510(k) · Cleared
ClearedMILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Mar 15, 2024 as substantially equivalent to K103831 (Depuy Mitek, A Johnson & Johnson Company, 2011) and 3 other predicates after a 30-day review. Its family tree reaches back 9 generations to 1996. 1 later device descends from it.
- Decided
- Mar 15, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K961555 (1996). 31 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 5 generations between
- 3 generations backK121018 Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless…Smith & Nephew, Inc. · 2012
- 2 generations backK143660 Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2015
- 1 generation backK161001 MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL · 2016
- This deviceK240441 MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek · 2024
- Descendant · cites it directly · 0 of its ownK252022 OSSIOfiber® Interference ScrewOSSIO, Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 8 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 7 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 6 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 5 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- 4 generations backK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · Recalled
- 3 generations backK121018 Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless…Smith & Nephew, Inc. · 2012
- 2 generations backK143660 Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2015
- 1 generation backK161001 MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL · 2016
- This deviceK240441 MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek · 2024
Most influential descendants
Showing 1 of 1 · See all- K252022OSSIOfiber® Interference ScrewOSSIO, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −8 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −7 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −6 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −5 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| −4 | K082215 | Osteoraptor Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2008 | 9 |
| −3 | K121018 | Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an | Smith & Nephew, Inc. | 2012 | — |
| −2 | K143660 | Milagro / Milagro Advance Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2015 | — |
| −1 | K161001 | MILAGRO ADVANCE PEEK Interference Screw | Medos International SARL | 2016 | — |
| 0 (this device) | K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw | Depuy Mitek | 2024 | — |
| +1 | K252022 | OSSIOfiber® Interference Screw | OSSIO, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K103831 | Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809Summary page 10…Substantial The MILAGRO Interference Screws (23mm, 30mm lengths) are substantially Equivalence equivalent to predicate: • K103831 MILAGRO Interference Screws The MILAGRO Interference Screws (12mm, 15mm lengths) and MILAGRO… | 2011 |
| * | K143660 | Milagro / Milagro Advance Interference ScrewSummary page 11…1 of 5 K240441 • K143660 MILAGRO, MILAGRO ADVANCE Interference Screws The MILAGRO ADVANCE BR Screws (30mm lengths) are substantially… | 2015 |
| * | K123362 | Milagro Advance Interference ScrewSummary page 11…Interference Screws The MILAGRO ADVANCE BR Screws (30mm lengths) are substantially equivalent to predicate: • K123362 MILAGRO ADVANCE Interference Screws The MILAGRO ADVANCE PEEK Screws are substantially equivalent to… | 2013 |
| * | K161001 | MILAGRO ADVANCE PEEK Interference ScrewSummary page 11…LAGRO ADVANCE Interference Screws The MILAGRO ADVANCE PEEK Screws are substantially equivalent to predicate: • K161001 MILAGRO ADVANCE PEEK Interference Screws Device The MILGRO and MILAGRO ADVANCE Interference Screws are classified as… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252022 | OSSIOfiber® Interference Screw | 2025 | 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 28 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 5 of the 31 ancestors have a recall of any class.
- Of its descendants, K252022 (OSSIO, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K103831.
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. 2024, 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?
MILAGRO ADVANCE PEEK Interference Screws (7x23mm, 8x23mm, 9x23mm): The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows: » Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures. » Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction » Knee: Medial and lateral collateral ligament repair » Knee…
Read the full statement (542 words)
MILAGRO ADVANCE PEEK Interference Screws (7x23mm, 8x23mm, 9x23mm):
The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows:
» Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.
» Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
» Knee: Medial and lateral collateral ligament repair
» Knee: Medial patellofemoral ligament reconstruction (femur fixation)
* Shoulder: Proximal Biceps Tenodesis
* Elbow: Distal Biceps Tenodesis
* Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
MILAGRO ADVANCE PEEK Interference Screws (7x30mm, 8x30mm):
The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows:
» Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.
» Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
* Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
MILAGRO ADVANCE BR Interference Screws (7x23mm, 8x23mm, 9x23mm):
The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows:
» Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.
» Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
» Knee: Medial and lateral collateral ligament repair, medial patellofemoral ligament reconstruction (femur fixation)
* Shoulder: Proximal Biceps Tenodesis
* Elbow: Distal Biceps Tenodesis
* Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
MILAGRO ADVANCE BR Interference Screws (8x30mm, 7x30mm):
The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows:
» Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.
» Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
* Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
MILAGRO BR Interference Screws (7x15mm, 6x12mm, 5x12mm):
The DePuy Mitek MILAGRO BR Interference Screws designed to attach soft tissues to bone in orthopedic surgical procedures for the following indications:
* Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair
* Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament Repair
*» Knee: Collateral Ligament Repair, Medial Patellofemoral Ligament Reconstruction (patella fixation)
* Foot and Ankle: Lateral Stabilization, Medial Stabilization, Mid-Foot Reconstruction, Tendon Transfer in the Foot and Ankle
MILAGRO BR Interference Screws (5x23mm, 5x30mm, 6x23mm, 6x30mm):
The DePuy Mitek MILAGRO Interference Screw is indicated as follows:
» Knee: (ST) graft to the tibia and/or femur during cruciate ligament reconstruction procedures
» Knee: Medial and lateral collateral ligament repair*
* Shoulder: Proximal bicep tenodesis*
* Elbow: Distal bicep tenodesis*
* Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle
* These indications do not apply to 5x30mm Screws and 6x30mm Screws
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/K240441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240441: MILAGRO Interference Screw; 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/K240441
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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