510(k) · Cleared
ClearedRIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jul 25, 2019 as substantially equivalent to K123341 (Arthrex, Inc., 2012) and 1 other predicate after a 121-day review. Its family tree reaches back 9 generations to 1997. 1 later device descends from it.
- Decided
- Jul 25, 2019
- Review
- 121 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K971358 (1997). 85 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 5 generations between
- 3 generations backK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
- 2 generations backK151342 Arthrex SwiveLock AnchorsArthrex, Inc. · 2016
- 1 generation backK173845 Arthrex SwiveLockArthrex, Inc. · 2018
- This deviceK190774 RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL…Medos International SARL · 2019
- Descendant · cites it directly · 0 of its ownK232941 Megaloop Button SystemSuzhou Endophix Co., Ltd. · 2024
Show all 9 generations
- Root · 9 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 8 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 7 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 6 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 5 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 4 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 3 generations backK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
- 2 generations backK151342 Arthrex SwiveLock AnchorsArthrex, Inc. · 2016
- 1 generation backK173845 Arthrex SwiveLockArthrex, Inc. · 2018
- This deviceK190774 RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL…Medos International SARL · 2019
Most influential descendants
Showing 1 of 1 · See all- K232941Megaloop Button SystemSuzhou Endophix Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −8 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −7 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −6 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −5 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −4 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −3 | K071176 | Modification to: Arthrex Interference Screw | Arthrex, Inc. | 2007 | — |
| −2 | K151342 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2016 | — |
| −1 | K173845 | Arthrex SwiveLock | Arthrex, Inc. | 2018 | — |
| 0 (this device) | K190774 | RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant | Medos International SARL | 2019 | — |
| +1 | K232941 | Megaloop Button System | Suzhou Endophix Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 9 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 9 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K123341 | Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Summary page 6…x ARTHREX PEC REPAIR BUTTON, LARGE PEC Equivalence BUTTON, BICEP BUTTON, PROXIMAL BICEPS BUTTON, (Arthrex: K123341) x SWIVELOCK (Arthrex: K173845) REFERENCE DEVICE: x… | 2012 |
| * | K173845 | Arthrex SwiveLockSummary page 6…alence BUTTON, BICEP BUTTON, PROXIMAL BICEPS BUTTON, (Arthrex: K123341) x SWIVELOCK (Arthrex: K173845) REFERENCE DEVICE: x RIGIDLOOP CORTICAL FIXATION SYSTEM, (Depuy… | 2018 |
| † | K130814 | Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232941 | Megaloop Button System | 2024 | 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 22 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 11 of the 85 ancestors have a recall of any class.
- Of its descendants, K232941 (Suzhou Endophix Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K123341.
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. 2019, 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 RIGIDLOOP Titanium Button is intended for fixation of soft-tissue to bone for the following indications when used with PERMATAPE™ 2.5mm Suture, #2 ORTHOCORD® Suture, #2 DYNACORD™ Suture, or equivalent nonabsorbable or partially-absorbable high strength operative suture: Shoulder: Acromioclavicular repair Pectoralis major / minor repair(1) Biceps tenodesis Elbow: Ulnar or radial collateral ligament reconstruction Biceps tendon reattachment Knee…
Read the full statement (209 words)
The RIGIDLOOP Titanium Button is intended for fixation of soft-tissue to bone for the following indications when used with PERMATAPE™ 2.5mm Suture, #2 ORTHOCORD® Suture, #2 DYNACORD™ Suture, or equivalent nonabsorbable or partially-absorbable high strength operative suture:
Shoulder:
Acromioclavicular repair
Pectoralis major / minor repair(1)
Biceps tenodesis
Elbow:
Ulnar or radial collateral ligament reconstruction
Biceps tendon reattachment
Knee:
Cruciate ligament reconstruction (1)
Extracapsular repair: MCL, LCL, and Posterior oblique ligament
Patellar tendon repair
Meniscal root repair(2)
(1) PERMATAPE 2.5mm suture must be used for pectoralis major/minor repair and cruciate ligament reconstruction
(2) Size 0 or size 2/0 ORTHOCORD Suture may be used for meniscal root repair.
RIGIDLOOP™ Cortical Fixation System XL Implant
When used in conjunction with the RIGIDLOOP Cortical Fixation System, the RIGIDLOOP Cortical Fixation System XL Implant is intended for fixation of soft tissue to bone in orthopaedic procedures such as ACL repairs.
When used in conjunction with the RIGIDLOOP Titanium Button, the RIGIDLOOP Cortical Fixation System XL Implant is intended for fixation of soft-tissue to bone for the following indications:
Shoulder:
Pectoralis major / minor repair
Biceps tenodesis
Elbow:
Ulnar or radial collateral ligament reconstruction
Biceps tendon reattachment
Knee:
Cruciate ligament reconstruction
Extracapsular repair: MCL, LCL, and Posterior oblique ligament
Patellar tendon repair
Meniscal root repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190774 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190774: RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190774
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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