510(k) · Cleared
ClearedMilagro / Milagro 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 · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on May 21, 2015 as substantially equivalent to K121018 (Smith & Nephew, Inc., 2012) and 1 other predicate after a 149-day review. Its family tree reaches back 7 generations to 1996. 4 later devices descend from it.
- Decided
- May 21, 2015
- Review
- 149 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K961555 (1996). 15 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 6 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 4 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 3 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- 2 generations backK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · Recalled
- 1 generation backK121018 Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless…Smith & Nephew, Inc. · 2012
- This deviceK143660 Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2015
- 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 ownK210122 Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)Osteonic Co., Ltd. · 2021
Most influential descendants
Showing 4 of 4 · 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
- K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)Osteonic Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −6 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −5 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −4 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −3 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| −2 | K082215 | Osteoraptor Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2008 | 9 |
| −1 | K121018 | Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an | Smith & Nephew, Inc. | 2012 | — |
| 0 (this device) | K143660 | Milagro / Milagro Advance Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2015 | — |
| +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 | K210122 | Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) | Osteonic Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 1 | 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 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 |
|---|---|---|---|
| * | K121018 | Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSummary page 4…ssories Name Regulatory Class Class II Product Code MAI (21CFR888.3030) III. PREDICATE DEVICE Predicate Device Bioraptor Knotless Anchor (K121018, K093428; Smith & Nephew) Reference BioTenodesis Interference Screw (K051726, K041356, K020043; Arthre… | 2012 |
| * | K093428 | Smith & Nephew Knotless Instability AnchorSummary page 4…ame Regulatory Class Class II Product Code MAI (21CFR888.3030) III. PREDICATE DEVICE Predicate Device Bioraptor Knotless Anchor (K121018, K093428; Smith & Nephew) Reference BioTenodesis Interference Screw (K051726, K041356, K020043; Arthrex) Device… | 2009 |
| † | K051726 | Arthrex Tenodesis Family | 2005 |
| † | K041356 | Arthrex Tenodesis Screw Family | 2004 |
| † | K020043 | 4.0 MM Arthrex Bio-Tendoesis Screw, Model AR-1540B; 5.5 MM Arthrex Bio-Tenodesis Screw… | 2002 |
What descends from it? (4)
3 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 19 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 5 of the 15 ancestors have a recall of any class.
- Of its descendants, K161001 (Medos International SARL, 2016) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K121018.
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. 2015, 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 Interference Screw (5x12, 6x12, 7x15, 8x15) The MILAGRO BR Interference Screws are 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) Milagro Advance Interference Screw…
Read the full statement (125 words)
Milagro Interference Screw (5x12, 6x12, 7x15, 8x15)
The MILAGRO BR Interference Screws are 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)
Milagro Advance Interference Screw (7x23, 8x23, 9x23)
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 9mm x 23mm screws are indicated for: medial and lateral collateral ligament repair, medial patellofemoral ligament reconstruction (femur fixation) 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/K143660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143660: Milagro / 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/K143660
Report an extraction error
Are you the manufacturer?
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