510(k) · Cleared
Recalled · Class II · 2025Biomet Sports Medicine Juggerknot (TM) Mini Soft Anchor
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 Aug 19, 2011 as substantially equivalent to K992487 (Mitek Products, 1999) and 1 other predicate after a 142-day review. Its family tree reaches back 3 generations to 1996. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 19, 2011
- Review
- 142 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K962793 (1996). 10 ancestors in all, the oldest K921873 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK962793 Mitek Micro AnchorMitek Products · 1996
- 2 generations backK032078 Mitek Micro QuickanchorMitek Worldwide · 2003
- 1 generation backK080352 Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix…Depuy Mitek, A Johnson & Johnson Company · 2008
- This deviceK110879 Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorBiomet Sports Medicine · 2011
- Descendant · cites it directly · 0 of its ownK254229 Arthrex Nano FiberTak Suture AnchorArthrex, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK140908 Juggerknot Mini Soft AnchorBiomet Sports Medicine · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962793 | Mitek Micro Anchor | Mitek Products | 1996 | — |
| −2 | K032078 | Mitek Micro Quickanchor | Mitek Worldwide | 2003 | — |
| −1 | K080352 | Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+… | Depuy Mitek, A Johnson & Johnson Company | 2008 | — |
| 0 (this device) | K110879 | Biomet Sports Medicine Juggerknot (TM) Mini Soft Anchor | Biomet Sports Medicine | 2011 | — |
| +1 | K254229 | Arthrex Nano FiberTak Suture Anchor | Arthrex, Inc. | 2026 | — |
| +1 | K140908 | Juggerknot Mini Soft Anchor | Biomet Sports Medicine | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K992487 | Mitek Mini Quickanchor PlusSummary page 1…on, nondegradable, soft tissue (21CFR §888.3040) MBI Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K(992487 Mitek® Mini QA+ Anchor K(080352 Mitek® Micro QA+ with #3-0, #4-0 Oirthocord Anchor/ Mitek Microfix QA+… | 1999 |
| * | K080352 | Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+ Anchor with…Summary page 1…(21CFR §888.3040) MBI Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K(992487 Mitek® Mini QA+ Anchor K(080352 Mitek® Micro QA+ with #3-0, #4-0 Oirthocord Anchor/ Mitek Microfix QA+ with #3-0, #4-0 Orthocord Ancho Dev… | 2008 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 9, 2025 | Class II | Z-2619-2025 | Under Investigation by firm | The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices. |
| Apr 1, 2016 | Class II | Z-1828-2016 | Equipment maintenance | Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K254229 (Arthrex, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K992487.
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 JuggerKnot TM Mini Soft Anchors are intended to be used for soft tissue to bone fixation with indications for use in:
Shoulder
Bankart repair
Foot and Ankle
Midfoot Reconstruction, Hallux valgus reconstruction
Hand and Wrist
Ulnar or lateral collateral ligament reconstruction, Repair/reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalangeal, DIP (distal interphalangeal), and MVCP (metacarpal interphalangeal) joints for all digits, Scapholunate ligament reconstruction.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110879 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110879: Biomet Sports Medicine Juggerknot (TM) Mini Soft Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110879
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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