510(k) · Cleared
Cleared4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix Advance BR Anchor, with 2 or 3
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 Feb 4, 2014 as substantially equivalent to K120078 (Depuy Mitek Inc., Johnson and Johnson Company, 2012) and 2 other predicates after a 53-day review. Its family tree reaches back 10 generations to 1997. 8 later devices descend from it.
- Decided
- Feb 4, 2014
- Review
- 53 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K971358 (1997). 29 ancestors in all, the oldest K961555 (1996). 8 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 6 generations between
- 3 generations backK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
- 2 generations backK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
- 1 generation backK120078 Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company · 2012
- This deviceK133794 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord…Depuy Mitek, A Johnson & Johnson Company · 2014
- Descendant · cites it directly · 4 of its ownK173859 HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL · 2018
- Descendant · 2 generations on · 2 of its ownK183506 HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL · 2019
- Descendant · 2 generations on · 1 of its ownK200949 HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL · 2020
- Descendant · cites it directly · 1 of its ownK170639 HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARL · 2017
- Descendant · cites it directly · 1 of its ownK141259 Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with…Depuy Mitek, A Johnson & Johnson Company · 2014
Show all 10 generations
- Root · 10 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 9 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 8 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 7 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 6 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 5 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 4 generations backK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
- 3 generations backK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
- 2 generations backK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
- 1 generation backK120078 Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company · 2012
- This deviceK133794 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord…Depuy Mitek, A Johnson & Johnson Company · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K173859HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL · 2018 · cites it directly4descendants
- K183506HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL · 2019 · 2 generations on2descendants
- K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL · 2020 · 2 generations on1descendant
- K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARL · 2017 · cites it directly1descendant
- K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company · 2014 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −9 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −8 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −7 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −6 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −5 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −4 | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | 1 |
| −3 | K090124 | Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model… | Depuy Mitek, A Johnson & Johnson Company | 2009 | 2 |
| −2 | K100012 | Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
| −1 | K120078 | Healix Advance BR Anchor | Depuy Mitek Inc., Johnson and Johnson Company | 2012 | — |
| 0 (this device) | K133794 | 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture… | Depuy Mitek, A Johnson & Johnson Company | 2014 | — |
| +1 | K173859 | HEALIX ADVANCE Anchor with DYNACORD Suture | Medos International SARL | 2018 | — |
| +2 | K183506 | HEALIX ADVANCE Anchor with DYNACORD Suture | Medos International SARL | 2019 | — |
| +2 | K200949 | HEALIX ADVANCE Anchor with DYNATAPE Suture | Medos International SARL | 2020 | — |
| +1 | K170639 | HEALIX ADVANCE Anchor with PERMATAPE Suture | Medos International SARL | 2017 | — |
| +1 | K141259 | Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon… | Depuy Mitek, A Johnson & Johnson Company | 2014 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K120078 | Healix Advance BR AnchorSummary page 1…Common Name: Suture Anchor Substantial The Healix Advance.. Anchor with Peririacord.. is substantially equivalent to: Equivalence * K 120078 Healix Advance" BR Anchor with Orthrocord* Sutture *K120449 Bealix Advance" PEEK Anchor with Orihocord" suture… | 2012 |
| * | K120449 | Healix Advance Peek AnchorSummary page 1…Advance.. Anchor with Peririacord.. is substantially equivalent to: Equivalence * K 120078 Healix Advance" BR Anchor with Orthrocord* Sutture *K120449 Bealix Advance" PEEK Anchor with Orihocord" suture K100012. K073412 Gryphon"' T BR Anchor with Orthrocord&'… | 2012 |
| * | K100012 | Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Summary page 1…* K 120078 Healix Advance" BR Anchor with Orthrocord* Sutture *K120449 Bealix Advance" PEEK Anchor with Orihocord" suture K100012. K073412 Gryphon"' T BR Anchor with Orthrocord&' suture The following predicate devices were referenced:… | 2010 |
| † | K070673 | Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture | 2007 |
| † | K092533 | Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures | 2009 |
| † | K100506 | Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures… | 2010 |
What descends from it? (8)
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 17 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 10 of the 29 ancestors have a recall of any class.
- Of its descendants, K173859 (Medos International SARL, 2018) has gone furthest, with 4 descendants of its own.
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. 2014, 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 Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;
Hip: Capsular Repair, Acetabular Labral Repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133794: 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix Advance BR Anchor, with 2 or 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133794
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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