510(k) Report

510(k) · Cleared

Cleared

Mli Soft Tissue Screw & Washer System

K962194510(k) TraditionalCleared Jul 30, 199653-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

Medicinelodge, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jul 30, 1996 after a 53-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.

Decided
Jul 30, 1996
Review
53 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
0

7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 2 descendants cleared2013: 1 descendant cleared2020: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2023: 1 descendant cleared1995200020052010201520202025
  1. This deviceK962194 Mli Soft Tissue Screw & Washer SystemMedicinelodge, Inc. · 1996
  2. Descendant · cites it directly · 5 of its ownK981967 Washerloc Screw System, Ligament Screw System, NO-Profile…Arthrotek/Biomet, Inc. · 1998
  3. Descendant · 2 generations on · 4 of its ownK122437 NO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc…Biomet Sports Medicine · 2013
  4. Descendant · 2 generations on · 3 of its ownK193214 WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated…Biomet, Inc. · 2020
  5. Descendant · 3 generations on · 2 of its ownK211290 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
  6. Descendant · 4 generations on · 0 of its ownK242691 OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1998: 22013: 12020: 12021: 12023: 12024: 1
1998high 2 (1998) · low 0 (1999)2026

Most influential descendants

Showing 5 of 7 · See all
  • K981967Washerloc Screw System, Ligament Screw System, NO-Profile BI-Cortical Screw System…Arthrotek/Biomet, Inc. · 1998 · cites it directly5descendants
  • K122437NO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc WashersBiomet Sports Medicine · 2013 · 2 generations on4descendants
  • K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc. · 2020 · 2 generations on3descendants
  • K211290Cannulated Fasteners and NutsOsteoCentric Technologies · 2021 · 3 generations on2descendants
  • K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962194Mli Soft Tissue Screw & Washer SystemMedicinelodge, Inc.1996—
+1K981967Washerloc Screw System, Ligament Screw System, NO-Profile BI-Cortical Screw…Arthrotek/Biomet, Inc.1998—
+2K122437NO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc WashersBiomet Sports Medicine2013—
+2K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw…Biomet, Inc.2020—
+3K211290Cannulated Fasteners and NutsOsteoCentric Technologies2021—
+4K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
201310
202010
202110
202310
202410
FIG. 1 — Lineage of K962194, 1996–2024Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—Linvatec Concept Soft Tissue Anchoring Implants
Named without a submission number
—
*—Arthrotek Ligament Screw System
Named without a submission number
—
*—Mitek Screws and Washers
Named without a submission number
—

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K981967Washerloc Screw System, Ligament Screw System, NO-Profile BI-Cortical Screw System…Arthrotek/Biomet, Inc.19985
K983056Innovasive Tibial FastenerInnovasive Devices, Inc.19980

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, K981967 (Arthrotek/Biomet, Inc., 1998) has gone furthest, with 5 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?

MedicineLodge, Inc. soft tissue anchoring bone screws and washers are indicated for use in soft tissue graft fixations to the femur or tibia, or both, during cruciate ligament, tendon or other soft tissue graft (e.g. semitendinosus) repair procedures.

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

More from Medicinelodge, Inc.

8 FDA decisions under this applicant name. See the company

  • K072525Zipknot, Model 1017-3000Medicinelodge, Inc. · 2007
  • K051488Medicinelodge ZipknotMedicinelodge, Inc. · 2005
  • K962705Mli Modular StapleMedicinelodge, Inc. · 1996
  • K961920Cross PinMedicinelodge, Inc. · 1996
  • K961905Medicinelodge, Inc. Set ScrewMedicinelodge, Inc. · 1996

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/K962194 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962194: Mli Soft Tissue Screw & Washer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962194

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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