510(k) · Cleared
Recalled · Class II · 2022Toggleloc and Juggerloc Implants/Instruments/Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · JDR Staple, Fixation, Bone
Cleared on Nov 19, 2014 as substantially equivalent to K130033 (Biomet Manufacturing Corp, 2013) and 2 other predicates after a 188-day review. Its family tree reaches back 11 generations to 1991. It has been recalled 2 times.
- Decided
- Nov 19, 2014
- Review
- 188 days
- Class
- Class II
- Product code
- JDR
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 11 generations to K911837 (1991). 118 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 11 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 7 generations between
- 3 generations backK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- 2 generations backK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- 1 generation backK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013
- This deviceK141263 Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp · 2014
Show all 11 generations
- Root · 11 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 10 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 9 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 8 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 7 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 6 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 5 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 4 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 3 generations backK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- 2 generations backK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- 1 generation backK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013
- This deviceK141263 Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −10 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −9 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −8 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −7 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −6 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −5 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −4 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| −3 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
| −2 | K111779 | Y-Knot All-Suture Anchor Model HF13 | Conmed Linvatec | 2011 | — |
| −1 | 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 | — |
| 0 (this device) | K141263 | Toggleloc and Juggerloc Implants/Instruments/Kits | Biomet Manufacturing Corp | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 16 | 0 |
| 1997 | 13 | 0 |
| 1998 | 9 | 0 |
| 1999 | 10 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 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 JDR? 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 JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Summary page 4…21 CFR 888.3030) MBI – Fastener, Fixation, nondegradable, soft tissue (21 CFR 888.3040) Legally Marketed Predicates: Biomet ToggleLoc System (K130033) Biomet JuggerKnot Soft Anchor (K110145) Conmed-Linvatec Y-Knot Anchor (K131035) Device Description:… | 2013 |
| * | K110145 | Biomet Sports Medicine Juggerknot Soft AnchorSummary page 4…n, nondegradable, soft tissue (21 CFR 888.3040) Legally Marketed Predicates: Biomet ToggleLoc System (K130033) Biomet JuggerKnot Soft Anchor (K110145) Conmed-Linvatec Y-Knot Anchor (K131035) Device Description: The JuggerLoc and 2.9 ToggleLoc Soft Tis… | 2011 |
| * | K131035 | Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMSummary page 4…lly Marketed Predicates: Biomet ToggleLoc System (K130033) Biomet JuggerKnot Soft Anchor (K110145) Conmed-Linvatec Y-Knot Anchor (K131035) Device Description: The JuggerLoc and 2.9 ToggleLoc Soft Tissue System is a non-resorbable system intended to… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 14, 2022 | Class II | Z-0809-2022 | Under Investigation by firm | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find… |
| Feb 26, 2015 | Class II | Z-1363-2015 | Employee error | The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 15 of the 118 ancestors have a recall of any class.
- 16 other devices also cite its predicate K130033.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, 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 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
The 2.9 ToggleLoc and JuggerLoc Soft Tissue devices are intended for soft tissue to bone fixation for the following indications: Shoulder Bankart lesion repair SLAP lesion repairs 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…
Read the full statement (95 words)
The 2.9 ToggleLoc and JuggerLoc Soft Tissue devices are intended for soft tissue to bone fixation for the following indications:
Shoulder
Bankart lesion repair
SLAP lesion repairs
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
Extracapsular repair: MCL, LCL, and posterior oblique ligament
Illiotibial band tenodesis
Patellar tendon repair
VMO advancement
Joint capsule closure
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141263: Toggleloc and Juggerloc Implants/Instruments/Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141263
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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