510(k) · Cleared
ClearedOrthoButton CL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riverpoint Medical · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jun 3, 2016 as substantially equivalent to K133757 (Parcus Medical, LLC, 2014) after an 87-day review. Its family tree reaches back 11 generations to 1979. 9 later devices descend from it.
- Decided
- Jun 3, 2016
- Review
- 87 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K792022 (1979). 57 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 7 generations between
- 3 generations backK081098 Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
- 2 generations backK090923 Parcus Graft Fixation SystemParcus Medical, LLC · 2009
- 1 generation backK133757 GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC · 2014
- This deviceK160655 OrthoButton CLRiverpoint Medical · 2016
- Descendant · cites it directly · 8 of its ownK171060 OrthoButton ALRiverpoint Medical · 2017
- Descendant · 2 generations on · 2 of its ownK230212 OrthoButton ALRiverpoint Medical, LLC · 2023
- Descendant · 2 generations on · 1 of its ownK240835 Suture Button Repair SystemSkeletal Dynamics, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK202399 OrthoButton FLRiverpoint Medical · 2020
- Descendant · cites it directly · 1 of its ownK191319 Dunamis Fixation Button SystemDunamis, LLC · 2019
Show all 11 generations
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 10 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 9 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 8 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 7 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 6 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 5 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 4 generations backK070780 Conmed Linvatec XO ButtonConmed Linvatec · 2007
- 3 generations backK081098 Endobutton Continuous Loop (CL)Smith & Nephew Inc., Endoscopy Division · 2008
- 2 generations backK090923 Parcus Graft Fixation SystemParcus Medical, LLC · 2009
- 1 generation backK133757 GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC · 2014
- This deviceK160655 OrthoButton CLRiverpoint Medical · 2016
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K171060OrthoButton ALRiverpoint Medical · 2017 · cites it directly8descendants
- K230212OrthoButton ALRiverpoint Medical, LLC · 2023 · 2 generations on2descendants
- K240835Suture Button Repair SystemSkeletal Dynamics, Inc. · 2024 · 2 generations on1descendant
- K202399OrthoButton FLRiverpoint Medical · 2020 · 2 generations on1descendant
- K191319Dunamis Fixation Button SystemDunamis, LLC · 2019 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −10 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −9 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −8 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −7 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −6 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −5 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −4 | K070780 | Conmed Linvatec XO Button | Conmed Linvatec | 2007 | — |
| −3 | K081098 | Endobutton Continuous Loop (CL) | Smith & Nephew Inc., Endoscopy Division | 2008 | — |
| −2 | K090923 | Parcus Graft Fixation System | Parcus Medical, LLC | 2009 | — |
| −1 | K133757 | GFS II Standard, GFS II Large, GFS Mimi | Parcus Medical, LLC | 2014 | — |
| 0 (this device) | K160655 | OrthoButton CL | Riverpoint Medical | 2016 | — |
| +1 | K171060 | OrthoButton AL | Riverpoint Medical | 2017 | — |
| +2 | K230212 | OrthoButton AL | Riverpoint Medical, LLC | 2023 | — |
| +2 | K240835 | Suture Button Repair System | Skeletal Dynamics, Inc. | 2024 | — |
| +2 | K202399 | OrthoButton FL | Riverpoint Medical | 2020 | — |
| +1 | K191319 | Dunamis Fixation Button System | Dunamis, LLC | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K133757 | GFS II Standard, GFS II Large, GFS MimiSummary page 4…Division of Orthopedic Devices (DOD) Joint and Fixation Devices Branch 1 Predicate Devices K133757 – Parcus Medical LLC, GFS Mini. Device Description: The Riverpoint Medical OrthoButton CL is comprised of a braided ultra-high… | 2014 |
What descends from it? (9)
2 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 37 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 57 ancestors have a recall of any class.
- Of its descendants, K171060 (Riverpoint Medical, 2017) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K133757.
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. 2016, 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 Riverpoint Medical OrthoButton CL® is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.
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/K160655 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160655: OrthoButton CL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160655
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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