510(k) · Cleared
ClearedEndobutton Continuous Loop (CL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Inc., Endoscopy Division · JDR Staple, Fixation, Bone
Cleared on Jul 16, 2008 as substantially equivalent to K070780 (Conmed Linvatec, 2007) and 1 other predicate after a 90-day review. Its family tree reaches back 8 generations to 1979. 31 later devices descend from it.
- Decided
- Jul 16, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K792022 (1979). 54 ancestors in all. 31 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 backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 1 generation backK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007
- This deviceK081098 Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
- Descendant · cites it directly · 21 of its ownK090923 Parcus Graft Fixation SystemParcus Medical, LLC · 2009
- Descendant · 2 generations on · 16 of its ownK133757 GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC · 2014
- Descendant · 3 generations on · 9 of its ownK160655 OrthoButton CLRiverpoint Medical · 2016
- Descendant · 4 generations on · 8 of its ownK171060 OrthoButton ALRiverpoint Medical · 2017
- Descendant · 2 generations on · 8 of its ownK162198 GFS UltimateParcus Medical, LLC · 2016
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K090923Parcus Graft Fixation SystemParcus Medical, LLC · 2009 · cites it directly21descendants
- K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC · 2014 · 2 generations on16descendants
- K160655OrthoButton CLRiverpoint Medical · 2016 · 3 generations on9descendants
- K171060OrthoButton ALRiverpoint Medical · 2017 · 4 generations on8descendants
- K162198GFS UltimateParcus Medical, LLC · 2016 · 2 generations on8descendants
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 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −1 | K070780 | Conmed Linvatec XO Button | Conmed Linvatec | 2007 | — |
| 0 (this device) | K081098 | Endobutton Continuous Loop (CL) | Smith & Nephew Inc., Endoscopy Division | 2008 | — |
| +1 | K090923 | Parcus Graft Fixation System | Parcus Medical, LLC | 2009 | — |
| +2 | K133757 | GFS II Standard, GFS II Large, GFS Mimi | Parcus Medical, LLC | 2014 | — |
| +3 | K160655 | OrthoButton CL | Riverpoint Medical | 2016 | — |
| +4 | K171060 | OrthoButton AL | Riverpoint Medical | 2017 | — |
| +2 | K162198 | GFS Ultimate | Parcus Medical, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K070780 | Conmed Linvatec XO ButtonSummary page 1…o the currently marketed indications for use of the following legally marketed devices in commercial distribution: the ConMed Linvatec. XO B uttonTM (cleared via K070780) and the Arthrex TightropeTm Acromnioclavicular (AC) Device (cleared via K052776). E. Description of Device ENDOB UITON… | 2007 |
| * | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Summary page 1…vices in commercial distribution: the ConMed Linvatec. XO B uttonTM (cleared via K070780) and the Arthrex TightropeTm Acromnioclavicular (AC) Device (cleared via K052776). E. Description of Device ENDOB UITON CL… | 2005 |
What descends from it? (31)
See all 316 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090923 | Parcus Graft Fixation System | 2009 | 21 |
| K130814 | Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM | 2013 | 3 |
| K101616 | The Grapplr and Grapplr Extender | 2011 | 1 |
| K193165 | MectaFix CL Fixation Button with Continuous Loop | 2020 | 0 |
| K143172 | ACL SMART System | 2015 | 0 |
| K133579 | Multifilament Stainless Steel Sutures with Crimps | 2014 | 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 29 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 54 ancestors have a recall of any class.
- Of its descendants, K090923 (Parcus Medical, LLC, 2009) has gone furthest, with 21 descendants of its own.
- 5 other devices also cite its predicate K070780.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Smith & Nephew ENDOBUTTON Continuous Loop is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction and acromioclavicular joint separations due to coracoclavicular ligament disruptions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081098 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081098: Endobutton Continuous Loop (CL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081098
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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