510(k) · Cleared
ClearedY-Knotless™ Flex Anchors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CONMED Corporation · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on May 13, 2026 as substantially equivalent to K253763 (Conmed Corporation, 2026) and 2 other predicates after a 16-day review. Its family tree reaches back 12 generations to 1991.
- Decided
- May 13, 2026
- Review
- 16 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K911837 (1991). 93 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 12 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 8 generations between
- 3 generations backK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- 2 generations backK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013
- 1 generation backK253763 Y-Knotless™ Flex AnchorsConmed Corporation · 2026
- This deviceK261363 Y-Knotless™ Flex AnchorsCONMED Corporation · 2026
Show all 12 generations
- Root · 12 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 11 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 10 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 9 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 8 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 7 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 6 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 5 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 4 generations backK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- 3 generations backK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- 2 generations backK131035 Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures…Linvatec Corporation D/B/A Conmed Linvatec · 2013
- 1 generation backK253763 Y-Knotless™ Flex AnchorsConmed Corporation · 2026
- This deviceK261363 Y-Knotless™ Flex AnchorsCONMED Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −11 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −10 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −9 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −8 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −7 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −6 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −5 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| −4 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
| −3 | K111779 | Y-Knot All-Suture Anchor Model HF13 | Conmed Linvatec | 2011 | — |
| −2 | K131035 | Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MM | Linvatec Corporation D/B/A Conmed Linvatec | 2013 | — |
| −1 | K253763 | Y-Knotless™ Flex Anchors | Conmed Corporation | 2026 | — |
| 0 (this device) | K261363 | Y-Knotless™ Flex Anchors | CONMED Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 8 | 0 |
| 1996 | 13 | 0 |
| 1997 | 12 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K253763 | Y-Knotless™ Flex AnchorsSummary page 5…IMARY PREDICATE/ LEGALLY MARKETED DEVICE Device Name: Y-KnotlessTM Flex Anchors Company Name: CONMED Corporation 510(k) #: K253763 ADDITIONAL PREDICATE DEVICES/ LEGALLY MARKETED DEVICE Device Name: Y-KnotTM All-Suture Anchor Comp… | 2026 |
| * | K111779 | Y-Knot All-Suture Anchor Model HF13Summary page 5…AL PREDICATE DEVICES/ LEGALLY MARKETED DEVICE Device Name: Y-KnotTM All-Suture Anchor Company Name: Conmed Linvatec 510(k) #: K111779 Device Name: Knotilus+ PEEK Knotless Anchor Company Name: Stryker Endoscopy… | 2011 |
| * | K232683 | Knotilus+ PEEK Knotless AnchorSummary page 5…Device Name: Knotilus+ PEEK Knotless Anchor Company Name: Stryker Endoscopy 510(k) #: K232683 IV. DEVICE DESCRIPTION The Y-Knotless™ Flex Anchors are a non-absorbable, all-suture, knotless implant, that are… | 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 35 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 93 ancestors have a recall of any class.
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. 2026, 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 non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.
The Y-Knotless™ Flex Anchors may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone in skeletally mature pediatric and adult patients. The suture anchor systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
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/K261363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261363: Y-Knotless™ Flex Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261363
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026