510(k) · Cleared
ClearedHEALIX ADVANCE KNOTLESS BR Anchor
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 May 10, 2018 as substantially equivalent to K171114 (Medos International SARL, 2017) and 9 other predicates after a 114-day review. Its family tree reaches back 11 generations to 1997. 1 later device descends from it.
- Decided
- May 10, 2018
- Review
- 114 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 11 generations to K971358 (1997). 45 ancestors in all, the oldest K961555 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 7 generations between
- 3 generations backK130539 Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013
- 2 generations backK131683 Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013
- 1 generation backK171114 HEALIX ADVANCE KNOTLESS AnchorMedos International SARL · 2017
- This deviceK180101 HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL · 2018
- Descendant · cites it directly · 0 of its ownK241010 HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek · 2024
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 backK112249 Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company · 2011
- 3 generations backK130539 Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013
- 2 generations backK131683 Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013
- 1 generation backK171114 HEALIX ADVANCE KNOTLESS AnchorMedos International SARL · 2017
- This deviceK180101 HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL · 2018
Most influential descendants
Showing 1 of 1 · See all- K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek · 2024 · 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 | K112249 | Healix Knotless (TM) Anchor | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| −3 | K130539 | Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM) | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| −2 | K131683 | Healix Advance Knotless Peek Anchor (6.5MM) | Depuy Mitek, Inc., A Johnson and Johnson Company | 2013 | — |
| −1 | K171114 | HEALIX ADVANCE KNOTLESS Anchor | Medos International SARL | 2017 | — |
| 0 (this device) | K180101 | HEALIX ADVANCE KNOTLESS BR Anchor | Medos International SARL | 2018 | — |
| +1 | K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors | Depuy Mitek | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (10)
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 |
|---|---|---|---|
| * | K171114 | HEALIX ADVANCE KNOTLESS AnchorSummary page 4…Common Name: Suture Anchor Substantial The HEALIX ADVANCE KNOTLESS BR Anchor is substantially Equivalence equivalent to: • K171114, K130917, K131974, K130539, K131683 HEALIX ADVANCE KNOTLESS Anchor • K101679, K082810, K0… | 2017 |
| * | K130917 | Healix Advance Knotless BR AnchorSummary page 4…Common Name: Suture Anchor Substantial The HEALIX ADVANCE KNOTLESS BR Anchor is substantially Equivalence equivalent to: • K171114, K130917, K131974, K130539, K131683 HEALIX ADVANCE KNOTLESS Anchor • K101679, K082810, K071177, K0… | 2013 |
| * | K131974 | Healix Advance Knotless BR Anchor (6.5MM)Summary page 4…mon Name: Suture Anchor Substantial The HEALIX ADVANCE KNOTLESS BR Anchor is substantially Equivalence equivalent to: • K171114, K130917, K131974, K130539, K131683 HEALIX ADVANCE KNOTLESS Anchor • K101679, K082810, K071177, K061863, K0… | 2013 |
| * | K130539 | Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Summary page 4…Suture Anchor Substantial The HEALIX ADVANCE KNOTLESS BR Anchor is substantially Equivalence equivalent to: • K171114, K130917, K131974, K130539, K131683 HEALIX ADVANCE KNOTLESS Anchor • K101679, K082810, K071177, K061863, K051219 Art… | 2013 |
| * | K131683 | Healix Advance Knotless Peek Anchor (6.5MM)Summary page 4…nchor Substantial The HEALIX ADVANCE KNOTLESS BR Anchor is substantially Equivalence equivalent to: • K171114, K130917, K131974, K130539, K131683 HEALIX ADVANCE KNOTLESS Anchor • K101679, K082810, K071177, K061863, K051219 Arthrex… | 2013 |
| * | K101679 | Arthrex Pushlock AnchorsSummary page 4…Equivalence equivalent to: • K171114, K130917, K131974, K130539, K131683 HEALIX ADVANCE KNOTLESS Anchor • K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Device HEALIX ADVANCE KNOTLESS BR… | 2010 |
| * | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Summary page 4…ce equivalent to: • K171114, K130917, K131974, K130539, K131683 HEALIX ADVANCE KNOTLESS Anchor • K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Device HEALIX ADVANCE KNOTLESS BR Anchor i… | 2009 |
| * | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…Summary page 4…equivalent to: • K171114, K130917, K131974, K130539, K131683 HEALIX ADVANCE KNOTLESS Anchor • K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Device HEALIX ADVANCE KNOTLESS BR Anchor is classif… | 2007 |
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 4…t to: • K171114, K130917, K131974, K130539, K131683 HEALIX ADVANCE KNOTLESS Anchor • K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Device HEALIX ADVANCE KNOTLESS BR Anchor is classified as: C… | 2006 |
| * | K051219 | PushlockSummary page 4…• K171114, K130917, K131974, K130539, K131683 HEALIX ADVANCE KNOTLESS Anchor • K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Device HEALIX ADVANCE KNOTLESS BR Anchor is classified as: Classifica… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors | 2024 | 0 |
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 2.0 years on median.
- 10 of the 45 ancestors have a recall of any class.
- Of its descendants, K241010 (Depuy Mitek, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K171114.
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 KNOTLESS BR Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder: Rotator Cuff, Biceps Tenodesis, Deltoid Repair
Knee: Posterior Oblique, Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), Iliotibial (IT) Band Tenodesis
Foot/Ankle: Achilles Tendon Repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180101 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180101: HEALIX ADVANCE KNOTLESS BR Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180101
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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