510(k) · Cleared
ClearedDepuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Jul 21, 2011 as substantially equivalent to K060830 (Depuy Mitek, A Johnson & Johnson Company, 2006) and 4 other predicates after a 203-day review. Its family tree reaches back 6 generations to 1997. 18 later devices descend from it.
- Decided
- Jul 21, 2011
- Review
- 203 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K971358 (1997). 12 ancestors in all. 18 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 5 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 4 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 3 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 2 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 1 generation backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- This deviceK103831 Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807…Depuy Mitek, A Johnson & Johnson Company · 2011
- Descendant · cites it directly · 13 of its ownK112249 Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company · 2011
- Descendant · 2 generations on · 9 of its ownK130917 Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2013 · Recalled
- Descendant · 2 generations on · 4 of its ownK130539 Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013
- Descendant · 3 generations on · 3 of its ownK131974 Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013
- Descendant · 3 generations on · 3 of its ownK131683 Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company · 2011 · cites it directly13descendants
- K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2013 · 2 generations on9descendants
- K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013 · 2 generations on4descendants
- K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013 · 3 generations on3descendants
- K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −5 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −4 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −3 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −2 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −1 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| 0 (this device) | K103831 | Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809 | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| +1 | K112249 | Healix Knotless (TM) Anchor | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| +2 | K130917 | Healix Advance Knotless BR Anchor | Depuy Mitek, A Johnson & Johnson Company | 2013 | 2 |
| +2 | K130539 | Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM) | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| +3 | K131974 | Healix Advance Knotless BR Anchor (6.5MM) | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| +3 | K131683 | Healix Advance Knotless Peek Anchor (6.5MM) | Depuy Mitek, Inc., A Johnson and Johnson Company | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 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? (5)
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 |
|---|---|---|---|
| * | K060830 | Milagro Interference ScrewSummary page 1…Mitek Milagro® Interference Screws SUBSTANTIAL EQUIVALENCE Small Size DePuy Mitek Milagro® Interference Screws are substantially equivalent to the following devices. * K060830 Milagro® Interference Screws * K032717 Milagro® Interference Screw/previously known as Biocryl Rapide Interference-Screw * K… | 2006 |
| * | K032717 | Biocryl Rapide Interference ScrewSummary page 1…TIAL EQUIVALENCE Small Size DePuy Mitek Milagro® Interference Screws are substantially equivalent to the following devices. * K060830 Milagro® Interference Screws * K032717 Milagro® Interference Screw/previously known as Biocryl Rapide Interference-Screw * KO0I1726,041356,020043 Arthrex T… | 2004 |
| * | K051726 | Arthrex Tenodesis Family Our reading of the summary gave K001726, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Arthrex Tenodesis Screw Family”. | 2005 |
| * | K041356 | Arthrex Tenodesis Screw FamilySummary page 1…the following devices. * K060830 Milagro® Interference Screws * K032717 Milagro® Interference Screw/previously known as Biocryl Rapide Interference-Screw * KO0I1726,041356,020043 Arthrex Tenadesis Screw Family FDA PRODUCT CODE MAI, HWC DEVICE CLASSIFICATION This type of fixation screw… | 2004 |
| * | K020043 | 4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM Arthrex Bio-Tenodesis Screw…Summary page 1…lowing devices. * K060830 Milagro® Interference Screws * K032717 Milagro® Interference Screw/previously known as Biocryl Rapide Interference-Screw * KO0I1726,041356,020043 Arthrex Tenadesis Screw Family FDA PRODUCT CODE MAI, HWC DEVICE CLASSIFICATION This type of fixation screw was ori… | 2002 |
What descends from it? (18)
See all 184 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?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K112249 (Depuy Mitek, A Johnson & Johnson Company, 2011) has gone furthest, with 13 descendants of its own.
- 9 other devices also cite its predicate K060830.
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. 2011, this device’s year, is highlighted.
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?
The Small Size DePuy Mitek Milagro® Interference Screws are indicated as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103831: Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103831
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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