510(k) · Cleared
ClearedFemoral Intrafix Screw and Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Company · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jan 25, 2007 as substantially equivalent to K983560 (Innovasive Devices, Inc., 1999) and 2 other predicates after a 56-day review. Its family tree reaches back 5 generations to 1997. 7 later devices descend from it.
- Decided
- Jan 25, 2007
- Review
- 56 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K971358 (1997). 9 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 4 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 3 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 2 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 1 generation backK032167 Bio-Intrafix Tibial Screw and SheathMitek Worldwide · 2003
- This deviceK063577 Femoral Intrafix Screw and SheathJohnson & Johnson Company · 2007
- Descendant · cites it directly · 5 of its ownK122123 6-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek…Depuy Mitek, Inc., A Johnson and Johnson Company · 2012
- Descendant · 2 generations on · 4 of its ownK130539 Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013
- Descendant · 3 generations on · 3 of its ownK131683 Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013
- Descendant · 3 generations on · 2 of its ownK171114 HEALIX ADVANCE KNOTLESS AnchorMedos International SARL · 2017
- Descendant · 3 generations on · 1 of its ownK180101 HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K1221236-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered Screw…Depuy Mitek, Inc., A Johnson and Johnson Company · 2012 · cites it directly5descendants
- K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013 · 2 generations on4descendants
- K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013 · 3 generations on3descendants
- K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL · 2017 · 3 generations on2descendants
- K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −4 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −3 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −2 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −1 | K032167 | Bio-Intrafix Tibial Screw and Sheath | Mitek Worldwide | 2003 | — |
| 0 (this device) | K063577 | Femoral Intrafix Screw and Sheath | Johnson & Johnson Company | 2007 | — |
| +1 | K122123 | 6-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered… | Depuy Mitek, Inc., A Johnson and Johnson Company | 2012 | — |
| +2 | K130539 | Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM) | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| +3 | K131683 | Healix Advance Knotless Peek Anchor (6.5MM) | Depuy Mitek, Inc., A Johnson and Johnson Company | 2013 | — |
| +3 | K171114 | HEALIX ADVANCE KNOTLESS Anchor | Medos International SARL | 2017 | — |
| +3 | K180101 | HEALIX ADVANCE KNOTLESS BR Anchor | Medos International SARL | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K983560 | Innovasive Devices Intratunnel Tibial Fixation FastenerSummary page 1…crew and Sheath Substantial Equivalence The Femoral Intrafix Screw and Sheath is substantially equivalent to: Intrafix Screw and Sheath (K983560); the Milagro Interference Screw (K032717) and the Bio-Intrafix Screw and Sheath (K032167). Device… | 1999 |
| * | K032717 | Biocryl Rapide Interference ScrewSummary page 1…w and Sheath is substantially equivalent to: Intrafix Screw and Sheath (K983560); the Milagro Interference Screw (K032717) and the Bio-Intrafix Screw and Sheath (K032167). Device Classification This device carries an FDA product code MBI and H… | 2004 |
| * | K032167 | Bio-Intrafix Tibial Screw and SheathSummary page 1…Intrafix Screw and Sheath (K983560); the Milagro Interference Screw (K032717) and the Bio-Intrafix Screw and Sheath (K032167). Device Classification This device carries an FDA product code MBI and HWC, and is classifie… | 2003 |
What descends from it? (7)
2 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 10 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K122123 (Depuy Mitek, Inc., A Johnson and Johnson Company, 2012) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K983560.
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. 2007, 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 Femoral Intrafix Screw and Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063577 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063577: Femoral Intrafix Screw and Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063577
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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