510(k) · Cleared
ClearedHEALIX ADVANCE KNOTLESS 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 Nov 27, 2017 as substantially equivalent to K130917 (Depuy Mitek, A Johnson & Johnson Company, 2013) and 8 other predicates after a 227-day review. Its family tree reaches back 10 generations to 1997. 2 later devices descend from it.
- Decided
- Nov 27, 2017
- Review
- 227 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 10 generations to K971358 (1997). 44 ancestors in all, the oldest K961555 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 6 generations between
- 3 generations backK112249 Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company · 2011
- 2 generations backK130539 Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013
- 1 generation backK131683 Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013
- This deviceK171114 HEALIX ADVANCE KNOTLESS AnchorMedos International SARL · 2017
- Descendant · cites it directly · 1 of its ownK180101 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 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 backK112249 Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company · 2011
- 2 generations backK130539 Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013
- 1 generation backK131683 Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013
- This deviceK171114 HEALIX ADVANCE KNOTLESS AnchorMedos International SARL · 2017
Most influential descendants
Showing 2 of 2 · See allView 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 | K112249 | Healix Knotless (TM) Anchor | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| −2 | K130539 | Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM) | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| −1 | K131683 | Healix Advance Knotless Peek Anchor (6.5MM) | Depuy Mitek, Inc., A Johnson and Johnson Company | 2013 | — |
| 0 (this device) | K171114 | HEALIX ADVANCE KNOTLESS Anchor | Medos International SARL | 2017 | — |
| +1 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 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? (9)
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 |
|---|---|---|---|
| * | K130917 | Healix Advance Knotless BR AnchorSummary page 5…ers Common Name: Suture Anchor Substantial The HEALIX ADVANCE™ KNOTLESS Anchor is substantially equivalent to: Equivalence ▪ K130917, K131974 HEALIX ADVANCE™ KNOTLESS BR Anchor ▪ K130539, K131683 HEALIX ADVANCE™ KNOTLESS PEEK Anchor… | 2013 |
| * | K131974 | Healix Advance Knotless BR Anchor (6.5MM)Summary page 5…Common Name: Suture Anchor Substantial The HEALIX ADVANCE™ KNOTLESS Anchor is substantially equivalent to: Equivalence ▪ K130917, K131974 HEALIX ADVANCE™ KNOTLESS BR Anchor ▪ K130539, K131683 HEALIX ADVANCE™ KNOTLESS PEEK Anchor… | 2013 |
| * | K130539 | Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Summary page 5…The HEALIX ADVANCE™ KNOTLESS Anchor is substantially equivalent to: Equivalence ▪ K130917, K131974 HEALIX ADVANCE™ KNOTLESS BR Anchor ▪ K130539, K131683 HEALIX ADVANCE™ KNOTLESS PEEK Anchor ▪ K101679, K082810, K071177, K061863, K051219 Arthrex PushLock… | 2013 |
| * | K131683 | Healix Advance Knotless Peek Anchor (6.5MM)Summary page 5…HEALIX ADVANCE™ KNOTLESS Anchor is substantially equivalent to: Equivalence ▪ K130917, K131974 HEALIX ADVANCE™ KNOTLESS BR Anchor ▪ K130539, K131683 HEALIX ADVANCE™ KNOTLESS PEEK Anchor ▪ K101679, K082810, K071177, K061863, K051219 Arthrex PushLock… | 2013 |
| * | K101679 | Arthrex Pushlock AnchorsSummary page 5…uivalence ▪ K130917, K131974 HEALIX ADVANCE™ KNOTLESS BR Anchor ▪ K130539, K131683 HEALIX ADVANCE™ KNOTLESS PEEK Anchor ▪ K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Device ➢ HEALIX ADVANCE™ KNOTLESS… | 2010 |
| * | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Summary page 5…▪ K130917, K131974 HEALIX ADVANCE™ KNOTLESS BR Anchor ▪ K130539, K131683 HEALIX ADVANCE™ KNOTLESS PEEK Anchor ▪ K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Device ➢ HEALIX ADVANCE™ KNOTLESS BR Ancho… | 2009 |
| * | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…Summary page 5…▪ K130917, K131974 HEALIX ADVANCE™ KNOTLESS BR Anchor ▪ K130539, K131683 HEALIX ADVANCE™ KNOTLESS PEEK Anchor ▪ K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Device ➢ HEALIX ADVANCE™ KNOTLESS BR Anchor is clas… | 2007 |
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 5…, K131974 HEALIX ADVANCE™ KNOTLESS BR Anchor ▪ K130539, K131683 HEALIX ADVANCE™ KNOTLESS PEEK Anchor ▪ K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Device ➢ HEALIX ADVANCE™ KNOTLESS BR Anchor is classified as… | 2006 |
| * | K051219 | PushlockSummary page 5…HEALIX ADVANCE™ KNOTLESS BR Anchor ▪ K130539, K131683 HEALIX ADVANCE™ KNOTLESS PEEK Anchor ▪ K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Device ➢ HEALIX ADVANCE™ KNOTLESS BR Anchor is classified as: Classif… | 2005 |
What descends from it? (2)
2 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 20 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 10 of the 44 ancestors have a recall of any class.
- Of its descendants, K180101 (Medos International SARL, 2018) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K130917.
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. 2017, 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 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
*HEALIX ADVANCE KNOTLESS PEEK Anchors only
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/K171114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171114: HEALIX ADVANCE 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/K171114
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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