510(k) · Cleared
Recalled · Class II · 2018Biomet Sports Medicine Juggerknot Soft Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 4, 2011 as substantially equivalent to K071704 (Biomet Sports Medicine, Inc., 2007) after a 45-day review. Its family tree reaches back 4 generations to 1990. 83 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 4, 2011
- Review
- 45 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K904436 (1990). 14 ancestors in all, the oldest K813581 (1982). 83 later devices descend from it, 10 citing it directly.
- Root · 4 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 3 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 2 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 1 generation backK071704 Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc. · 2007
- This deviceK110145 Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc. · 2011
- Descendant · cites it directly · 40 of its ownK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
- Descendant · cites it directly · 29 of its ownK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- Descendant · 2 generations on · 28 of its ownK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
- Descendant · 3 generations on · 21 of its ownK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
- Descendant · 2 generations on · 17 of its ownK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015 · cites it directly40descendants
- K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011 · cites it directly29descendants
- K180768Arthrex SwiveLock AnchorsArthrex, Inc. · 2018 · 2 generations on28descendants
- K191226Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019 · 3 generations on21descendants
- K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec · 2013 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −3 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −2 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −1 | K071704 | Sleeve and Button Soft Tissue Devices | Biomet Sports Medicine, Inc. | 2007 | — |
| 0 (this device) | K110145 | Biomet Sports Medicine Juggerknot Soft Anchor | Biomet, Inc. | 2011 | — |
| +1 | K150768 | JuggerKnot Soft Anchors | Biomet Manufacturing Corp | 2015 | — |
| +1 | K111779 | Y-Knot All-Suture Anchor Model HF13 | Conmed Linvatec | 2011 | — |
| +2 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
| +3 | K191226 | Arthrex SwiveLock Suture Anchor | Arthrex, Inc. | 2019 | — |
| +2 | K131035 | Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM | Linvatec Corporation D/B/A Conmed Linvatec | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 8 | 0 |
| 2022 | 3 | 0 |
| 2023 | 12 | 0 |
| 2024 | 7 | 0 |
| 2025 | 11 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K071704 | Sleeve and Button Soft Tissue DevicesSummary page 1…xation, nondegradable, soft tissue (21CFR §888.3040) MBI Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K071704 Sleeve and Button Soft Tissue Fixation Devices / Biomet Sports Medicine Device Description: The JuggerKnot TM Soft Anchors c… | 2007 |
What descends from it? (83)
See all 8310 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150768 | JuggerKnot Soft Anchors | 2015 | 40 |
| K111779 | Y-Knot All-Suture Anchor Model HF13 | 2011 | 29 |
| K233429 | OTS 25 (100-1) | 2023 | 2 |
| K130458 | Knotless Fibertak Suture Anchor | 2013 | 2 |
| K182898 | TenoTac Soft Tissue Fixation System | 2019 | 1 |
| K141219 | Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument Kits | 2014 | 1 |
| K122059 | All-Suture Anchor Twist Drill for All-Suture Anchors Inline Drill Guide for All-Suture… | 2013 | 1 |
| K122805 | Parcus Draw Tight 1.8MM Single-Loaded Suture Anchor | 2013 | 1 |
| K141263 | Toggleloc and Juggerloc Implants/Instruments/Kits | 2014 | 0 |
| K123485 | Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors… | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 3, 2018 | Class II | Z-3252-2018 | Device Design | Expiration date incorrectly listed on the label |
| 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… |
| Jul 21, 2011 | Not classified | Z-3109-2011 | Package design/selection | The device packaging was punctured by the device, resulting in loss of implant sterility. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K150768 (Biomet Manufacturing Corp, 2015) has gone furthest, with 40 descendants of its own.
- 3 other devices also cite its predicate K071704.
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 Soft Anchors are intended for soft tissue to bone flxation for the following indications: Shoulder Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis Foot and Ankle Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction…
Read the full statement (112 words)
The JuggerKnot TM Soft Anchors are intended for soft tissue to bone flxation for the following indications:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament
Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110145 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110145: Biomet Sports Medicine Juggerknot Soft Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110145
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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