510(k) · Cleared
ClearedHealix Advance Knotless Peek Anchor (4.75MM)(5.5MM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on May 21, 2013 as substantially equivalent to K112249 (Depuy Mitek, A Johnson & Johnson Company, 2011) and 2 other predicates after an 81-day review. Its family tree reaches back 8 generations to 1997. 4 later devices descend from it.
- Decided
- May 21, 2013
- Review
- 81 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K971358 (1997). 34 ancestors in all, the oldest K961555 (1996). 4 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 7 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 6 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 5 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 4 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 3 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 2 generations backK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
- 1 generation backK112249 Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company · 2011
- This deviceK130539 Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013
- Descendant · cites it directly · 3 of its ownK131683 Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013
- Descendant · cites it directly · 2 of its ownK171114 HEALIX ADVANCE KNOTLESS AnchorMedos International SARL · 2017
- Descendant · cites it directly · 1 of its ownK180101 HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL · 2018
- Descendant · 2 generations on · 0 of its ownK241010 HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek · 2024
Most influential descendants
Showing 4 of 4 · See all- K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013 · cites it directly3descendants
- K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL · 2017 · cites it directly2descendants
- K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL · 2018 · cites it directly1descendant
- K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −7 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −6 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −5 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −4 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −3 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −2 | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | 1 |
| −1 | K112249 | Healix Knotless (TM) Anchor | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| 0 (this device) | 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 | — |
| +1 | K171114 | HEALIX ADVANCE KNOTLESS Anchor | Medos International SARL | 2017 | — |
| +1 | K180101 | HEALIX ADVANCE KNOTLESS BR Anchor | Medos International SARL | 2018 | — |
| +2 | 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 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K112249 | Healix Knotless (TM) AnchorSummary page 1…cation of Risk Management to Medical Devices PREDICATE DEVICE INFORMATION FPREDICATE DEVICES --- ~ ~ *K 112249 H-ealix Knotless " BR Anchor *K122123 INTRAFIX® PEEK Tapered Screw *K06 1863 Arihrex PushLock PEEK Anchors… | 2011 |
| * | K122123 | 6-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered Screw…Summary page 1…PREDICATE DEVICE INFORMATION FPREDICATE DEVICES --- ~ ~ *K 112249 H-ealix Knotless " BR Anchor *K122123 INTRAFIX® PEEK Tapered Screw *K06 1863 Arihrex PushLock PEEK Anchors Page… | 2012 |
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 1…ICES --- ~ ~ *K 112249 H-ealix Knotless " BR Anchor *K122123 INTRAFIX® PEEK Tapered Screw *K06 1863 Arihrex PushLock PEEK Anchors Page 1/2… | 2006 |
What descends from it? (4)
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 16 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 9 of the 34 ancestors have a recall of any class.
- Of its descendants, K131683 (Depuy Mitek, Inc., A Johnson and Johnson Company, 2013) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K112249.
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. 2013, 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 AdvanceTM Knotless Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder
* Rotator Cuff
* Biceps Tenodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130539: Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130539
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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