510(k) Report

510(k) · Cleared

Cleared

Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip, Gryphon Peek Anchor W/ Proknot T

K132241510(k) TraditionalCleared Nov 5, 2013110-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, A Johnson & Johnson Company · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Nov 5, 2013 as substantially equivalent to K121018 (Smith & Nephew, Inc., 2012) and 4 other predicates after a 110-day review. Its family tree reaches back 11 generations to 1997. 1 later device descends from it.

Decided
Nov 5, 2013
Review
110 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
5

Its longest line of descent runs back 11 generations to K971358 (1997). 64 ancestors in all, the oldest K930893 (1993). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2009: 2 other ancestors2008: 4 other ancestors2007: 6 other ancestors2006: 7 other ancestors2001: 6 other ancestors2005: 4 other ancestors2004: 9 other ancestors2003: 1 other ancestor2002: 2 other ancestors1998: 2 other ancestors2000: 3 other ancestors1997: 1 other ancestor1996: 2 other ancestors1994: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor2014: 1 descendant clearedK971358 · 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 · recalledK090124 · Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814 · Depuy Mitek, A Johnson & Johnson Company · 2009 · recalledK100012 · Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS Anchor W/Orthocord, Gryphon P BR a · Depuy Mitek, A Johnson & Johnson Company · 2010×2: 2 generations cleared close together, K102298 (2011), K103712 (2011) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 6 other ancestors3 generations back: 13 other ancestors4 generations back: 14 other ancestors5 generations back: 10 other ancestors6 generations back: 6 other ancestors7 generations back: 2 other ancestors 1 generation forward: 1 descendant K103712 · Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord · Depuy Mitek, A Johnson & Johnson Company · 2011K102298 · Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor W/Orthocord, Healix Transtend · Depuy Mitek, A Johnson & Johnson Company · 2011K100012 · Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS Anchor W/Orthocord, Gryphon P BR a · Depuy Mitek, A Johnson & Johnson Company · 2010K090124 · Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814 · Depuy Mitek, A Johnson & Johnson Company · 2009 · recalledK073412 · 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 · 11 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
  2. 7 generations between
  3. 3 generations backK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
  4. 2 generations backK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
  5. 1 generation backK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011
  6. This deviceK132241 Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/…Depuy Mitek, A Johnson & Johnson Company · 2013
  7. Descendant · cites it directly · 0 of its ownK140643 Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/…Depuy Mitek, A Johnson and Johnson Company · 2014
Show all 11 generations
  1. Root · 11 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
  2. 10 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
  3. 9 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
  4. 8 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
  5. 7 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
  6. 6 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
  7. 5 generations backK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
  8. 4 generations backK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
  9. 3 generations backK100012 Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W…Depuy Mitek, A Johnson & Johnson Company · 2010
  10. 2 generations backK102298 Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2011
  11. 1 generation backK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011
  12. This deviceK132241 Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/…Depuy Mitek, A Johnson & Johnson Company · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K971358Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc.1997—
−10K990454Bio-Interference ScrewInnovasive Devices, Inc.1999—
−9K993975Absolute Absorbable Interference ScrewInnovasive Devices, Inc.1999—
−8K013572Mitek Biocryl Interference ScrewsMitek Products2002—
−7K032717Biocryl Rapide Interference ScrewMitek Worldwide2004—
−6K060830Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company2006—
−5K073412Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company20081
−4K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model…Depuy Mitek, A Johnson & Johnson Company20092
−3K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon…Depuy Mitek, A Johnson & Johnson Company2010—
−2K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend…Depuy Mitek, A Johnson & Johnson Company2011—
−1K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company2011—
0 (this device)K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot…Depuy Mitek, A Johnson & Johnson Company2013—
+1K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
199510
199620
199710
199820
200030
200160
200220
200310
200490
200540
200670
200760
200840
200920
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K132241, 1997–2014Source: 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
*K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an
Summary page 1
…lassified as ClasifictionClass 11, regulated per CFR 888.3040. * Orthopedic panel Predicate * BIORAPTOR6 Knotless Suture Anchor (K 121018, K093428) Device * GRYPHON P BIR Anchor (K090124, K 1000 12) Devce GRYPHON' PEEK Anchor…
Smith & Nephew, Inc.2012—
*K093428Smith & Nephew Knotless Instability Anchor
Summary page 1
…as ClasifictionClass 11, regulated per CFR 888.3040. * Orthopedic panel Predicate * BIORAPTOR6 Knotless Suture Anchor (K 121018, K093428) Device * GRYPHON P BIR Anchor (K090124, K 1000 12) Devce GRYPHON' PEEK Anchor (K 103712…
Smith & Nephew Endoscopy, Inc.2009—
*K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814
Summary page 1
…* Orthopedic panel Predicate * BIORAPTOR6 Knotless Suture Anchor (K 121018, K093428) Device * GRYPHON P BIR Anchor (K090124, K 1000 12) Devce GRYPHON' PEEK Anchor (K 103712) Indiction for Shoulder: Bankart Repair, SLA…
Depuy Mitek, A Johnson & Johnson Company20092
*K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…
Summary page 1
…* Orthopedic panel Predicate * BIORAPTOR6 Knotless Suture Anchor (K 121018, K093428) Device * GRYPHON P BIR Anchor (K090124, K 1000 12) Devce GRYPHON' PEEK Anchor (K 103712) Indiction for Shoulder: Bankart Repair, SLAP Lesion Re…
Depuy Mitek, A Johnson & Johnson Company2010—
*K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord
Summary page 1
…APTOR6 Knotless Suture Anchor (K 121018, K093428) Device * GRYPHON P BIR Anchor (K090124, K 1000 12) Devce GRYPHON' PEEK Anchor (K 103712) Indiction for Shoulder: Bankart Repair, SLAP Lesion Repair. Capsular Shift or Capsulolabral Iniatoseo…
Depuy Mitek, A Johnson & Johnson Company2011—

Also cleared against K121018: 8 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140

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 1.6 years on median.
  • 15 of the 64 ancestors have a recall of any class.
  • Of its descendants, K140643 (Depuy Mitek, A Johnson and Johnson Company, 2014) has gone furthest, with 0 descendants of its own.
  • 8 other devices also cite its predicate K121018.

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. 2013, 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?

GRYPHON ANCHOR wiPROKNOT TECHNOLOGY is indicated for followings.

Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction

Hip: Capsular Repair, Acetabular Labral Repair

Indications for use as stated in the FDA summary.

Also cleared against K121018

8 other devices cite the same predicate.

  • K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P…Suzhou Endophix Co., Ltd. · 2023
  • K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021
  • K182507Tigon Medical Tissue AnchorsTigon Medical · 2019
  • K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC · 2019
  • K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC · 2019
  • K172491ICONN Square 2.5MM Suture AnchorIconn Orthopedics, LLC · 2017

More from Depuy Mitek, A Johnson & Johnson Company

58 FDA decisions under this applicant name. See the company

  • K143660Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2015
  • K1425744.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3…Depuy Mitek, A Johnson & Johnson Company · 2014
  • K140896Vapr Arctic Suction ElectrodeDepuy Mitek, A Johnson & Johnson Company · 2014
  • K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek Anchor with Permacord…Depuy Mitek, A Johnson & Johnson Company · 2014
  • K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix Advance BR Anchor…Depuy Mitek, A Johnson & Johnson Company · 2014

Recent decisions in MAI

The MAI category page

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  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026

https://510kreport.com/device/K132241 · printed Nov 4, 2026

Cite this page

510(k) Report. “K132241: Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip, Gryphon Peek Anchor W/ Proknot T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132241

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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