510(k) Report

510(k) · Cleared

Cleared

Arthrotek Meniscal Hybrid Device

K041988510(k) TraditionalCleared Oct 20, 200489-day reviewClass II21 CFR 888.3030

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

Biomet, Inc. · JDR Staple, Fixation, Bone

Cleared on Oct 20, 2004 as substantially equivalent to K982095 (Biomet, Inc., 1999) and 1 other predicate after an 89-day review. Its family tree reaches back 1 generation to 1997. 7 later devices descend from it.

Decided
Oct 20, 2004
Review
89 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K965228 (1997). 2 ancestors in all. 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor2006: 1 descendant cleared2019: 2 descendants cleared2011: 1 descendant cleared2015: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant clearedK965228 · Fasterner, Fixation, Biodegradable Soft Tissue · United States Surgical, A Division of Tyco Healthc · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K965228 · Fasterner, Fixation, Biodegradable Soft Tissue · United States Surgical, A Division of Tyco Healthc · 19970+5
  1. Root · 1 generation backK965228 Fasterner, Fixation, Biodegradable Soft TissueUnited States Surgical, A Division of Tyco Healthc · 1997
  2. This deviceK041988 Arthrotek Meniscal Hybrid DeviceBiomet, Inc. · 2004
  3. Descendant · cites it directly · 6 of its ownK061776 Arthrotek Maxfire Meniscal Repair DeviceArthrotek, Inc. · 2006
  4. Descendant · 2 generations on · 5 of its ownK111564 Maxfire Marxmen Meniscal Repair DeviceBiomet Sports Medicine · 2011
  5. Descendant · 3 generations on · 2 of its ownK190125 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2019
  6. Descendant · 4 generations on · 1 of its ownK221731 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2022
  7. Descendant · 3 generations on · 1 of its ownK150424 JuggerStitch Meniscal Repair DeviceBiomet Manufacturing Corp · 2015

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2006: 12011: 12015: 12019: 22022: 12025: 1
2006high 2 (2019) · low 0 (2007)2026

Most influential descendants

Showing 5 of 7 · See all
  • K061776Arthrotek Maxfire Meniscal Repair DeviceArthrotek, Inc. · 2006 · cites it directly6descendants
  • K111564Maxfire Marxmen Meniscal Repair DeviceBiomet Sports Medicine · 2011 · 2 generations on5descendants
  • K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2019 · 3 generations on2descendants
  • K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2022 · 4 generations on1descendant
  • K150424JuggerStitch Meniscal Repair DeviceBiomet Manufacturing Corp · 2015 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K965228Fasterner, Fixation, Biodegradable Soft TissueUnited States Surgical, A Division of Tyco Healthc1997—
0 (this device)K041988Arthrotek Meniscal Hybrid DeviceBiomet, Inc.2004—
+1K061776Arthrotek Maxfire Meniscal Repair DeviceArthrotek, Inc.2006—
+2K111564Maxfire Marxmen Meniscal Repair DeviceBiomet Sports Medicine2011—
+3K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire…T.A.G. Medical Products Corporation, Ltd.2019—
+4K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire…T.A.G. Medical Products Corporation, Ltd.2022—
+3K150424JuggerStitch Meniscal Repair DeviceBiomet Manufacturing Corp2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201110
201510
201920
202210
202510
FIG. 1 — Lineage of K041988, 1997–2025Source: 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 JDR? 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 JDR device

  1. #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K982095Lactosorb Meniscal Repair Device
Summary page 1
…ication Name: Fastener, Fixation, Biodegradable, Soft Tissue 21 CFR §888.3045 Legally Marketed Devices To Which Substantial Equivalence Is Claimed: * K982095 Lactosorb® Meniscal Repair Device - Biomet Inc., Warsaw, IN * K965228 Surgical Dynamics Meniscal Staple - U.S. Surgical,…
Biomet, Inc.1999—
*K965228Fasterner, Fixation, Biodegradable Soft Tissue
Summary page 1
…88.3045 Legally Marketed Devices To Which Substantial Equivalence Is Claimed: * K982095 Lactosorb® Meniscal Repair Device - Biomet Inc., Warsaw, IN * K965228 Surgical Dynamics Meniscal Staple - U.S. Surgical, Norwalk, CT Device Descrirtion: The Arthrotek Meniscal Hybrid Device incorpo…
United States Surgical, A Division of Tyco Healthc1997—

Also cleared against K982095: 1 other device →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061776Arthrotek Maxfire Meniscal Repair DeviceArthrotek, Inc.20066

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K061776 (Arthrotek, Inc., 2006) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K982095.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDR

3in 2025

2007: 82008: 52010: 22011: 12012: 12013: 92014: 112015: 72016: 62017: 92018: 82019: 52020: 42021: 32022: 52023: 92024: 42025: 32026 (partial year): 2
2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007: 70 days median2008: 89 days median2013: 137 days median2014: 97 days median2015: 111 days median2016: 101 days median2017: 172 days median2018: 107 days median2019: 149 days median2020: 161 days median2021: 62 days median2022: 107 days median2023: 72 days median2024: 29 days median2025: 65 days median
2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2008: 12015: 12018: 12020: 12022: 112026 (partial year): 2
2007high 11 (2022) · low 0 (2007)2026

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

Adverse event reports per year · JDR

314in 2025

2007: 32008: 142009: 102010: 352011: 622012: 342013: 272014: 492015: 482016: 762017: 1162018: 2392019: 2422020: 2342021: 2102022: 2022023: 1752024: 2062025: 314
2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, 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
200787003
2008589114
20090—010
20102—035
20111—062
20121—034
20139137027
20141197049
20157111148
20166101076
201791720116
201881071239
201951490242
202041611234
20213620210
2022510711202
20239720175
20244290206
20253650314
20262—2—

What is it indicated for?

The Arthrotek® Meniscal Hybrid Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

Indications for use as stated in the FDA summary.

Also cleared against K982095

1 other device cites the same predicate.

  • K002020Lactosorb Meniscal ScrewBiomet Manufacturing, Inc. · 2000

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in JDR

The JDR category page

  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K261121Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
  • K250712Linkt Compression Staple SystemTrax Surgical · 2025
  • K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
  • K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025

https://510kreport.com/device/K041988 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041988: Arthrotek Meniscal Hybrid Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041988

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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