510(k) · Cleared
ClearedRigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Aug 1, 2013 as substantially equivalent to K980155 (Smith & Nephew, Inc., 1998) and 3 other predicates after a 129-day review. Its family tree reaches back 9 generations to 1979. 3 later devices descend from it.
- Decided
- Aug 1, 2013
- Review
- 129 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K792022 (1979). 59 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 backK081098 Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
- This deviceK130814 Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM…Depuy Mitek, A Johnson & Johnson Company · 2013
- Descendant · cites it directly · 0 of its ownK232941 Megaloop Button SystemSuzhou Endophix Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK232886 INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited · 2023
- Descendant · cites it directly · 0 of its ownK202291 Button LoopYunyi (Beijing) Medical Device Co., Ltd. · 2021
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 backK081098 Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
- This deviceK130814 Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM…Depuy Mitek, A Johnson & Johnson Company · 2013
Most influential descendants
Showing 3 of 3 · See all- K232941Megaloop Button SystemSuzhou Endophix Co., Ltd. · 2024 · cites it directly0descendants
- K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited · 2023 · cites it directly0descendants
- K202291Button LoopYunyi (Beijing) Medical Device Co., Ltd. · 2021 · 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 | K081098 | Endobutton Continuous Loop (CL) | Smith & Nephew Inc., Endoscopy Division | 2008 | — |
| 0 (this device) | K130814 | Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM… | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| +1 | K232941 | Megaloop Button System | Suzhou Endophix Co., Ltd. | 2024 | — |
| +1 | K232886 | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button | Healthium Medtech Limited | 2023 | — |
| +1 | K202291 | Button Loop | Yunyi (Beijing) Medical Device Co., Ltd. | 2021 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980155 | Endobutton Continuous LoopSummary page 1…ommon Name: Fastener, Fixation, Soft Tissue Substantial The RIGIDLOOP Contical Fixation Systemnis substantially equivalent to: Equivalence * K980155 Smith & Nephew EndoButton Continuous Loop * K08 1098 Smith & Nephew EndloBution Continuous Loop… | 1998 |
| * | K081098 | Endobutton Continuous Loop (CL)Summary page 1…The RIGIDLOOP Contical Fixation Systemnis substantially equivalent to: Equivalence * K980155 Smith & Nephew EndoButton Continuous Loop * K08 1098 Smith & Nephew EndloBution Continuous Loop * K060664 Fastin RC Anchors * K040004 / K042398… | 2008 |
| * | K060664 | Fastin RC AnchorSummary page 1…o: Equivalence * K980155 Smith & Nephew EndoButton Continuous Loop * K08 1098 Smith & Nephew EndloBution Continuous Loop * K060664 Fastin RC Anchors * K040004 / K042398 Orthocord suture Device Smooth or threaded metallic bone… | 2006 |
| * | K040004 | Orthocord SutureSummary page 1…w EndoButton Continuous Loop * K08 1098 Smith & Nephew EndloBution Continuous Loop * K060664 Fastin RC Anchors * K040004 / K042398 Orthocord suture Device Smooth or threaded metallic bone fixation fastener, classified as Class 11, prod… | 2004 |
| Kept off the family tree | K042398 | Orthocord suture Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…on Continuous Loop * K08 1098 Smith & Nephew EndloBution Continuous Loop * K060664 Fastin RC Anchors * K040004 / K042398 Orthocord suture Device Smooth or threaded metallic bone fixation fastener, classified as Class 11, product code C… |
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 34 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 59 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.
- 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. 2013, 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 RIGIDLOOPTM Cortical Fixation System is used for the fixation of soft tissue to bone in orthopedic procedures such as ACL repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130814: Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130814
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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