510(k) · Cleared
ClearedPre-Threaded Endobutton
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Mar 1, 1999 as substantially equivalent to K933948 (Acufex Microsurgical, Inc., 1994) and 2 other predicates after a 69-day review. Its family tree reaches back 2 generations to 1992. 310 later devices descend from it.
- Decided
- Mar 1, 1999
- Review
- 69 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K922559 (1992). 4 ancestors in all. 310 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK922559 Acufex Endofix ButtonAcufex Microsurgical, Inc. · 1992
- 1 generation backK980155 Endobutton Continuous LoopSmith & Nephew, Inc. · 1998
- This deviceK984550 Pre-Threaded EndobuttonSmith & Nephew, Inc. · 1999
- Descendant · cites it directly · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- Descendant · 2 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- Descendant · cites it directly · 97 of its ownK033838 Titanium Toggle Button (S)Biomet Manufacturing, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- Descendant · 2 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
Showing 5 of 310 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 310 · See all- K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · cites it directly306descendants
- K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 2 generations on217descendants
- K033838Titanium Toggle Button (S)Biomet Manufacturing, Inc. · 2004 · cites it directly97descendants
- K083070Toggleloc SystemBiomet Sports Medicine · 2008 · 2 generations on94descendants
- K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 2 generations on91descendants
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) | K984550 | Pre-Threaded Endobutton | Smith & Nephew, Inc. | 1999 | — |
| +1 | 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 | K033838 | Titanium Toggle Button (S) | Biomet Manufacturing, Inc. | 2004 | 1 |
| +2 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
| +2 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 7 | 0 |
| 2014 | 18 | 0 |
| 2015 | 9 | 0 |
| 2016 | 6 | 0 |
| 2017 | 15 | 0 |
| 2018 | 15 | 0 |
| 2019 | 26 | 0 |
| 2020 | 22 | 0 |
| 2021 | 22 | 0 |
| 2022 | 22 | 0 |
| 2023 | 26 | 0 |
| 2024 | 35 | 0 |
| 2025 | 30 | 0 |
| 2026 | 34 | 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 GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 7 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 |
|---|---|---|---|
| * | K933948 | Acufex Endobutton SystemSummary page 1…508) 261-3772 6.4 . Proprietary Name: Pre-Threaded EndoButton Device Name Common Name: Surgical Button Classification Name: Surgical Button 6.5 Predicate EndoButton (K933948), EndoButton Tape (K952535), EndoButton Continuous Legally Loop (K980155) Marketed Smith and Nephew Endoscopy, Inc. Devices Man… | 1994 |
| * | K952535 | Acufex Endobutton TapeSummary page 1…etary Name: Pre-Threaded EndoButton Device Name Common Name: Surgical Button Classification Name: Surgical Button 6.5 Predicate EndoButton (K933948), EndoButton Tape (K952535), EndoButton Continuous Legally Loop (K980155) Marketed Smith and Nephew Endoscopy, Inc. Devices Mansfield, Ma. 6.6 The Pre-Th… | 1996 |
| * | K980155 | Endobutton Continuous LoopSummary page 1…e Common Name: Surgical Button Classification Name: Surgical Button 6.5 Predicate EndoButton (K933948), EndoButton Tape (K952535), EndoButton Continuous Legally Loop (K980155) Marketed Smith and Nephew Endoscopy, Inc. Devices Mansfield, Ma. 6.6 The Pre-Threaded EndoButton is & titanium suture retenti… | 1998 |
What descends from it? (310)
See all 3102 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 7 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K043248 (Arthrex, Inc., 2005) has gone furthest, with 306 descendants of its own.
- 1 other device also cites its predicate K933948.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
The Pre-Threaded EndoButton is used for fixation of tendons and ligaments during orthopedic reconstructive procedures such as Anterior Cruciate Ligament (ACL) Reconstruction
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/K984550 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984550: Pre-Threaded Endobutton.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984550
Report an extraction error
Are you the manufacturer?
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