510(k) · Cleared
ClearedMaxfire Marxmen Meniscal Repair Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Sports Medicine · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jun 16, 2011 as substantially equivalent to K061776 (Arthrotek, Inc., 2006) after a 10-day review. Its family tree reaches back 3 generations to 1997. 5 later devices descend from it.
- Decided
- Jun 16, 2011
- Review
- 10 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K965228 (1997). 5 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK965228 Fasterner, Fixation, Biodegradable Soft TissueUnited States Surgical, A Division of Tyco Healthc · 1997
- 2 generations backK041988 Arthrotek Meniscal Hybrid DeviceBiomet, Inc. · 2004
- 1 generation backK061776 Arthrotek Maxfire Meniscal Repair DeviceArthrotek, Inc. · 2006
- This deviceK111564 Maxfire Marxmen Meniscal Repair DeviceBiomet Sports Medicine · 2011
- Descendant · cites it directly · 2 of its ownK190125 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2019
- Descendant · 2 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 · cites it directly · 1 of its ownK150424 JuggerStitch Meniscal Repair DeviceBiomet Manufacturing Corp · 2015
- Descendant · 3 generations on · 0 of its ownK244015 SuperBall-RC™Arcuro Medical, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK191459 JuggerStitch Meniscal Repair DeviceBiomet, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2019 · cites it directly2descendants
- K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2022 · 2 generations on1descendant
- K150424JuggerStitch Meniscal Repair DeviceBiomet Manufacturing Corp · 2015 · cites it directly1descendant
- K244015SuperBall-RC™Arcuro Medical, Ltd. · 2025 · 3 generations on0descendants
- K191459JuggerStitch Meniscal Repair DeviceBiomet, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K965228 | Fasterner, Fixation, Biodegradable Soft Tissue | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −2 | K041988 | Arthrotek Meniscal Hybrid Device | Biomet, Inc. | 2004 | — |
| −1 | K061776 | Arthrotek Maxfire Meniscal Repair Device | Arthrotek, Inc. | 2006 | — |
| 0 (this device) | K111564 | Maxfire Marxmen Meniscal Repair Device | Biomet Sports Medicine | 2011 | — |
| +1 | K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire… | T.A.G. Medical Products Corporation, Ltd. | 2019 | — |
| +2 | K221731 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire… | T.A.G. Medical Products Corporation, Ltd. | 2022 | — |
| +1 | K150424 | JuggerStitch Meniscal Repair Device | Biomet Manufacturing Corp | 2015 | — |
| +3 | K244015 | SuperBall-RC™ | Arcuro Medical, Ltd. | 2025 | — |
| +2 | K191459 | JuggerStitch Meniscal Repair Device | Biomet, Inc. | 2019 | — |
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 |
|---|---|---|
| 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061776 | Arthrotek Maxfire Meniscal Repair DeviceSummary page 1…ulation 888.3040 Product Code(s) MBI Legally marketed device(s) Arthrotek® MaxFire TM Meniscal Repair Device - K061776 to which equivalence is claimed Reason for 510(k) Device Modification submission Device description… | 2006 |
What descends from it? (5)
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 14 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K190125 (T.A.G. Medical Products Corporation, Ltd., 2019) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K061776.
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. 2011, 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?
The Biomet Sports Medicine TM MaxfireTM MarXmenTM 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 zone of the meniscus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111564 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111564: Maxfire Marxmen Meniscal Repair Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111564
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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