Fixone Hybrid Anchor

GUDID 08800039101035

The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE only or UHMWPE and PET fibers is inserted into the anchor. The anchor is implanted using a provided driver.

AJU PHARM. CO., LTD.

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 08800039101035
• NIH Device Record Key: 377d229b-db5d-45db-8b07-6c1b83cd0e48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixone Hybrid Anchor
• Version Model Number: KAPN-55001c
• Company DUNS: 963422810
• Company Name: AJU PHARM. CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800039101035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203523

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, Soft Tissue

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-14
• Device Publish Date: 2025-01-06

On-Brand Devices [Fixone Hybrid Anchor]

• 08800039102254: The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures.
• 08800039102216: The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures.
• 08800039101035: The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures.
• 08800039101028: The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures.
• 08800039100601: The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures.
• 08800039100571: The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures.