510(k) · Cleared
ClearedMitek Biocryl Interference Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitek Products · HWC Screw, Fixation, Bone
Cleared on Mar 14, 2002 as substantially equivalent to K990454 (Innovasive Devices, Inc., 1999) and 3 other predicates after a 136-day review. Its family tree reaches back 3 generations to 1997. 117 later devices descend from it.
- Decided
- Mar 14, 2002
- Review
- 136 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K971358 (1997). 5 ancestors in all. 117 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 2 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 1 generation backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- This deviceK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- Descendant · cites it directly · 107 of its ownK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- Descendant · 2 generations on · 103 of its ownK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- Descendant · 2 generations on · 47 of its ownK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
- Descendant · 2 generations on · 44 of its ownK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
- Descendant · 3 generations on · 38 of its ownK151342 Arthrex SwiveLock AnchorsArthrex, Inc. · 2016
Showing 5 of 117 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 117 · See all- K032717Biocryl Rapide Interference ScrewMitek Worldwide · 2004 · cites it directly107descendants
- K060830Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006 · 2 generations on103descendants
- K071176Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007 · 2 generations on47descendants
- K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · 2 generations on44descendants
- K151342Arthrex SwiveLock AnchorsArthrex, Inc. · 2016 · 3 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −2 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −1 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| 0 (this device) | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| +1 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| +2 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| +2 | K071176 | Modification to: Arthrex Interference Screw | Arthrex, Inc. | 2007 | — |
| +2 | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | 1 |
| +3 | K151342 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 7 | 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? (4)
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 |
|---|---|---|---|
| * | K990454 | Bio-Interference ScrewSummary page 1…w Classification: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Product Code: 87 HWC Predicate Devices: K990454 Bio-Interference Screw K993975 Absolute Absorbable Interference Screw K993630 BioL.ok®Screw K002070 BioLok® Screw Device Descri… | 1999 |
| * | K993975 | Absolute Absorbable Interference ScrewSummary page 1…Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Product Code: 87 HWC Predicate Devices: K990454 Bio-Interference Screw K993975 Absolute Absorbable Interference Screw K993630 BioL.ok®Screw K002070 BioLok® Screw Device Description: The device described in… | 1999 |
| * | K993630 | Biolok ScrewSummary page 1…etic Act, the device classification is Class II. Product Code: 87 HWC Predicate Devices: K990454 Bio-Interference Screw K993975 Absolute Absorbable Interference Screw K993630 BioL.ok®Screw K002070 BioLok® Screw Device Description: The device described in this 510(k) is sterile, disposable implant desig… | 2000 |
| * | K002070 | Biolok ScrewSummary page 1…lassification is Class II. Product Code: 87 HWC Predicate Devices: K990454 Bio-Interference Screw K993975 Absolute Absorbable Interference Screw K993630 BioL.ok®Screw K002070 BioLok® Screw Device Description: The device described in this 510(k) is sterile, disposable implant designed to secure soft tis… | 2000 |
What descends from it? (117)
See all 1176 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032717 | Biocryl Rapide Interference Screw | 2004 | 107 |
| K032167 | Bio-Intrafix Tibial Screw and Sheath | 2003 | 15 |
| K090669 | Rigidfix Biocryl Cross Pin Kits | 2009 | 2 |
| K091041 | Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST… | 2009 | 1 |
| K081390 | Bioactif Osteotrans Interfence Screw | 2008 | 0 |
| K050468 | Triabsorb Composite Screw | 2005 | 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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K032717 (Mitek Worldwide, 2004) has gone furthest, with 107 descendants of its own.
- 1 other device also cites its predicate K990454.
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 Mitek Biocryl Interference Screw is indicated for the fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee
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/K013572 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013572: Mitek Biocryl Interference Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013572
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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