K050407 | Ligafix Resorbable Interference Screw, Models 30 and 60 | 2005 | 7 |
| K081390 | Bioactif Osteotrans Interfence Screw | 2008 | 0 |
| K050468 | Triabsorb Composite Screw | 2005 | 0 |
| K033792 | Bilok ST Screw | 2004 | 0 |
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, K013572 (Mitek Products, 2002) has gone furthest, with 117 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 BioLok® Screw is indicated for use in anterior cruciate ligament (ACL)
reconstruction procedures where the surgeon:
places the graft in tibial and/or femoral tunnels; and
inserts screws between the tunnel wall and graft to hold the graft in place.
The BioLok® Screw is used to provide interference fixation of patellar bone-tendon-
bone grafts in ACL reconstruction.
The BioLok® Screw is used to provide interference fixation during femoral and/or
tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis
graci lis).
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/K002070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002070: Biolok Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002070
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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