510(k) Report

510(k) · Cleared

Cleared

Innovasive Devices Intratunnel Tibial Fixation Fastener

K983560510(k) TraditionalCleared Jan 28, 1999107-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Innovasive Devices, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jan 28, 1999 after a 107-day review. The FDA summary names its predicate without a number. 22 later devices descend from it.

Decided
Jan 28, 1999
Review
107 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
0

22 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared2004: 1 descendant cleared2010: 3 descendants cleared2007: 1 descendant cleared2003: 1 descendant cleared2012: 2 descendants cleared2009: 2 descendants cleared2015: 1 descendant cleared2023: 1 descendant cleared2020: 1 descendant cleared2013: 3 descendants cleared2017: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant cleared2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK983560 Innovasive Devices Intratunnel Tibial Fixation FastenerInnovasive Devices, Inc. · 1999
  2. Descendant · cites it directly · 15 of its ownK032167 Bio-Intrafix Tibial Screw and SheathMitek Worldwide · 2003
  3. Descendant · cites it directly · 7 of its ownK063577 Femoral Intrafix Screw and SheathJohnson & Johnson Company · 2007
  4. 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
  5. Descendant · 2 generations on · 4 of its ownK130539 Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013
  6. Descendant · 3 generations on · 3 of its ownK131683 Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12007: 12009: 22010: 32011: 22012: 22013: 32015: 12017: 12018: 12020: 12023: 12024: 12026: 1
2003high 3 (2010) · low 0 (2005)2026

Most influential descendants

Showing 5 of 22 · See all
  • K032167Bio-Intrafix Tibial Screw and SheathMitek Worldwide · 2003 · cites it directly15descendants
  • K063577Femoral Intrafix Screw and SheathJohnson & Johnson Company · 2007 · cites it directly7descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K983560Innovasive Devices Intratunnel Tibial Fixation FastenerInnovasive Devices, Inc.1999—
+1K032167Bio-Intrafix Tibial Screw and SheathMitek Worldwide2003—
+1K063577Femoral Intrafix Screw and SheathJohnson & Johnson Company2007—
+1K1221236-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered…Depuy Mitek, Inc., A Johnson and Johnson Company2012—
+2K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company2013—
+3K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200710
200920
201030
201120
201220
201330
201510
201710
201810
202010
202310
202410
202610
FIG. 1 — Lineage of K983560, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—RCI Screw
Named without a submission number
—

What descends from it? (22)

See all 22

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032167Bio-Intrafix Tibial Screw and SheathMitek Worldwide200315
K063577Femoral Intrafix Screw and SheathJohnson & Johnson Company20077
K1221236-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered Screw…Depuy Mitek, Inc., A Johnson and Johnson Company20125
K040542Smith & Nephew GTS Sleeve and GTS Tapered ScrewSmith & Nephew, Inc.20043
K103145Hammerloc TM Tibial Fixation DeviceBiomet Sports Medicine20111
K093943Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MMSmith & Nephew Inc., Endoscopy Div.20101
K102443Intrafix Tibial SheathDepuy Mitek, A Johnson & Johnson Company20100

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?

  • Of its descendants, K032167 (Mitek Worldwide, 2003) has gone furthest, with 15 descendants of its own.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBI

27in 2025

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
2007high 24 (2007) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MBI

3,826in 2025

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

What is it indicated for?

The intended use of the Intratunnel Tibial Fixation Fastener is for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Innovasive Devices, Inc.

34 FDA decisions under this applicant name. See the company

  • K994269Titan RC TackInnovasive Devices, Inc. · 2000
  • K993975Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
  • K992458RC Multisuture Bone Anchor, Model 4453/4454Innovasive Devices, Inc. · 1999
  • K992377RC TackInnovasive Devices, Inc. · 1999
  • K990454Bio-Interference ScrewInnovasive Devices, Inc. · 1999

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K983560 · printed Nov 5, 2026

Cite this page

510(k) Report. “K983560: Innovasive Devices Intratunnel Tibial Fixation Fastener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983560

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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