510(k) · Cleared
ClearedBiolok Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Orthopedics, Inc. · HWC Screw, Fixation, Bone
Cleared on Apr 26, 2000 after a 182-day review. The FDA summary names its predicate without a number. 128 later devices descend from it.
- Decided
- Apr 26, 2000
- Review
- 182 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
128 later devices descend from it, 2 citing it directly.
- This deviceK993630 Biolok ScrewEncore Orthopedics, Inc. · 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 128 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 128 · 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) | K993630 | Biolok Screw | Encore Orthopedics, Inc. | 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 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 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 | 11 | 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 (Linvatec) Named without a submission number |
What descends from it? (128)
See all 1282 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, 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:
e 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 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/K993630 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993630: Biolok Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993630
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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