510(k) · Cleared
ClearedHEALIX ADVANCE SP BIOCOMPOSITE 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 Aug 22, 2019 as substantially equivalent to K101679 (Arthrex, Inc., 2010) and 4 other predicates after a 105-day review. Its family tree reaches back 7 generations to 1996. 2 later devices descend from it.
- Decided
- Aug 22, 2019
- Review
- 105 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K961555 (1996). 12 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 6 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 4 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 3 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 2 generations backK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- 1 generation backK101679 Arthrex Pushlock AnchorsArthrex, Inc. · 2010
- This deviceK191242 HEALIX ADVANCE SP BIOCOMPOSITE AnchorMedos International SARL · 2019
- Descendant · cites it directly · 1 of its ownK201883 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP…Medos International SARL · 2020
- Descendant · cites it directly · 0 of its ownK241010 HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek · 2024
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 |
|---|---|---|---|---|---|
| −7 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −6 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −5 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −4 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −3 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −2 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| −1 | K101679 | Arthrex Pushlock Anchors | Arthrex, Inc. | 2010 | — |
| 0 (this device) | K191242 | HEALIX ADVANCE SP BIOCOMPOSITE Anchor | Medos International SARL | 2019 | — |
| +1 | K201883 | 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite… | Medos International SARL | 2020 | — |
| +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 |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (5)
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 |
|---|---|---|---|
| * | K101679 | Arthrex Pushlock AnchorsSummary page 4…me: Suture Anchor Substantial The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is Equivalence substantially equivalent to: • K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Reference De… | 2010 |
| * | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Summary page 4…e Anchor Substantial The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is Equivalence substantially equivalent to: • K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Reference Devices:… | 2009 |
| * | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…Summary page 4…Substantial The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is Equivalence substantially equivalent to: • K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Reference Devices:… | 2007 |
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 4…ntial The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is Equivalence substantially equivalent to: • K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Reference Devices:… | 2006 |
| * | K051219 | PushlockSummary page 4…The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is Equivalence substantially equivalent to: • K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Reference Devices: •… | 2005 |
| † | K182941 | HEALIX ADVANCE SP PEEK Anchor | 2019 |
| † | K032167 | Bio-Intrafix Tibial Screw and Sheath | 2003 |
| † | K161638 | SPEEDTRAP Graft Preparation System | 2016 |
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 23 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K201883 (Medos International SARL, 2020) has gone furthest, with 1 descendant of its own.
- 20 other devices also cite its predicate K101679.
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. 2019, 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 SP BIOCOMPOSITE Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:
• Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair
• Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral collateral ligament reconstruction, iliotibial (IT) band tenodesis
• Foot/Ankle: Achilles tendon 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/K191242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191242: HEALIX ADVANCE SP BIOCOMPOSITE Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191242
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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