510(k) · Cleared
ClearedJuggerKnot Soft Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riverpoint Medical · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Feb 12, 2021 as substantially equivalent to K150768 (Biomet Manufacturing Corp, 2015) after a 52-day review. Its family tree reaches back 9 generations to 1979. 5 later devices descend from it.
- Decided
- Feb 12, 2021
- Review
- 52 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K792022 (1979). 60 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 5 generations between
- 3 generations backK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- 2 generations backK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
- 1 generation backK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
- This deviceK203740 JuggerKnot Soft AnchorRiverpoint Medical · 2021
- Descendant · cites it directly · 2 of its ownK232411 JuggerKnot Soft Anchor OCRiverpoint Medical, LLC · 2023
- Descendant · cites it directly · 0 of its ownK242494 OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK243203 OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical · 2024
- Descendant · 2 generations on · 0 of its ownK240719 OC JuggerKnot Soft AnchorRiverpoint Medical · 2024
- Descendant · cites it directly · 0 of its ownK231128 JuggerKnot Soft AnchorRiverpoint Medical, LLC · 2023
Show all 9 generations
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 7 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 6 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 5 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 4 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 3 generations backK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- 2 generations backK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
- 1 generation backK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
- This deviceK203740 JuggerKnot Soft AnchorRiverpoint Medical · 2021
Most influential descendants
Showing 5 of 5 · See all- K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC · 2023 · cites it directly2descendants
- K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC · 2024 · cites it directly0descendants
- K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical · 2024 · 2 generations on0descendants
- K240719OC JuggerKnot Soft AnchorRiverpoint Medical · 2024 · 2 generations on0descendants
- K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −8 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −7 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −6 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −5 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −4 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −3 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
| −2 | K123341 | Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button… | Arthrex, Inc. | 2012 | — |
| −1 | K150768 | JuggerKnot Soft Anchors | Biomet Manufacturing Corp | 2015 | — |
| 0 (this device) | K203740 | JuggerKnot Soft Anchor | Riverpoint Medical | 2021 | — |
| +1 | K232411 | JuggerKnot Soft Anchor OC | Riverpoint Medical, LLC | 2023 | — |
| +1 | K242494 | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct | Riverpoint Medical, LLC | 2024 | — |
| +2 | K243203 | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor | Riverpoint Medical | 2024 | — |
| +2 | K240719 | OC JuggerKnot Soft Anchor | Riverpoint Medical | 2024 | — |
| +1 | K231128 | JuggerKnot Soft Anchor | Riverpoint Medical, LLC | 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 |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K150768 | JuggerKnot Soft AnchorsSummary page 4…on Division of Orthopedic Devices, Restorative and Repair Devices Branch (RRDB) Predicate Device K150768 – Zimmer Biomet JuggerKnot® Soft Anchor No reference devices were used in this submission.… | 2015 |
What descends from it? (5)
3 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 42 years and passes through 8 companies; a new generation was cleared every 2.7 years on median.
- 10 of the 60 ancestors have a recall of any class.
- Of its descendants, K232411 (Riverpoint Medical, LLC, 2023) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K150768.
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. 2021, 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?
Indicated for use in soft tissue to bone fixation for the following indications:
Knee MPFL
Knee Patellar tendon repair
Knee MCL
Knee Quadriceps tendon repair
Hip Acetabular labral repair
Hip Proximal hamstring repair.
Hip Hip labral reconstruction.
Foot and Ankle Achilles tendon repair
Foot and Ankle Medial/lateral repair and reconstruction
Foot and Ankle Plantar plate repair
Foot and Ankle Mid- and forefoot repair
Foot and Ankle Metatarsal ligament/tendon repair or reconstruction
Shoulder Rotator Cuff
Shoulder Shoulder Instability
Shoulder Biceps Tenodesis
Elbow Lateral epicondylitis repair
Elbow Biceps tendon reattachment
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/K203740 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203740: 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/K203740
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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