510(k) · Cleared
ClearedArthrotek Maxfire Meniscal Repair Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrotek, Inc. · JDR Staple, Fixation, Bone
Cleared on Sep 25, 2006 as substantially equivalent to K041988 (Biomet, Inc., 2004) and 1 other predicate after a 94-day review. Its family tree reaches back 2 generations to 1997. 6 later devices descend from it.
- Decided
- Sep 25, 2006
- Review
- 94 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K965228 (1997). 4 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK965228 Fasterner, Fixation, Biodegradable Soft TissueUnited States Surgical, A Division of Tyco Healthc · 1997
- 1 generation backK041988 Arthrotek Meniscal Hybrid DeviceBiomet, Inc. · 2004
- This deviceK061776 Arthrotek Maxfire Meniscal Repair DeviceArthrotek, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK111564 Maxfire Marxmen Meniscal Repair DeviceBiomet Sports Medicine · 2011
- Descendant · 2 generations on · 2 of its ownK190125 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK221731 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK150424 JuggerStitch Meniscal Repair DeviceBiomet Manufacturing Corp · 2015
- Descendant · 4 generations on · 0 of its ownK244015 SuperBall-RC™Arcuro Medical, Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K111564Maxfire Marxmen Meniscal Repair DeviceBiomet Sports Medicine · 2011 · cites it directly5descendants
- K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2019 · 2 generations on2descendants
- K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2022 · 3 generations on1descendant
- K150424JuggerStitch Meniscal Repair DeviceBiomet Manufacturing Corp · 2015 · 2 generations on1descendant
- K244015SuperBall-RC™Arcuro Medical, Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K965228 | Fasterner, Fixation, Biodegradable Soft Tissue | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −1 | K041988 | Arthrotek Meniscal Hybrid Device | Biomet, Inc. | 2004 | — |
| 0 (this device) | K061776 | Arthrotek Maxfire Meniscal Repair Device | Arthrotek, Inc. | 2006 | — |
| +1 | K111564 | Maxfire Marxmen Meniscal Repair Device | Biomet Sports Medicine | 2011 | — |
| +2 | K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire… | T.A.G. Medical Products Corporation, Ltd. | 2019 | — |
| +3 | K221731 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire… | T.A.G. Medical Products Corporation, Ltd. | 2022 | — |
| +2 | K150424 | JuggerStitch Meniscal Repair Device | Biomet Manufacturing Corp | 2015 | — |
| +4 | K244015 | SuperBall-RC™ | Arcuro Medical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 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 K243658 TMC Compression Implant Systemscore 16.7 · 18 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 |
|---|---|---|---|
| * | K041988 | Arthrotek Meniscal Hybrid DeviceSummary page 1…ture Anchor Classification Name: Bone Fixation Appliances and Accessories (21 CFR 888.3030) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K041988 - Arthrotek® Meniscal Hybrid Device (Biomet Manufacturing Corp.) K040472 - Force Fiber Blue Co-Braid Polyethylene Non-Absorbable… | 2004 |
| * | K040472 | Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical SutureSummary page 1…ssories (21 CFR 888.3030) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K041988 - Arthrotek® Meniscal Hybrid Device (Biomet Manufacturing Corp.) K040472 - Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture (Teleflex Medical) Device Description: The Arthrotek® Max… | 2004 |
What descends from it? (6)
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 9 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K111564 (Biomet Sports Medicine, 2011) has gone furthest, with 5 descendants of its own.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, 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 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
The Arthrotek® Maxfire TM Meniscal Repair 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 zones of the meniscus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061776 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061776: Arthrotek Maxfire Meniscal Repair Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061776
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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