# K232492: 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Oct 6, 2023 after 50 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K961555 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101679: Arthrex Pushlock Anchors, Arthrex, Inc. (2010) Summary page 7.

## Indications for use
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

Source page: https://510kreport.com/device/K232492
Methodology: https://510kreport.com/methodology