510(k) Report

510(k) · Cleared

Cleared

HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors

K241010510(k) SpecialCleared Sep 11, 2024152-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Depuy Mitek · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Sep 11, 2024 as substantially equivalent to K180101 (Medos International SARL, 2018) and 4 other predicates after a 152-day review. Its family tree reaches back 12 generations to 1997.

Decided
Sep 11, 2024
Review
152 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
5

Its longest line of descent runs back 12 generations to K971358 (1997). 49 ancestors in all, the oldest K961555 (1996). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2020: 1 other ancestor2019: 2 other ancestors2013: 2 other ancestors2010: 1 other ancestor2009: 2 other ancestors2007: 4 other ancestors2006: 4 other ancestors2005: 3 other ancestors2012: 1 other ancestor2000: 3 other ancestors1997: 1 other ancestor2011: 1 other ancestor2003: 2 other ancestors1999: 1 other ancestor1998: 1 other ancestor2004: 3 other ancestors2002: 2 other ancestors2001: 2 other ancestors1996: 1 other ancestorK971358 · Bio-Interference Screw, 7 MM, 8 MM, 9 MM · Arthrex, Inc. · 1997K990454 · Bio-Interference Screw · Innovasive Devices, Inc. · 1999K993975 · Absolute Absorbable Interference Screw · Innovasive Devices, Inc. · 1999K013572 · Mitek Biocryl Interference Screws · Mitek Products · 2002K032717 · Biocryl Rapide Interference Screw · Mitek Worldwide · 2004K060830 · Milagro Interference Screw · Depuy Mitek, A Johnson & Johnson Company · 2006K073412 · Gryphon BR and Healix BR Anchors · Depuy Mitek, A Johnson & Johnson Company · 2008 · recalledK112249 · Healix Knotless (TM) Anchor · Depuy Mitek, A Johnson & Johnson Company · 2011×2: 2 generations cleared close together, K130539 (2013), K131683 (2013) K171114 · HEALIX ADVANCE KNOTLESS Anchor · Medos International SARL · 2017K180101 · HEALIX ADVANCE KNOTLESS BR Anchor · Medos International SARL · 20181995200020052010201520202025
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 7 other ancestors3 generations back: 5 other ancestors4 generations back: 5 other ancestors5 generations back: 8 other ancestors6 generations back: 5 other ancestors7 generations back: 3 other ancestors8 generations back: 1 other ancestor K180101 · HEALIX ADVANCE KNOTLESS BR Anchor · Medos International SARL · 2018K171114 · HEALIX ADVANCE KNOTLESS Anchor · Medos International SARL · 2017K131683 · Healix Advance Knotless Peek Anchor (6.5MM) · Depuy Mitek, Inc., A Johnson and Johnson Company · 2013K130539 · Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM) · Depuy Mitek, A Johnson & Johnson Company · 2013K112249 · Healix Knotless (TM) Anchor · Depuy Mitek, A Johnson & Johnson Company · 2011K073412 · Gryphon BR and Healix BR Anchors · Depuy Mitek, A Johnson & Johnson Company · 2008 · recalledK060830 · Milagro Interference Screw · Depuy Mitek, A Johnson & Johnson Company · 2006K032717 · Biocryl Rapide Interference Screw · Mitek Worldwide · 2004K013572 · Mitek Biocryl Interference Screws · Mitek Products · 2002K993975 · Absolute Absorbable Interference Screw · Innovasive Devices, Inc. · 1999K990454 · Bio-Interference Screw · Innovasive Devices, Inc. · 1999K971358 · Bio-Interference Screw, 7 MM, 8 MM, 9 MM · Arthrex, Inc. · 1997−10−50
  1. Root · 12 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
  2. 8 generations between
  3. 3 generations backK131683 Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013
  4. 2 generations backK171114 HEALIX ADVANCE KNOTLESS AnchorMedos International SARL · 2017
  5. 1 generation backK180101 HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL · 2018
  6. This deviceK241010 HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek · 2024
Show all 12 generations
  1. Root · 12 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
  2. 11 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
  3. 10 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
  4. 9 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
  5. 8 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
  6. 7 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
  7. 6 generations backK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
  8. 5 generations backK112249 Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company · 2011
  9. 4 generations backK130539 Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013
  10. 3 generations backK131683 Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013
  11. 2 generations backK171114 HEALIX ADVANCE KNOTLESS AnchorMedos International SARL · 2017
  12. 1 generation backK180101 HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL · 2018
  13. This deviceK241010 HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K971358Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc.1997—
−11K990454Bio-Interference ScrewInnovasive Devices, Inc.1999—
−10K993975Absolute Absorbable Interference ScrewInnovasive Devices, Inc.1999—
−9K013572Mitek Biocryl Interference ScrewsMitek Products2002—
−8K032717Biocryl Rapide Interference ScrewMitek Worldwide2004—
−7K060830Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company2006—
−6K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company20081
−5K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company2011—
−4K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company2013—
−3K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company2013—
−2K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL2017—
−1K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL2018—
0 (this device)K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199810
199910
200030
200120
200220
200320
200430
200530
200640
200740
200920
201010
201110
201210
201320
201920
202010
FIG. 1 — Lineage of K241010, 1997–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K180101HEALIX ADVANCE KNOTLESS BR Anchor
Summary page 7
…K241010 Substantial The HEALIX ADVANCE Knotless BR anchors are substantially equivalent to Equivalence predicate: • K180101 HEALIX ADVANCE Knotless BR The HEALIX ADVANCE Knotless PEEK anchors are substantially equivalent to…
Medos International SARL2018—
*K171114HEALIX ADVANCE KNOTLESS Anchor
Summary page 7
…HEALIX ADVANCE Knotless BR The HEALIX ADVANCE Knotless PEEK anchors are substantially equivalent to predicate: • K171114 HEALIX ADVANCE Knotless PEEK The HEALIX ADVANCE Self-Punching Biocomposite anchors (4.9mm, 5.5mm…
Medos International SARL2017—
*K191242HEALIX ADVANCE SP BIOCOMPOSITE Anchor
Summary page 7
…The HEALIX ADVANCE Self-Punching Biocomposite anchors (4.9mm, 5.5mm lengths) are substantially equivalent to predicate: • K191242 HEALIX ADVANCE Self-Punching Biocomposite anchors (4.9mm, 5.5mm lengths) The HEALIX AD…
Medos International SARL2019—
*K182941HEALIX ADVANCE SP PEEK Anchor
Summary page 7
…The HEALIX ADVANCE Self-Punching PEEK anchors (4.9mm, 5.5mm lengths) are substantially equivalent to predicate: • K182941 HEALIX ADVANCE Self-Punching PEEK anchors (4.9mm, 5.5mm lengths) The HEALIX ADVANCE Se…
Medos International SARL2019—
*K2018836.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor
Summary page 7
…The HEALIX ADVANCE Self-Punching PEEK & Biocomposite anchors 6.5mm lengths) are substantially equivalent to predicate: • K201883 HEALIX ADVANCE Self-Punching PEEK & Biocomposite anchors (6.5mm lengths) Device HEALIX ADVAN…
Medos International SARL2020—

