510(k) · Cleared
ClearedBio-Interference Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasive Devices, Inc. · HWC Screw, Fixation, Bone
Cleared on Jul 1, 1999 as substantially equivalent to K971358 (Arthrex, Inc., 1997) after a 139-day review. Its family tree reaches back 1 generation to 1997. 119 later devices descend from it.
- Decided
- Jul 1, 1999
- Review
- 139 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971358 (1997). 119 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- This deviceK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- Descendant · cites it directly · 118 of its ownK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 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
Showing 5 of 119 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 119 · See all- K993975Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999 · cites it directly118descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| 0 (this device) | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| +1 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MMSummary page 1…ade Name: Innovasive Bio-Interference Screw Common Name: Interference Screw Classification Name: Not Classified 5. PREDICATE DEVICE: (1) Arthrex Bio-Interference Screw - K971358 4. DEVICE DESCRIPTION: The Bio-Interference Screw is a biodegradable interference screw intended for interference fit fixation of… | 1997 |
What descends from it? (119)
See all 1192 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?
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 Bio-Interference Screw is intended for 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/K990454 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990454: Bio-Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990454
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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