510(k) · Cleared
ClearedHealix Knotless Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Dec 20, 2011 as substantially equivalent to K112249 (Depuy Mitek, A Johnson & Johnson Company, 2011) and 2 other predicates after a 20-day review. Its family tree reaches back 11 generations to 1997.
- Decided
- Dec 20, 2011
- Review
- 20 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K971358 (1997). 60 ancestors in all, the oldest K930893 (1993). No later device cites it as a predicate yet.
- Root · 11 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 7 generations between
- 3 generations backK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
- 2 generations backK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
- 1 generation backK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011
- This deviceK113534 Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company · 2011
Show all 11 generations
- Root · 11 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 10 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 9 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 8 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 7 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 6 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 5 generations backK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
- 4 generations backK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
- 3 generations backK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
- 2 generations backK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
- 1 generation backK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011
- This deviceK113534 Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −10 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −9 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −8 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −7 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −6 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −5 | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | 1 |
| −4 | K090124 | Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model… | Depuy Mitek, A Johnson & Johnson Company | 2009 | 2 |
| −3 | K100012 | Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
| −2 | K102298 | Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend… | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| −1 | K103712 | Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| 0 (this device) | K113534 | Healix Knotless Anchor | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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 |
|---|---|---|---|
| * | K112249 | Healix Knotless (TM) AnchorSummary page 2…E~EIRi~TAhYNAME Healix KnotlessrM PEEK Anchor SUBSTANTIAL EQUIVALENCE The proposed Healix KnotlessrM Anchor is substantially equivalent to the following devices. * K(112249 DePuy Mitek's Healix KnotlessTm BR Anchor " K(103712 DePuy Mitek's Gryphon PEEK Anchor * K(061863 Arthrex PushLock Ancho… | 2011 |
| * | K103712 | Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordSummary page 1…ePuy Mitek's Healix Knotlessft PEEK Anchor is substantially equivalent to the predicate DePuy Mitek's Healix Knotless M BR Anchor, DePuy Mitek's Gryphon PEEK Anchor (K103712) and Arthrex PushLock Anchor (K061863). * The technological characteristics as it relate to the product design, material sp… | 2011 |
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 1…is substantially equivalent to the predicate DePuy Mitek's Healix Knotless M BR Anchor, DePuy Mitek's Gryphon PEEK Anchor (K103712) and Arthrex PushLock Anchor (K061863). * The technological characteristics as it relate to the product design, material specifications, packaging, indications f… | 2006 |
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 14 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 13 of the 60 ancestors have a recall of any class.
- 2 other devices also cite its predicate K112249.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Healix Knotless™ Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder
* Rotator Cuff
* Biceps Tenodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113534: Healix Knotless Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113534
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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