What descends from it?

No later submission names this one as a predicate yet.

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 27 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
  • 10 of the 49 ancestors have a recall of any class.

How does its category compare?

All MAI devices

MAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · MAI

8in 2025

2007: 42008: 32009: 92010: 42011: 92012: 62013: 62014: 42015: 52016: 32017: 92018: 132019: 92020: 92021: 82022: 62023: 82024: 72025: 82026 (partial year): 5
2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007: 100 days median2008: 83 days median2009: 74 days median2010: 122 days median2011: 90 days median2012: 56 days median2013: 135 days median2014: 86 days median2015: 95 days median2016: 191 days median2017: 113 days median2018: 108 days median2019: 41 days median2020: 78 days median2021: 115 days median2022: 136 days median2023: 34 days median2024: 53 days median2025: 54 days median2026 (partial year): 69 days median
2007high 191 (2016) · low 34 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAI

40in 2020

2011: 52012: 102019: 22020: 402026 (partial year): 1
2007high 40 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MAI

2,148in 2025

2007: 2722008: 1722009: 882010: 892011: 1292012: 1712013: 1662014: 1492015: 1822016: 3012017: 4782018: 1,5902019: 1,2482020: 9572021: 1,2672022: 1,4252023: 1,7182024: 2,3002025: 2,148
2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200741000272
20083830172
2009974088
20104122089
20119905129
201265610171
201361350166
20144860149
20155950182
201631910301
201791130478
20181310801,590
201994121,248
202097840957
2021811501,267
2022613601,425
202383401,718
202475302,300
202585402,148
20265691—

What is it indicated for?

