510(k) · Cleared
ClearedIntrafix Tibial Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Oct 20, 2010 as substantially equivalent to K983560 (Innovasive Devices, Inc., 1999) and 1 other predicate after a 55-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Oct 20, 2010
- Review
- 55 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K971358 (1997). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 5 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 4 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 3 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 2 generations backK032167 Bio-Intrafix Tibial Screw and SheathMitek Worldwide · 2003
- 1 generation backK063577 Femoral Intrafix Screw and SheathJohnson & Johnson Company · 2007
- This deviceK102443 Intrafix Tibial SheathDepuy Mitek, A Johnson & Johnson Company · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −5 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −4 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −3 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −2 | K032167 | Bio-Intrafix Tibial Screw and Sheath | Mitek Worldwide | 2003 | — |
| −1 | K063577 | Femoral Intrafix Screw and Sheath | Johnson & Johnson Company | 2007 | — |
| 0 (this device) | K102443 | Intrafix Tibial Sheath | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K983560 | Innovasive Devices Intratunnel Tibial Fixation FastenerSummary page 1…e Bone Anchor Intrafix Tibial Sheath SUBSTANTIAL EQUIVALENCE Intrafix Tibial Sheath is substantially equivalent to the following devices. *Intrafix Tibial Sheath (K983560) - Modified Device * Femoral Intrafix (K063577) FDA PRODUCT CODE MBI DEVICE CLASSIFICATION This type of fixation sheath was o… | 1999 |
| * | K063577 | Femoral Intrafix Screw and SheathSummary page 1…TIAL EQUIVALENCE Intrafix Tibial Sheath is substantially equivalent to the following devices. *Intrafix Tibial Sheath (K983560) - Modified Device * Femoral Intrafix (K063577) FDA PRODUCT CODE MBI DEVICE CLASSIFICATION This type of fixation sheath was originally classified as a Class 1I medical device… | 2007 |
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 13 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.
- 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. 2010, 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?
Intrafix Tibial Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102443: Intrafix Tibial Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102443
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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