510(k) · Cleared
ClearedBio-Interference Screw, 7 MM, 8 MM, 9 MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Jul 9, 1997 after an 89-day review. The FDA summary names its predicate without a number. 135 later devices descend from it.
- Decided
- Jul 9, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 0
135 later devices descend from it, 5 citing it directly.
- This deviceK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- Descendant · cites it directly · 119 of its ownK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- Descendant · 2 generations on · 118 of its ownK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- Descendant · 2 generations on · 117 of its ownK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- Descendant · 3 generations on · 107 of its ownK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- Descendant · 4 generations on · 103 of its ownK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
Showing 5 of 135 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 135 · See all- K990454Bio-Interference ScrewInnovasive Devices, Inc. · 1999 · cites it directly119descendants
- K993975Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999 · 2 generations on118descendants
- K013572Mitek Biocryl Interference ScrewsMitek Products · 2002 · 2 generations on117descendants
- K032717Biocryl Rapide Interference ScrewMitek Worldwide · 2004 · 3 generations on107descendants
- K060830Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006 · 4 generations on103descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| +1 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| +2 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| +2 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| +3 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| +4 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 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 |
|---|---|---|---|
| * | — | Arthrex, Inc.’s Bio-Interference Screw Named without a submission number | |
| * | — | Linvatec’s BioScrew Named without a submission number |
What descends from it? (135)
See all 1355 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990454 | Bio-Interference Screw | 1999 | 119 |
| K993073 | Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025… | 1999 | 16 |
| K021280 | Inion Hexalon Biodegradable Acl/PCL Screw | 2002 | 1 |
| K032830 | Plla Cannulated Interference Screw | 2004 | 0 |
| K031939 | Bio-Eurolig Interference 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, K990454 (Innovasive Devices, Inc., 1999) has gone furthest, with 119 descendants of its own.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
To provide interference fixation of bone-tendon-bone and soft tissue- grafts in ACIL, reconstruction through arthroscopy or arthrotory.
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/K971358 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971358: Bio-Interference Screw, 7 MM, 8 MM, 9 MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971358
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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