510(k) · Cleared
ClearedINFILOOP® Fixed Loop UHMWPE Suture Titanium Button
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthium Medtech Limited · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Nov 8, 2023 as substantially equivalent to K070780 (Conmed Linvatec, 2007) and 1 other predicate after a 51-day review. Its family tree reaches back 10 generations to 1979.
- Decided
- Nov 8, 2023
- Review
- 51 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K792022 (1979). 60 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 deviceK232886 INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited · 2023
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 deviceK232886 INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited · 2023
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) | K232886 | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button | Healthium Medtech Limited | 2023 | — |
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 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2006 | 2 | 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 |
|---|---|---|---|
| * | K070780 | Conmed Linvatec XO ButtonSummary page 5…: Smooth or threaded metallic bone fixation fastener Regulatory Class II Predicate Device Conmed Linvatec XO ButtonTM (Continous Loop) (K070780)-Primary Predicate RIGIDLOOPTM Cortical Fixation System (K130814)-Additional Predicate Referen… | 2007 |
| * | K130814 | Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMSummary page 5…e Device Conmed Linvatec XO ButtonTM (Continous Loop) (K070780)-Primary Predicate RIGIDLOOPTM Cortical Fixation System (K130814)-Additional Predicate Reference Device No reference device used Purpose of Traditional 51… | 2013 |
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 44 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 60 ancestors have a recall of any class.
- 5 other devices also cite its predicate K070780.
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. 2023, 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 INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is indicated in surgical procedures for soft tissue fixation to the bone. It is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Knee ligament reconstruction which includes anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateral ligament (LCL).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232886 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232886: INFILOOP® Fixed Loop UHMWPE Suture Titanium Button.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232886
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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