510(k) · Cleared
ClearedJuggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · HTN Washer, Bolt Nut
Cleared on Jul 18, 2014 as substantially equivalent to K130033 (Biomet Manufacturing Corp, 2013) and 2 other predicates after a 67-day review. Its family tree reaches back 11 generations to 1979. 1 later device descends from it.
- Decided
- Jul 18, 2014
- Review
- 67 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K792022 (1979). 71 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 7 generations between
- 3 generations backK071978 Mini Tightrope FT Repair KitArthrex, Inc. · 2007
- 2 generations backK090107 Mini TightropeArthrex, Inc. · 2009
- 1 generation backK133275 Mini TightropeArthrex, Inc. · 2014
- This deviceK141219 Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and…Biomet Manufacturing Corp · 2014
- Descendant · cites it directly · 0 of its ownK172620 SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC · 2017
Show all 11 generations
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 10 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 9 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 8 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 7 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 6 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 5 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 4 generations backK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- 3 generations backK071978 Mini Tightrope FT Repair KitArthrex, Inc. · 2007
- 2 generations backK090107 Mini TightropeArthrex, Inc. · 2009
- 1 generation backK133275 Mini TightropeArthrex, Inc. · 2014
- This deviceK141219 Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and…Biomet Manufacturing Corp · 2014
Most influential descendants
Showing 1 of 1 · See all- K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −10 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −9 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −8 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −7 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −6 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −5 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −4 | K061925 | Mini Tightrope Repair Kit, Model AR-8911DS | Arthrex, Inc. | 2006 | — |
| −3 | K071978 | Mini Tightrope FT Repair Kit | Arthrex, Inc. | 2007 | — |
| −2 | K090107 | Mini Tightrope | Arthrex, Inc. | 2009 | — |
| −1 | K133275 | Mini Tightrope | Arthrex, Inc. | 2014 | — |
| 0 (this device) | K141219 | Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument… | Biomet Manufacturing Corp | 2014 | — |
| +1 | K172620 | SyndesMetrics Syndesmosis Repair System | Mortise Medical, LLC | 2017 | — |
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 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 HTN? 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 HTN device
- #1 K201522 Arthrex Syndesmosis TightRope XP Buttress…score 16.4 · 6 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 1…el Orthopedics Regulation 21 CFR § 888.3030 Product Codle(s) HTN - washer, bolt nut Legally marketed device(s) to K(130033 - Biomet ToggleL-oc System which equivalence is claimed K(110145 - Biomet JuggerKnot Soft Anchors… | 2013 |
| * | K110145 | Biomet Sports Medicine Juggerknot Soft AnchorSummary page 1…888.3030 Product Codle(s) HTN - washer, bolt nut Legally marketed device(s) to K(130033 - Biomet ToggleL-oc System which equivalence is claimed K(110145 - Biomet JuggerKnot Soft Anchors K(133275 - Arthrex Mini-Tightrope Reason for 510(k) submission… | 2011 |
| * | K133275 | Mini TightropeSummary page 1…arketed device(s) to K(130033 - Biomet ToggleL-oc System which equivalence is claimed K(110145 - Biomet JuggerKnot Soft Anchors K(133275 - Arthrex Mini-Tightrope Reason for 510(k) submission New Device Construct Device description The new JuggerL-o… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172620 | SyndesMetrics Syndesmosis Repair System | 2017 | 0 |
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 35 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 11 of the 71 ancestors have a recall of any class.
- Of its descendants, K172620 (Mortise Medical, LLC, 2017) has gone furthest, with 0 descendants of its own.
- 16 other devices also cite its predicate K130033.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HTN
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTN
75in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTN
190in 2025
MAUDE reports naming product code HTN, 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 | 14 |
| 2008 | 2 | — | 0 | 11 |
| 2009 | 3 | 86 | 0 | 22 |
| 2010 | 0 | — | 0 | 17 |
| 2011 | 4 | 130 | 0 | 12 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 3 | 105 | 1 | 45 |
| 2014 | 8 | 98 | 0 | 33 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 6 | 88 | 0 | 30 |
| 2018 | 2 | — | 0 | 48 |
| 2019 | 5 | 116 | 1 | 53 |
| 2020 | 3 | 87 | 0 | 81 |
| 2021 | 2 | — | 0 | 149 |
| 2022 | 5 | 86 | 0 | 85 |
| 2023 | 2 | — | 0 | 108 |
| 2024 | 6 | 90 | 0 | 269 |
| 2025 | 4 | 75 | 0 | 190 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Biomet JuggerLocT" Bone to Bone system is Intended for repair in the foot and ankle Including indications for:
Midfoot repair including but not limited to Lisfranc repair, ankle syndlesmosis fixation (syndesmosis disruptions), and as an adjunct In connection with trauma hardware for Weber B and C ankle fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141219: Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141219
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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