510(k) · Cleared
ClearedFairFix Adjustable Button System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 26, 2021 as substantially equivalent to K112990 (Arthrex, Inc., 2011) and 1 other predicate after a 141-day review. Its family tree reaches back 9 generations to 1979. 3 later devices descend from it.
- Decided
- Mar 26, 2021
- Review
- 141 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K792022 (1979). 57 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 5 generations between
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007
- 1 generation backK151037 GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation · 2015
- This deviceK203259 FairFix Adjustable Button SystemMedacta International S.A. · 2021
- Descendant · cites it directly · 0 of its ownK223795 FairFix QT Adjustable ButtonMedacta International S.A. · 2023
- Descendant · cites it directly · 0 of its ownK222169 FairFix Adjustable Button SystemMedacta International S.A. · 2022
- Descendant · cites it directly · 0 of its ownK221389 FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A. · 2022
Show all 9 generations
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 7 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 6 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 5 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 4 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007
- 1 generation backK151037 GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleConmed Corporation · 2015
- This deviceK203259 FairFix Adjustable Button SystemMedacta International S.A. · 2021
Most influential descendants
Showing 3 of 3 · See all- K223795FairFix QT Adjustable ButtonMedacta International S.A. · 2023 · cites it directly0descendants
- K222169FairFix Adjustable Button SystemMedacta International S.A. · 2022 · cites it directly0descendants
- K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −8 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −7 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −6 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −5 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −4 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −3 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −2 | K070780 | Conmed Linvatec XO Button | Conmed Linvatec | 2007 | — |
| −1 | K151037 | GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle | Conmed Corporation | 2015 | — |
| 0 (this device) | K203259 | FairFix Adjustable Button System | Medacta International S.A. | 2021 | — |
| +1 | K223795 | FairFix QT Adjustable Button | Medacta International S.A. | 2023 | — |
| +1 | K222169 | FairFix Adjustable Button System | Medacta International S.A. | 2022 | — |
| +1 | K221389 | FairFix AM Adjustable Button FairFix PSP Adjustable Button | Medacta International S.A. | 2022 | — |
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 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K112990 | Acl Tightrope,Acl Tightrope Duuble BundleSummary page 4…mber: 21 CFR 888.3040 Device Classification II I11. Predicate Device Substantial equivalence is claimed to the following devices: Primary Predicate: » ACL TightRope, K112990, Arthrex Inc. Secondary Predicate: » GraftMax Cradle, K151037, Conmed Corporation In addition, the following reference devices… | 2011 |
| * | K151037 | GraftMax Button, ALB with Cradle, GraftMax Button, BTB with CradleSummary page 4…Device Substantial equivalence is claimed to the following devices: Primary Predicate: » ACL TightRope, K112990, Arthrex Inc. Secondary Predicate: » GraftMax Cradle, K151037, Conmed Corporation In addition, the following reference devices are cited within the submission: » OrthoButton AL, K171060, Ri… | 2015 |
| † | K171060 | OrthoButton AL | 2017 |
| † | K171640 | M-ARS ACL: Anatomic Ribbon Surgery System | 2017 |
What descends from it? (3)
3 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 42 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 57 ancestors have a recall of any class.
- Of its descendants, K223795 (Medacta International S.A., 2023) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K112990.
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. 2021, 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?
FairFix Adjustable Button is intended to be used during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5mm tunnel is realized.
FairFix Extender is intended to be used in association with FairFix Adjustable Button during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery with a Ø 6 – 11 mm tunnel.
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/K203259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203259: FairFix Adjustable Button System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203259
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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