510(k) · Cleared
Recalled · 2011Gryphon BR and Healix BR Anchors
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 Jan 17, 2008 as substantially equivalent to K071481 (Depuy Mitek, A Johnson & Johnson Company, 2007) and 4 other predicates after a 44-day review. Its family tree reaches back 6 generations to 1997. 44 later devices descend from it. It has been recalled once.
- Decided
- Jan 17, 2008
- Review
- 44 days
- Class
- Class II
- Product code
- MAI
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 6 generations to K971358 (1997). 24 ancestors in all, the oldest K961555 (1996). 44 later devices descend from it, 10 citing it directly.
- Root · 6 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 5 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 4 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 3 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 2 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 1 generation backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- This deviceK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008
- Descendant · cites it directly · 25 of its ownK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
- Descendant · cites it directly · 24 of its ownK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
- Descendant · cites it directly · 15 of its ownK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
- Descendant · cites it directly · 13 of its ownK112249 Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company · 2011
- Descendant · 2 generations on · 9 of its ownK130917 Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2013 · Recalled
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company · 2009 · cites it directly25descendants
- K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Depuy Mitek, A Johnson & Johnson Company · 2010 · cites it directly24descendants
- K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company · 2011 · cites it directly15descendants
- K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company · 2011 · cites it directly13descendants
- K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2013 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −5 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −4 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −3 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −2 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −1 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| 0 (this device) | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | — |
| +1 | K090124 | Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model… | Depuy Mitek, A Johnson & Johnson Company | 2009 | 2 |
| +1 | K100012 | Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon… | Depuy Mitek, A Johnson & Johnson Company | 2010 | — |
| +1 | K102298 | Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend… | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| +1 | K112249 | Healix Knotless (TM) Anchor | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| +2 | K130917 | Healix Advance Knotless BR Anchor | Depuy Mitek, A Johnson & Johnson Company | 2013 | 2 |
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 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K071481 | Healix AnchorSummary page 1…nd Gryphon BR Anchor Substantial Equivalence Healix BR and Gryphon BR Anchors are substantially equivalent to: Mitek Healix PEEK Anchor (K071481); BioKnotless/Lupine BR Anchors (K070925), the Arthrex Biocomposite Suture Anchor Family… | 2007 |
| * | K070925 | Modification to: Bioknotless BR Anchor / Lupine BR AnchorSummary page 1…hon BR Anchors are substantially equivalent to: Mitek Healix PEEK Anchor (K071481); BioKnotless/Lupine BR Anchors (K070925), the Arthrex Biocomposite Suture Anchor Family (K071177), and the Milagro Interference Screws (K03271… | 2007 |
| * | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…Summary page 1…alix PEEK Anchor (K071481); BioKnotless/Lupine BR Anchors (K070925), the Arthrex Biocomposite Suture Anchor Family (K071177), and the Milagro Interference Screws (K03271 7 and K060830). Device Classification This devic… | 2007 |
| * | K032717 | Biocryl Rapide Interference ScrewSummary page 1…BR Anchors (K070925), the Arthrex Biocomposite Suture Anchor Family (K071177), and the Milagro Interference Screws (K03271 7 and K060830). Device Classification This device carries an FDA product code MAI, and subsequen… | 2004 |
| * | K060830 | Milagro Interference ScrewSummary page 1…070925), the Arthrex Biocomposite Suture Anchor Family (K071177), and the Milagro Interference Screws (K03271 7 and K060830). Device Classification This device carries an FDA product code MAI, and subsequent product c… | 2006 |
What descends from it? (44)
See all 4410 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090124 | Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814 | 2009 | 25 |
| K100012 | Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS… | 2010 | 24 |
| K102298 | Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor… | 2011 | 15 |
| K112249 | Healix Knotless (TM) Anchor | 2011 | 13 |
| K120078 | Healix Advance BR Anchor | 2012 | 9 |
| K103712 | Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord | 2011 | 6 |
| K171299 | Fixone Biocomposite Anchor | 2017 | 4 |
| K183501 | Parcus Twist AP Suture Anchors | 2019 | 2 |
| K170639 | HEALIX ADVANCE Anchor with PERMATAPE Suture | 2017 | 1 |
| K243790 | GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 24, 2011 | Not classified | Z-2208-2011 | Manufacturing material removal | Metal debris in the shaft component of the device |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 8 of the 24 ancestors have a recall of any class.
- Of its descendants, K090124 (Depuy Mitek, A Johnson & Johnson Company, 2009) has gone furthest, with 25 descendants of its own.
- 5 other devices also cite its predicate K071481.
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. 2008, 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?
Gryphon BR Anchor is indicated for use in the following: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band…
Read the full statement (130 words)
Gryphon BR Anchor is indicated for use in the following:
Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Healix BR Anchor is indicated for use in the following:
Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073412 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073412: Gryphon BR and Healix BR Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073412
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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