Fixone Biocomposite Anchor

GUDID 08800039102308

The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor ismanufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver. B,N,BN type(Knotted suture anchors) are ‘screw-in’ anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair. Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type. SL type ‘push-in’ anchors that are ideal for soft-tissue repair in narrow or deep areas. S type are ‘push-in’ anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone. Devices are provided sterile. Single use only.

AJU PHARM. CO., LTD.

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 08800039102308
• NIH Device Record Key: 23e051e7-6475-4ea6-926d-4d1902dbfd07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixone Biocomposite Anchor
• Version Model Number: SAL-30002ni
• 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	08800039102308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230892

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 Biocomposite Anchor]

• 08806109701068: The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The
• 08800039102308: The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The
• 08800039101011: The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The
• 08800039101004: The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The
• 08800039100991: The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The
• 08800039100984: The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The
• 08800039100809: The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The
• 08800039100786: The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The
• 08800039100380: The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The
• 08800039100335: The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The
• 08800039100083: The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The
• 08800039100045: The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The
• 08800039100038: The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The
• 08800039100021: The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The