510(k) · Cleared
ClearedJuggerKnot Soft Anchors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Sep 4, 2015 as substantially equivalent to K110145 (Biomet, Inc., 2011) and 1 other predicate after a 164-day review. Its family tree reaches back 8 generations to 1979. 40 later devices descend from it.
- Decided
- Sep 4, 2015
- Review
- 164 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K792022 (1979). 59 ancestors in all. 40 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 7 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 6 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 5 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 4 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 3 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 2 generations backK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- 1 generation backK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
- This deviceK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
- Descendant · cites it directly · 28 of its ownK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
- Descendant · 2 generations on · 21 of its ownK191226 Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019
- Descendant · 3 generations on · 13 of its ownK203495 Arthrex SwiveLock AnchorArthrex, Inc. · 2021 · Recalled
- Descendant · cites it directly · 5 of its ownK203740 JuggerKnot Soft AnchorRiverpoint Medical · 2021
- Descendant · 2 generations on · 4 of its ownK232973 Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc. · 2023
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K180768Arthrex SwiveLock AnchorsArthrex, Inc. · 2018 · cites it directly28descendants
- K191226Arthrex SwiveLock Suture AnchorArthrex, Inc. · 2019 · 2 generations on21descendants
- K203495Arthrex SwiveLock AnchorArthrex, Inc. · 2021 · 3 generations on13descendants
- K203740JuggerKnot Soft AnchorRiverpoint Medical · 2021 · cites it directly5descendants
- K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc. · 2023 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −7 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −6 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −5 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −4 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −3 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −2 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
| −1 | K123341 | Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button… | Arthrex, Inc. | 2012 | — |
| 0 (this device) | K150768 | JuggerKnot Soft Anchors | Biomet Manufacturing Corp | 2015 | — |
| +1 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
| +2 | K191226 | Arthrex SwiveLock Suture Anchor | Arthrex, Inc. | 2019 | — |
| +3 | K203495 | Arthrex SwiveLock Anchor | Arthrex, Inc. | 2021 | 1 |
| +1 | K203740 | JuggerKnot Soft Anchor | Riverpoint Medical | 2021 | — |
| +2 | K232973 | Arthrex Knee FiberTak® Button Suture Anchor | Arthrex, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K110145 | Biomet Sports Medicine Juggerknot Soft AnchorSummary page 5…ft Tissue (21 CFR 888.3040) Legally marketed devices to which substantial equivalence is claimed: • Biomet JuggerKnot Soft Anchors (K110145) • Arthrex Pec Button (K123341) Device Description The JuggerKnot Soft Anchors consists of a coreless sleeve structure an… | 2011 |
| * | K123341 | Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Summary page 5…(21 CFR 888.3040) Legally marketed devices to which substantial equivalence is claimed: • Biomet JuggerKnot Soft Anchors (K110145) • Arthrex Pec Button (K123341) Device Description The JuggerKnot Soft Anchors consists of a coreless sleeve structure and suture. The anchors are intended fo… | 2012 |
What descends from it? (40)
See all 406 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 36 years and passes through 7 companies; a new generation was cleared every 2.7 years on median.
- 10 of the 59 ancestors have a recall of any class.
- Of its descendants, K180768 (Arthrex, Inc., 2018) has gone furthest, with 28 descendants of its own.
- 9 other devices also cite its predicate K110145.
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. 2015, 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 Soft Anchors are intended for soft tissue to bone fixation 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, Pectoralis major repair Foot and Ankle: Medial/lateral repair and reconstruction, mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon…
Read the full statement (155 words)
The JuggerKnot Soft Anchors are intended for soft tissue to bone fixation 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, Pectoralis major repair
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, Medial Patellofemoral Ligament (MPFL) repair or reconstruction, Quadriceps tendon repair
Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip: Acetabular labral repair, Proximal hamstring repair
The JuggerKnot Self-Punching Soft Anchors are intended for soft tissue to bone fixation for the following indications:
Shoulder: Rotator cuff tear repair
Foot and Ankle: Achilles tendon repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150768: JuggerKnot Soft Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150768
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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