510(k) · Cleared
ClearedConmed Linvatec XO Button
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Linvatec · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Aug 21, 2007 as substantially equivalent to K980155 (Smith & Nephew, Inc., 1998) and 2 other predicates after a 153-day review. Its family tree reaches back 7 generations to 1979. 38 later devices descend from it.
- Decided
- Aug 21, 2007
- Review
- 153 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K792022 (1979). 53 ancestors in all. 38 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 6 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 5 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 4 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 3 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 2 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 1 generation backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- This deviceK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007
- Descendant · cites it directly · 31 of its ownK081098 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
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K081098Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008 · cites it directly31descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −6 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −5 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −4 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −3 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −2 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −1 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| 0 (this device) | K070780 | Conmed Linvatec XO Button | Conmed Linvatec | 2007 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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? (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 |
|---|---|---|---|
| * | K980155 | Endobutton Continuous LoopSummary page 2…are: Device name: Endobutton Continuous Loop Company name: Smith and Nephew 510(k) #: K980155 Device name: RetroButton Company name: Arthrex 510(k) #:… | 1998 |
| * | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMSummary page 2…k) #: K980155 Device name: RetroButton Company name: Arthrex 510(k) #: K062747 Device name: Tightrope Acromioclavicular (AC) Device Compa… | 2006 |
| * | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Summary page 2…Tightrope Acromioclavicular (AC) Device Company name: Arthrex 510(k) #: K052776 E. Device Description The ConMed Linvatec XO ButtonTM is a sterile, single use, implant for fixation of soft tissue to bon… | 2005 |
What descends from it? (38)
See all 386 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081098 | Endobutton Continuous Loop (CL) | 2008 | 31 |
| K090923 | Parcus Graft Fixation System | 2009 | 21 |
| K151037 | GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle | 2015 | 5 |
| K101616 | The Grapplr and Grapplr Extender | 2011 | 1 |
| K232886 | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button | 2023 | 0 |
| K191204 | Infinity Fixation System | 2019 | 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 28 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 53 ancestors have a recall of any class.
- Of its descendants, K081098 (Smith & Nephew Inc., Endoscopy Division, 2008) has gone furthest, with 31 descendants of its own.
- 13 other devices also cite its predicate K980155.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The XO Button without continuos loop is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or reconstruction of a ligament using soft tissue grafts or bone tendon grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, lateral collateral ligament, distal biceps tendon rupture, and separations due to…
Read the full statement (122 words)
The XO Button without continuos loop is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or reconstruction of a ligament using soft tissue grafts or bone tendon grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, lateral collateral ligament, distal biceps tendon rupture, and separations due to coracoclavicular ligament disruptions.
The XO Button with continuos loop is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or reconstruction of a ligament using soft tissue grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, and lateral collateral ligament.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070780 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070780: Conmed Linvatec XO Button.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070780
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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