510(k) · Cleared
ClearedMegaloop Button System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Endophix Co., Ltd. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on May 3, 2024 as substantially equivalent to K110123 (Arthrex, Inc., 2011) and 6 other predicates after a 226-day review. Its family tree reaches back 10 generations to 1979.
- Decided
- May 3, 2024
- Review
- 226 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 10 generations to K792022 (1979). 99 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 6 generations between
- 3 generations backK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007
- 2 generations backK081098 Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
- 1 generation backK130814 Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM…Depuy Mitek, A Johnson & Johnson Company · 2013
- This deviceK232941 Megaloop Button SystemSuzhou Endophix Co., Ltd. · 2024
Show all 10 generations
- Root · 10 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 9 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 8 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 7 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 6 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 5 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 4 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 3 generations backK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007
- 2 generations backK081098 Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
- 1 generation backK130814 Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM…Depuy Mitek, A Johnson & Johnson Company · 2013
- This deviceK232941 Megaloop Button SystemSuzhou Endophix Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −9 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −8 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −7 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −6 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −5 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −4 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −3 | K070780 | Conmed Linvatec XO Button | Conmed Linvatec | 2007 | — |
| −2 | K081098 | Endobutton Continuous Loop (CL) | Smith & Nephew Inc., Endoscopy Division | 2008 | — |
| −1 | K130814 | Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM… | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| 0 (this device) | K232941 | Megaloop Button System | Suzhou Endophix Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 9 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 8 | 0 |
| 2000 | 6 | 0 |
| 2001 | 9 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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? (7)
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 |
|---|---|---|---|
| * | K110123 | PCL TightropeSummary page 5…le, synthetic, polyethylene Classification: Class II, 21 CFR 888.3040, 21 CFR 878.5000 Product Code: HTY, GAT Premarket Notification: K110123 Manufacturer: Arthrex, Inc. Trade Name: ACL TightRope; ACL TigbtRope Double Bundle Common Name… | 2011 |
| * | K112990 | Acl Tightrope,Acl Tightrope Duuble BundleSummary page 6…Page 2 of 16 Classification: Class II, 21 CFR 888.3040 21 CFR 878.5000 Product Code: HTY, GAT Premarket Notification: K112990 Manufacturer: Arthrex, Inc. Trade Name: RIGIDLOOP Cortical Fixation System Common Name: F… | 2011 |
| * | K130814 | Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMSummary page 6…tem Common Name: Fastener, Fixation, Soft Tissue Classification: Class II, 21 CFR 888.3040 Product Code: MBI Premarket Notification: K130814 Manufacturer: Medos International SARL, part of DePuy Mitek, Inc. Trade Name: RIGIDLOOP™ Titanium Butt… | 2013 |
| * | K190774 | RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantSummary page 6…Implant Common Name: Fixation Device Classification: Class II, 21 CFR 888.3040 Product Code: MBI Premarket Notification: K190774 Manufacturer: Medos International SARL, part of DePuy Mitek, Inc. Trade Name: EndoButton Continous Loo… | 2019 |
| * | K980155 | Endobutton Continuous LoopSummary page 6…Polyester Surgical Suture Classification: Class II, 21 CFR 888.3040, 21 CFR 878.5000 Product Code: MBI, GAT Premarket Notification: K980155 Manufacturer: Smith & Nephew, Inc., Endoscopy Division Trade Name: TightRope™ Syndesmosis Device Commo… | 1998 |
| * | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Summary page 6…e™ Syndesmosis Device Common Name: Button/Suture Classification: Class II, 21 CFR 888.3030 Product Code: HTN Premarket Notification: K043248 Manufacturer: Arthrex, Inc. Trade Name: TightRope™ Acromioclavicular (AC) Common Name: Bu… | 2005 |
| * | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Summary page 7…K232941 Page 3 of 16 Product Code: HTN Premarket Notification: K052776 Manufacturer: Arthrex, Inc. Reference device Trade Name: Javelot Ti Suture Anchor, Javelot T… | 2005 |
| † | K232725 | Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 45 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 12 of the 99 ancestors have a recall of any class.
- 1 other device also cites its predicate K110123.
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. 2024, 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?
Megaloop Button System - Megaloop Button with Megaloop Adjustable Loop The device is intended to be used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction. Megaloop Button System - Megaloop AD Device The device is intended to be used for fixation of bone to bone or soft…
Read the full statement (301 words)
Megaloop Button System - Megaloop Button with Megaloop Adjustable Loop
The device is intended to be used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.
Megaloop Button System - Megaloop AD Device
The device is intended to be used for fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.
Megaloop Button System - Megaloop FLB Device, Megaloop FLW Device, Megaloop XL Button
Megaloop FLB Device and Megaloop FLW Device are used for fixation of soft tissue to bone in orthopedic procedures such as ACL repair.
When used in conjunction with the Megaloop FLB Device or Megaloop FLW Device, the Megaloop XL Button is intended for fixation of soft tissue to bone in orthopedic procedures such as ACL repairs.
Megaloop Button System - Megaloop DB Device, Megaloop AC Button with Megaloop Adjustable Loop
The Megaloop DB Device and Megaloop AC Button are intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically:
- The Megaloop DB Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
- The Megaloop AC Button is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
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/K232941 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232941: Megaloop Button System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232941
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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