510(k) · Cleared
Cleared6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Aug 7, 2020 as substantially equivalent to K182941 (Medos International SARL, 2019) and 1 other predicate after a 30-day review. Its family tree reaches back 8 generations to 1996. 1 later device descends from it.
- Decided
- Aug 7, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K961555 (1996). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 7 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 6 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 5 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 4 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- 3 generations backK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- 2 generations backK101679 Arthrex Pushlock AnchorsArthrex, Inc. · 2010
- 1 generation backK182941 HEALIX ADVANCE SP PEEK AnchorMedos International SARL · 2019
- This deviceK201883 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 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 |
|---|---|---|---|---|---|
| −8 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −7 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −6 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −5 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −4 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| −3 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| −2 | K101679 | Arthrex Pushlock Anchors | Arthrex, Inc. | 2010 | — |
| −1 | K182941 | HEALIX ADVANCE SP PEEK Anchor | Medos International SARL | 2019 | — |
| 0 (this device) | 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 |
| 2019 | 1 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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? (2)
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 |
|---|---|---|---|
| * | K182941 | HEALIX ADVANCE SP PEEK AnchorSummary page 5…K201883 Substantial The HEALIX ADVANCE SP PEEK Anchor is substantially equivalent Equivalence to: • K182941, HEALIX ADVANCE SP PEEK Anchor The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is substantially equ… | 2019 |
| * | K191242 | HEALIX ADVANCE SP BIOCOMPOSITE AnchorSummary page 5…82941, HEALIX ADVANCE SP PEEK Anchor The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is substantially equivalent to: • K191242, HEALIX ADVANCE SP BIOCOMPOSITE Anchor Device HEALIX ADVANCE SP PEEK Anchor is classified as: Classification Fasten… | 2019 |
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 24 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 14 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 K182941.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The HEALIX ADVANCE SP PEEK 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 The HEALIX ADVANCE SP Biocomposite Anchor is indicated for use in the following…
Read the full statement (104 words)
The HEALIX ADVANCE SP PEEK 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
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 (4.9mm & 5.5mm only)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201883: 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm 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/K201883
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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