510(k) · Cleared
ClearedJuggerknot Mini Soft Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Sports Medicine · DZL Screw, Fixation, Intraosseous
Cleared on Oct 2, 2014 as substantially equivalent to K992623 (Mitek Products, 1999) and 3 other predicates after a 176-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Oct 2, 2014
- Review
- 176 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K962793 (1996). 12 ancestors in all, the oldest K921873 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK962793 Mitek Micro AnchorMitek Products · 1996
- 3 generations backK032078 Mitek Micro QuickanchorMitek Worldwide · 2003
- 2 generations backK080352 Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix…Depuy Mitek, A Johnson & Johnson Company · 2008
- 1 generation backK110879 Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorBiomet Sports Medicine · 2011 · Recalled
- This deviceK140908 Juggerknot Mini Soft AnchorBiomet Sports Medicine · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962793 | Mitek Micro Anchor | Mitek Products | 1996 | — |
| −3 | K032078 | Mitek Micro Quickanchor | Mitek Worldwide | 2003 | — |
| −2 | K080352 | Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+… | Depuy Mitek, A Johnson & Johnson Company | 2008 | — |
| −1 | K110879 | Biomet Sports Medicine Juggerknot (TM) Mini Soft Anchor | Biomet Sports Medicine | 2011 | 2 |
| 0 (this device) | 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 | 2 | 0 |
| 2003 | 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 DZL? 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 DZL device
- #1 K254286 Guided Bone Regeneration Systemscore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K992623 | Mitek Mini AnchorSummary page 4…ous fixation screw or wire (21 CFR 872.4880) DZL. Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K992623 Mitek® Mini Anchor K992487 Mitek Mini QUICKANCHOR Plus K080352 Mitek Mini QUICKANCHOR Plus and Microfix… | 1999 |
| * | K992487 | Mitek Mini Quickanchor PlusSummary page 4…(21 CFR 872.4880) DZL. Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K992623 Mitek® Mini Anchor K992487 Mitek Mini QUICKANCHOR Plus K080352 Mitek Mini QUICKANCHOR Plus and Microfix QUICKANCHOR Plus K110879 B… | 1999 |
| * | K080352 | Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+ Anchor with…Summary page 4…) DZL. Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K992623 Mitek® Mini Anchor K992487 Mitek Mini QUICKANCHOR Plus K080352 Mitek Mini QUICKANCHOR Plus and Microfix QUICKANCHOR Plus K110879 Biomet Sports Medicine JuggerKnot™ Mini Soft Anc… | 2008 |
| * | K110879 | Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorSummary page 4…K992623 Mitek® Mini Anchor K992487 Mitek Mini QUICKANCHOR Plus K080352 Mitek Mini QUICKANCHOR Plus and Microfix QUICKANCHOR Plus K110879 Biomet Sports Medicine JuggerKnot™ Mini Soft Anchors Device Description: The JuggerKnot™ Mini Soft Anchors consist of a core… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 2 other devices also cite its predicate K992623.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DZL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZL
263in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZL
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZL
70in 2025
MAUDE reports naming product code DZL, 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 | 1 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 3 | 89 | 1 | 17 |
| 2011 | 2 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 236 |
| 2013 | 1 | — | 3 | 178 |
| 2014 | 2 | — | 0 | 106 |
| 2015 | 1 | — | 0 | 103 |
| 2016 | 1 | — | 0 | 34 |
| 2017 | 3 | 277 | 0 | 74 |
| 2018 | 0 | — | 0 | 57 |
| 2019 | 2 | — | 0 | 50 |
| 2020 | 1 | — | 0 | 85 |
| 2021 | 1 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 162 |
| 2023 | 2 | — | 0 | 100 |
| 2024 | 2 | — | 0 | 106 |
| 2025 | 4 | 263 | 0 | 70 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The JuggerKnot™ Mini Soft Anchors are intended to be used for soft tissue to bone fixation with indications for use in:
Maxillofacial
For the repair, repositioning or reattachment of soft tissues, ligament and tendons to the mandible for surgical stabilization of the TMJ articular disc.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140908 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140908: Juggerknot 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/K140908
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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