510(k) · Cleared
ClearedINTRAFIX (TM) Advance Tibial Fastener System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Jul 19, 2016 as substantially equivalent to K123362 (Depuy Mitek, A Johnson & Johnson Company, 2013) after a 118-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Jul 19, 2016
- Review
- 118 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K971358 (1997). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 6 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 5 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 4 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 3 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 2 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 1 generation backK123362 Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2013
- This deviceK160804 INTRAFIX (TM) Advance Tibial Fastener SystemMedos International SARL · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −6 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −5 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −4 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −3 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −2 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −1 | K123362 | Milagro Advance Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| 0 (this device) | K160804 | INTRAFIX (TM) Advance Tibial Fastener System | Medos International SARL | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 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? (1)
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 4…mon Name: Fastener, fixation, soft tissue Substantial The INTRAFIX™ Advance Tibial Fastener System is substantially equivalent to: Equivalence K123362 MILAGRO® ADVANCE Interference Screw Reference devices: K130539 Healix Advance™ Knotless… | 2013 |
| † | K130539 | Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM) | 2013 |
| † | K102443 | Intrafix Tibial Sheath | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 companies; a new generation was cleared every 2.2 years on median.
- None of the 10 ancestors has a recall.
- 3 other devices also cite its predicate K123362.
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. 2016, 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 DePuy Mitek INTRAFIX™ Advance Tibial Sheath and Screw System is indicated for fixation of tissue including
ligament, or tendon to bone during cruciate ligament reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160804: INTRAFIX (TM) Advance Tibial Fastener System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160804
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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