510(k) · Cleared
ClearedHEALIX ADVANCE Anchor with DYNACORD Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Apr 11, 2018 as substantially equivalent to K133794 (Depuy Mitek, A Johnson & Johnson Company, 2014) after a 112-day review. Its family tree reaches back 11 generations to 1997. 4 later devices descend from it.
- Decided
- Apr 11, 2018
- Review
- 112 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K971358 (1997). 30 ancestors in all, the oldest K961555 (1996). 4 later devices descend from it, 3 citing it directly.
- 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 backK120078 Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company · 2012
- 1 generation backK133794 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord…Depuy Mitek, A Johnson & Johnson Company · 2014
- This deviceK173859 HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL · 2018
- Descendant · cites it directly · 2 of its ownK183506 HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL · 2019
- Descendant · cites it directly · 1 of its ownK200949 HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL · 2020
- Descendant · 2 generations on · 0 of its ownK203794 HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL · 2021
- Descendant · cites it directly · 0 of its ownK191483 HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMedos International SARL · 2019
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 backK120078 Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company · 2012
- 1 generation backK133794 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord…Depuy Mitek, A Johnson & Johnson Company · 2014
- This deviceK173859 HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL · 2018
Most influential descendants
Showing 4 of 4 · See all- K183506HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL · 2019 · cites it directly2descendants
- K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL · 2020 · cites it directly1descendant
- K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL · 2021 · 2 generations on0descendants
- K191483HEALIX ADVANCE Anchor with DYNA+TAPE SuturesMedos International SARL · 2019 · cites it directly0descendants
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 | K120078 | Healix Advance BR Anchor | Depuy Mitek Inc., Johnson and Johnson Company | 2012 | — |
| −1 | K133794 | 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture… | Depuy Mitek, A Johnson & Johnson Company | 2014 | — |
| 0 (this device) | K173859 | HEALIX ADVANCE Anchor with DYNACORD Suture | Medos International SARL | 2018 | — |
| +1 | K183506 | HEALIX ADVANCE Anchor with DYNACORD Suture | Medos International SARL | 2019 | — |
| +1 | K200949 | HEALIX ADVANCE Anchor with DYNATAPE Suture | Medos International SARL | 2020 | — |
| +2 | K203794 | HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture | Medos International SARL | 2021 | — |
| +1 | K191483 | HEALIX ADVANCE Anchor with DYNA+TAPE Sutures | Medos International SARL | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 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? (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 |
|---|---|---|---|
| * | K133794 | 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…Summary page 4…Suture Anchor Substantial The HEALIX ADVANCE™ Anchor with DYNACORD™ Suture is substantially Equivalence equivalent to: ▪ K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ Suture Reference devices: ▪ K120078/K120449… | 2014 |
| † | K120078 | Healix Advance BR Anchor | 2012 |
| † | K120449 | Healix Advance Peek Anchor | 2012 |
| † | K021434 | Arthrex Fiberwire in Usp Sizes | 2002 |
| † | K041553 | Arthrex Suture Grafting Kit | 2004 |
What descends from it? (4)
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 21 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 10 of the 30 ancestors have a recall of any class.
- Of its descendants, K183506 (Medos International SARL, 2019) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K133794.
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. 2018, 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 ADVANCE Anchor is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows: Shoulder: Rotator Cuff Repair, Bankart.Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair Knee: Medial Collateral Ligament Repair, Lateral…
Read the full statement (84 words)
The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart.Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, [liotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction , Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair
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/K173859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173859: HEALIX ADVANCE Anchor with DYNACORD Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173859
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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