510(k) · Cleared

Cleared

Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS Anchor W/Orthocord, Gryphon P BR a

K100012510(k) TraditionalCleared Apr 30, 2010116-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 Apr 30, 2010 as substantially equivalent to K090124 (Depuy Mitek, A Johnson & Johnson Company, 2009) and 1 other predicate after a 116-day review. Its family tree reaches back 8 generations to 1997. 24 later devices descend from it.

Decided: Apr 30, 2010
Review: 116 days
Class: Class II
Product code: MAI
Recalls: None
Predicates: 2

Its longest line of descent runs back 8 generations to K971358 (1997). 26 ancestors in all, the oldest K961555 (1996). 24 later devices descend from it, 8 citing it directly.

By dateBy generation

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 backK090124 Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord…Depuy Mitek, A Johnson & Johnson Company · 2009 · Recalled
This deviceK100012 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 · 9 of its ownK120078 Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company · 2012
Descendant · cites it directly · 8 of its ownK133794 4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord…Depuy Mitek, A Johnson & Johnson Company · 2014
Descendant · 2 generations on · 6 of its ownK211002 Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · Recalled
Descendant · cites it directly · 6 of its ownK103712 Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2011high 3 (2011) · low 0 (2015)2026

Most influential descendants

Showing 5 of 24 · See all

K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company · 2011 · cites it directly15descendants
K120078Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company · 2012 · cites it directly9descendants
K1337944.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…Depuy Mitek, A Johnson & Johnson Company · 2014 · cites it directly8descendants
K211002Grappler Suture Anchor SystemParagon 28, Inc. · 2021 · 2 generations on6descendants
K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company · 2011 · cites it directly6descendants

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	K090124	Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model…	Depuy Mitek, A Johnson & Johnson Company	2009	2
0 (this device)	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	K120078	Healix Advance BR Anchor	Depuy Mitek Inc., Johnson and Johnson Company	2012	—
+1	K133794	4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture…	Depuy Mitek, A Johnson & Johnson Company	2014	—
+2	K211002	Grappler Suture Anchor System	Paragon 28, Inc.	2021	1
+1	K103712	Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord	Depuy Mitek, A Johnson & Johnson Company	2011	—

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
2011	3	0
2012	1	0
2013	2	0
2014	3	0
2017	1	0
2018	2	0
2019	2	0
2020	1	0
2021	2	0
2022	1	0
2023	2	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K100012, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K090124	Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814 Summary page 1 …e The proposed Gryphon T and P HR Anchors are substantially equivalent to: * K090124 Gryphon P BR Anchor (March II, 2009); * K073412 Gryphon BR and Healix BR Anchors (January…	Depuy Mitek, A Johnson & Johnson Company	2009	2
*	K073412	Gryphon BR and Healix BR Anchors Summary page 1 …equivalent to: * K090124 Gryphon P BR Anchor (March II, 2009); * K073412 Gryphon BR and Healix BR Anchors (January 17, 2008). The proposed Gryphon T and P BR Ancho…	Depuy Mitek, A Johnson & Johnson Company	2008	1

Also cleared against K090124: 6 other devices →

What descends from it? (24)

See all 24

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K102298	Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…	Depuy Mitek, A Johnson & Johnson Company	2011	15
K120078	Healix Advance BR Anchor	Depuy Mitek Inc., Johnson and Johnson Company	2012	9
K133794	4.5MM Healix Advance BR Anchor, with 2 or 3 Strands of #2 Permacord Suture, 5.5MM Healix…	Depuy Mitek, A Johnson & Johnson Company	2014	8
K103712	Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord	Depuy Mitek, A Johnson & Johnson Company	2011	6
K170639	HEALIX ADVANCE Anchor with PERMATAPE Suture	Medos International SARL	2017	1
K141259	Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…	Depuy Mitek, A Johnson & Johnson Company	2014	1
K132241	Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…	Depuy Mitek, A Johnson & Johnson Company	2013	1
K140643	Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot Technology	Depuy Mitek, A Johnson and Johnson Company	2014	0

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 13 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
10 of the 26 ancestors have a recall of any class.
Of its descendants, K102298 (Depuy Mitek, A Johnson & Johnson Company, 2011) has gone furthest, with 15 descendants of its own.
6 other devices also cite its predicate K090124.

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. 2010, this device’s year, is highlighted.

FDA decisions per year · MAI

8in 2025

2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

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

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

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?

Shoulder: Rotator 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;

Hip: Capsular repair, acetabular labral repair.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100012 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100012: Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS Anchor W/Orthocord, Gryphon P BR a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100012

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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