510(k) · Cleared
ClearedEndobutton Direct
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Inc., Endoscopy Division · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Jan 5, 2011 as substantially equivalent to K980155 (Smith & Nephew, Inc., 1998) after a 90-day review. Its family tree reaches back 2 generations to 1992. 36 later devices descend from it.
- Decided
- Jan 5, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K922559 (1992). 3 ancestors in all. 36 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK922559 Acufex Endofix ButtonAcufex Microsurgical, Inc. · 1992
- 1 generation backK980155 Endobutton Continuous LoopSmith & Nephew, Inc. · 1998
- This deviceK102982 Endobutton DirectSmith & Nephew Inc., Endoscopy Division · 2011
- Descendant · cites it directly · 35 of its ownK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- Descendant · 2 generations on · 4 of its ownK231857 Arthrex TightRope IIArthrex, Inc. · 2023
- Descendant · 3 generations on · 3 of its ownK241235 Arthrex TightRope IIArthrex, Inc. · 2024
- Descendant · 2 generations on · 3 of its ownK211770 R3ACT Stabilization SystemParagon 28, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK173278 ToggleLoc SystemBiomet, Inc. · 2018
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K130033Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Biomet Manufacturing Corp · 2013 · cites it directly35descendants
- K231857Arthrex TightRope IIArthrex, Inc. · 2023 · 2 generations on4descendants
- K241235Arthrex TightRope IIArthrex, Inc. · 2024 · 3 generations on3descendants
- K211770R3ACT Stabilization SystemParagon 28, Inc. · 2021 · 2 generations on3descendants
- K173278ToggleLoc SystemBiomet, Inc. · 2018 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922559 | Acufex Endofix Button | Acufex Microsurgical, Inc. | 1992 | — |
| −1 | K980155 | Endobutton Continuous Loop | Smith & Nephew, Inc. | 1998 | — |
| 0 (this device) | K102982 | Endobutton Direct | Smith & Nephew Inc., Endoscopy Division | 2011 | — |
| +1 | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc… | Biomet Manufacturing Corp | 2013 | 3 |
| +2 | K231857 | Arthrex TightRope II | Arthrex, Inc. | 2023 | — |
| +3 | K241235 | Arthrex TightRope II | Arthrex, Inc. | 2024 | — |
| +2 | K211770 | R3ACT Stabilization System | Paragon 28, Inc. | 2021 | — |
| +2 | K173278 | ToggleLoc System | Biomet, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 4 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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 |
|---|---|---|---|
| * | K980155 | Endobutton Continuous LoopSummary page 1…Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: The Smith & Nephew Endobutton CL (K980155). k o 2Aib 2> E. Description of Device The ENDOBUTTON DIRECT is a machined… | 1998 |
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB… | 2013 | 35 |
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 19 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K130033 (Biomet Manufacturing Corp, 2013) has gone furthest, with 35 descendants of its own.
- 13 other devices also cite its predicate K980155.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Smith & Nephew ENDOBUTTON DIRECT Fixation Device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102982: Endobutton Direct.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102982
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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