The DePuy Mitek HEALIX ADVANCE Knotless BR anchors is indicated as follows: * Shoulder: Rotator Cuff Repair * Shoulder: Bicep Tenodesis * Shoulder: Deltoid Repair * Elbow: Ulnar Collateral Ligament (UCL) * Elbow: Radial Collateral Ligament (RCL) * Knee: Posterior Oblique * Knee: Medial Collateral Ligament (MCL) * Knee: Lateral Collateral Ligament (LCL) * Knee: liotibial (IT) Band Tenodesis * Knee: Anterior Cruciate Ligament (ACL) Repair * Knee: Secondary…

Read the full statement (357 words)

The DePuy Mitek HEALIX ADVANCE Knotless BR anchors is indicated as follows:

* Shoulder: Rotator Cuff Repair

* Shoulder: Bicep Tenodesis

* Shoulder: Deltoid Repair

* Elbow: Ulnar Collateral Ligament (UCL)

* Elbow: Radial Collateral Ligament (RCL)

* Knee: Posterior Oblique

* Knee: Medial Collateral Ligament (MCL)

* Knee: Lateral Collateral Ligament (LCL)

* Knee: liotibial (IT) Band Tenodesis

* Knee: Anterior Cruciate Ligament (ACL) Repair

* Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair

* Knee: Meniscal Root Repair

* Foot and Ankle: Achilles Tendon Repair

The DePuy Mitek HEALIX ADVANCE KNOTLESS PEEK Anchors is indicated as follows:

* Shoulder: Rotator Cuff Repair

* Shoulder: Bicep Tenodesis

* Shoulder: Deltoid Repair

* Elbow: Ulnar Collateral Ligament (UCL)

* Elbow: Radial Collateral Ligament (RCL)

* Knee: Posterior Oblique

* Knee: Medial Collateral Ligament (MCL)

* Knee: Lateral Collateral Ligament (LCL)

* Knee: liotibial (IT) Band Tenodesis

* Knee: Anterior Cruciate Ligament (ACL) Repair

* Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair

* Knee: Meniscal Root Repair

* Foot and Ankle: Achilles Tendon Repair

* Foot and Ankle: Lateral Stabilization

* Foot and Ankle: Medial Stabilization

The DePuy Mitek HEALIX ADVANCE SP Biocomposite Anchors is indicated as follows:

* Shoulder: Rotator Cuff Repair

* Shoulder: Bicep Tenodesis

* Shoulder: Deltoid Repair

* Elbow: Ulnar Collateral Ligament (UCL)

* Elbow: Radial Collateral Ligament (RCL)

* Knee: Posterior Oblique

* Knee: Medial Collateral Ligament (MCL)

* Knee: Lateral Collateral Ligament (LCL)

* Knee: liotibial (IT) Band Tenodesis

* Knee: Anterior Cruciate Ligament (ACL) Repair

* Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair

* Knee: Meniscal Root Repair

The DePuy Mitek HEALIX ADVANCE SP PEEK Anchors is indicated as follows:

* Shoulder: Rotator Cuff Repair

* Shoulder: Bicep Tenodesis

* Shoulder: Deltoid Repair

* Elbow: Ulnar Collateral Ligament (UCL)

* Elbow: Radial Collateral Ligament (RCL)

* Knee: Posterior Oblique

* Knee: Medial Collateral Ligament (MCL)

* Knee: Lateral Collateral Ligament (LCL)

* Knee: liotibial (IT) Band Tenodesis

* Knee: Anterior Cruciate Ligament (ACL) Repair

* Knee: Secondary Fixation in ACL/PCL Reconstruction/Repair

* Knee: Meniscal Root Repair

* Foot and Ankle: Achilles Tendon Repair

* Foot and Ankle: Lateral Stabilization

* Foot and Ankle: Medial Stabilization

Indications for use as stated in the FDA summary.

More from Depuy Mitek

13 FDA decisions under this applicant name. See the company

  • K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek · 2025
  • K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek · 2024
  • K143475VAPR Tripolar Suction ElectrodeDepuy Mitek · 20151 recall
  • K120449Healix Advance Peek AnchorDepuy Mitek · 2012
  • K080918Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet & 3 Free Strands of…Depuy Mitek · 2008

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https://510kreport.com/device/K241010 · printed Nov 6, 2026

Cite this page

510(k) Report. “K241010: HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241010

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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