510(k) · Cleared
ClearedMilagro Advance Interference Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · HWC Screw, Fixation, Bone
Cleared on Feb 1, 2013 as substantially equivalent to K060830 (Depuy Mitek, A Johnson & Johnson Company, 2006) and 1 other predicate after a 92-day review. Its family tree reaches back 6 generations to 1997. 5 later devices descend from it.
- Decided
- Feb 1, 2013
- Review
- 92 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K971358 (1997). 9 ancestors in all. 5 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 deviceK123362 Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2013
- Descendant · cites it directly · 2 of its ownK161001 MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL · 2016
- Descendant · cites it directly · 1 of its ownK240441 MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek · 2024
- Descendant · 2 generations on · 0 of its ownK252022 OSSIOfiber® Interference ScrewOSSIO, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK160804 INTRAFIX (TM) Advance Tibial Fastener SystemMedos International SARL · 2016
- Descendant · cites it directly · 0 of its ownK140324 Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company · 2014
Most influential descendants
Showing 5 of 5 · See all- K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL · 2016 · cites it directly2descendants
- K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek · 2024 · cites it directly1descendant
- K252022OSSIOfiber® Interference ScrewOSSIO, Ltd. · 2025 · 2 generations on0descendants
- K160804INTRAFIX (TM) Advance Tibial Fastener SystemMedos International SARL · 2016 · cites it directly0descendants
- K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company · 2014 · cites it directly0descendants
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) | K123362 | Milagro Advance Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| +1 | K161001 | MILAGRO ADVANCE PEEK Interference Screw | Medos International SARL | 2016 | — |
| +1 | K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw | Depuy Mitek | 2024 | — |
| +2 | K252022 | OSSIOfiber® Interference Screw | OSSIO, Ltd. | 2025 | — |
| +1 | K160804 | INTRAFIX (TM) Advance Tibial Fastener System | Medos International SARL | 2016 | — |
| +1 | K140324 | Rigidloop Adjustable Cortical Implant: Standard, Long and XL | Depuy Mitek, A Johnson and Johnson Company | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2024 | 1 | 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 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 |
|---|---|---|---|
| * | K060830 | Milagro Interference ScrewSummary page 1…fastener, fixation, biodegradable, soft tissue Substantial The MILAGRO ADVANCE Interference Screw is substantially equivalent to: Equivalence * K060830: MILAGRO Interference Screw Facility * K032717: Biocryl Rapide Interference Screw Device HWC - Smoo… | 2006 |
| * | K032717 | Biocryl Rapide Interference ScrewSummary page 1…ial The MILAGRO ADVANCE Interference Screw is substantially equivalent to: Equivalence * K060830: MILAGRO Interference Screw Facility * K032717: Biocryl Rapide Interference Screw Device HWC - Smooth or threaded metallic bone fixation fastener, classified as… | 2004 |
What descends from it? (5)
4 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 16 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K161001 (Medos International SARL, 2016) has gone furthest, with 2 descendants of its own.
- 9 other devices also cite its predicate K060830.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 MILAGRO ADVANCE Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.
Additionally, the 7, 8 and 9 mm x 23 mm screws will be indicated for: medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123362: Milagro Advance Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123362
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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