510(k) · Cleared
ClearedHealix Knotless (TM) Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Mitek, A Johnson & Johnson Company · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Oct 25, 2011 as substantially equivalent to K061863 (Arthrex, Inc., 2006) and 4 other predicates after an 81-day review. Its family tree reaches back 7 generations to 1997. 13 later devices descend from it.
- Decided
- Oct 25, 2011
- Review
- 81 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K971358 (1997). 29 ancestors in all, the oldest K961555 (1996). 13 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 6 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 5 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 4 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 3 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 2 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 1 generation backK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
- This deviceK112249 Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company · 2011
- Descendant · cites it directly · 9 of its ownK130917 Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2013 · Recalled
- Descendant · cites it directly · 4 of its ownK130539 Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013
- Descendant · 2 generations on · 3 of its ownK131974 Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013
- Descendant · 2 generations on · 3 of its ownK131683 Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013
- Descendant · 2 generations on · 2 of its ownK183501 Parcus Twist AP Suture AnchorsParcus Medical, LLC · 2019
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2013 · cites it directly9descendants
- K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013 · cites it directly4descendants
- K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013 · 2 generations on3descendants
- K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013 · 2 generations on3descendants
- K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −6 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −5 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −4 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −3 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −2 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −1 | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | 1 |
| 0 (this device) | K112249 | Healix Knotless (TM) Anchor | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| +1 | K130917 | Healix Advance Knotless BR Anchor | Depuy Mitek, A Johnson & Johnson Company | 2013 | 2 |
| +1 | K130539 | Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM) | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| +2 | K131974 | Healix Advance Knotless BR Anchor (6.5MM) | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| +2 | K131683 | Healix Advance Knotless Peek Anchor (6.5MM) | Depuy Mitek, Inc., A Johnson and Johnson Company | 2013 | — |
| +2 | K183501 | Parcus Twist AP Suture Anchors | Parcus Medical, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 1…____ Heaix Knotle SST" Anchor SUBSTANTIAL EQUIVALENCE The proposed Healix KnotlessTm Anchor is substantially equivalent to the following devices. " K061863 Arthrex Pushl-ock Anchors " K(073412 DePuy Mitek's Gryphon BR Anchor " K… | 2006 |
| * | K073412 | Gryphon BR and Healix BR AnchorsSummary page 2…g, indications for use and sterilization method; the proposed Healix Knotle SSTM Anchor is substantially equivalent to the predicate DePuy Mitek's Gryphon BR Anchor (K073412). The same absorbable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP) material is used to manufacture both… | 2008 |
| * | K032717 | Biocryl Rapide Interference ScrewSummary page 1…ent to the following devices. " K061863 Arthrex Pushl-ock Anchors " K(073412 DePuy Mitek's Gryphon BR Anchor " K(032717, K(060830 and K(103831 Milagro Interference Screws FDA PRODUCT CODE MAI, HWC DEVICE CLASSIFICATION These types of interfer… | 2004 |
| * | K060830 | Milagro Interference ScrewSummary page 1…following devices. " K061863 Arthrex Pushl-ock Anchors " K(073412 DePuy Mitek's Gryphon BR Anchor " K(032717, K(060830 and K(103831 Milagro Interference Screws FDA PRODUCT CODE MAI, HWC DEVICE CLASSIFICATION These types of interference Screw… | 2006 |
| * | K103831 | Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809Summary page 1…vices. " K061863 Arthrex Pushl-ock Anchors " K(073412 DePuy Mitek's Gryphon BR Anchor " K(032717, K(060830 and K(103831 Milagro Interference Screws FDA PRODUCT CODE MAI, HWC DEVICE CLASSIFICATION These types of interference Screws were origin… | 2011 |
What descends from it? (13)
See all 133 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 14 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 9 of the 29 ancestors have a recall of any class.
- Of its descendants, K130917 (Depuy Mitek, A Johnson & Johnson Company, 2013) has gone furthest, with 9 descendants of its own.
- 33 other devices also cite its predicate K061863.
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. 2011, 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 Knotless™ Anchor is 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/K112249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112249: Healix Knotless (TM) Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112249
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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