510(k) · Cleared

Cleared

2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor

K232492510(k) TraditionalCleared Oct 6, 202350-day reviewClass II21 CFR 888.3040

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

Medos International SARL · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Oct 6, 2023 as substantially equivalent to K101679 (Arthrex, Inc., 2010) after a 50-day review. Its family tree reaches back 7 generations to 1996.

Decided: Oct 6, 2023
Review: 50 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 7 generations to K961555 (1996). 9 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 7 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
6 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
5 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
4 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
3 generations backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
2 generations backK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
1 generation backK101679 Arthrex Pushlock AnchorsArthrex, Inc. · 2010
This deviceK232492 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex…Medos International SARL · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K961555	Acufex Tag Bioabsorbable Anchors	Acufex Microsurgical, Inc.	1996	—
−6	K031685	Tag Rod Bioraptor Suture Anchor 7209317, 7209318	Smith & Nephew, Inc.	2003	5
−5	K053344	Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…	Smith & Nephew, Inc.	2006	—
−4	K061863	Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family	Arthrex, Inc.	2006	—
−3	K071177	Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite…	Arthrex, Inc.	2007	—
−2	K082810	Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock…	Arthrex, Inc.	2009	—
−1	K101679	Arthrex Pushlock Anchors	Arthrex, Inc.	2010	—
0 (this device)	K232492	2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless…	Medos International SARL	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2009	1	0

FIG. 1 — Lineage of K232492, 1996–2023Source: 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 MBI? 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 MBI device

#1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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? (1)

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
*	K101679	Arthrex Pushlock Anchors Summary page 7 …The GRYPHON Flex Knotless PEEK and BIOCOMPOSITE Anchors are substantially equivalent to: • K101679, Arthrex PushLock Anchors (BIOCOMPOSITE) Reference Devices:…	Arthrex, Inc.	2010	—
†	K182941	HEALIX ADVANCE SP PEEK Anchor	Medos International SARL	2019	—
†	K201883	6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor	Medos International SARL	2020	—
†	K191242	HEALIX ADVANCE SP BIOCOMPOSITE Anchor	Medos International SARL	2019	—
†	K140643	Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot Technology	Depuy Mitek, A Johnson and Johnson Company	2014	—
†	K040004	Orthocord Suture	Depuy Mitek	2004	1
†	K181182	DYNACORD Suture	Medos International SARL	2018	—

Also cleared against K101679: 20 other devices →

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 4 companies; a new generation was cleared every 1.7 years on median.
2 of the 9 ancestors have a recall of any class.
20 other devices also cite its predicate K101679.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · MBI

27in 2025

2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007high 24 (2007) · low 0 (2014)2026

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

Adverse event reports per year · MBI

3,826in 2025

2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, 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	16	80	24	240
2008	10	69	6	338
2009	19	82	2	355
2010	17	76	3	291
2011	30	75	23	328
2012	24	94	6	371
2013	31	100	2	442
2014	23	101	0	504
2015	23	85	0	507
2016	17	94	0	795
2017	17	70	4	675
2018	16	91	2	1,072
2019	31	90	0	1,303
2020	35	83	1	1,454
2021	18	107	0	1,890
2022	19	64	0	1,591
2023	52	57	1	2,503
2024	22	30	1	3,779
2025	27	58	1	3,826
2026	30	63	0	—

What is it indicated for?

The GRYPHON™ Flex Knotless Anchor is indicated for use for reattachment of soft tissue to bone for the following procedures: Indication PEEK BIOCRYL Bankart Repair X X SLAP Lesion Repair X X Shoulder Capsular Shift or Capsulolabral Reconstruction X X Superior Capsule Reconstruction (Glenoid Only) X X Hip Acetabular Labral Repair X X MCL X X Knee LCL X X Iliotibial Band Tenodesis X X Lateral Stabilization X Foot/Ankle Medial Stabilization X

Read the full statement (72 words)

The GRYPHON™ Flex Knotless Anchor is indicated for use for reattachment of soft tissue to bone for the following procedures:

Indication PEEK BIOCRYL

Bankart Repair X X

SLAP Lesion Repair X X

Shoulder

Capsular Shift or Capsulolabral Reconstruction X X

Superior Capsule Reconstruction (Glenoid Only) X X

Hip Acetabular Labral Repair X X

MCL X X

Knee LCL X X

Iliotibial Band Tenodesis X X

Lateral Stabilization X

Foot/Ankle

Medial Stabilization X

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K232492 · printed Nov 6, 2026

Cite this page

510(k) Report. “K232492: 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232492

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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