510(k) · Cleared
ClearedMILAGRO ADVANCE PEEK Interference Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jun 9, 2016 as substantially equivalent to K123362 (Depuy Mitek, A Johnson & Johnson Company, 2013) and 1 other predicate after a 59-day review. Its family tree reaches back 8 generations to 1996. 2 later devices descend from it.
- Decided
- Jun 9, 2016
- Review
- 59 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K961555 (1996). 26 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 7 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 6 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 5 generations backK061154 Kinsa Suture AnchorSmith & Nephew, Inc. · 2006
- 4 generations backK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- 3 generations backK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · Recalled
- 2 generations backK121018 Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless…Smith & Nephew, Inc. · 2012
- 1 generation backK143660 Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2015
- This deviceK161001 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −7 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −6 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −5 | K061154 | Kinsa Suture Anchor | Smith & Nephew, Inc. | 2006 | — |
| −4 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| −3 | K082215 | Osteoraptor Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2008 | 9 |
| −2 | K121018 | Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an | Smith & Nephew, Inc. | 2012 | — |
| −1 | K143660 | Milagro / Milagro Advance Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2015 | — |
| 0 (this device) | 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 | — |
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 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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 |
|---|---|---|---|
| * | K123362 | Milagro Advance Interference ScrewSummary page 5…Fastener, fixation, nondegradable, soft tissue Substantial The MILAGRO® ADVANCE PEEK Interference Screw is substantially equivalent to: Equivalence K123362, K143660, MILAGRO ADVANCE™ Interference Screw Reference device: K130539 Healix Advance™… | 2013 |
| * | K143660 | Milagro / Milagro Advance Interference ScrewSummary page 5…ener, fixation, nondegradable, soft tissue Substantial The MILAGRO® ADVANCE PEEK Interference Screw is substantially equivalent to: Equivalence K123362, K143660, MILAGRO ADVANCE™ Interference Screw Reference device: K130539 Healix Advance™ Knotless… | 2015 |
| † | K130539 | Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM) | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw | 2024 | 1 |
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 20 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 5 of the 26 ancestors have a recall of any class.
- Of its descendants, K240441 (Depuy Mitek, 2024) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K123362.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The MILAGRO® ADVANCE PEEK 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161001: MILAGRO ADVANCE PEEK 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/K161001
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